Fact Sheet For Patients: Understanding Swine Influenza Kit Test Results
May 2, 2009
An emergency has been declared by the Secretary of Health and Human Services because of the 2009 outbreak caused by a novel H1N1 flu virus. Novel means that the virus was newly found. This virus has also been referred to as swine influenza (H1N1) virus. This Fact Sheet will refer to the virus as novel influenza A (H1N1) virus.
The Food and Drug Administration (FDA) has authorized the emergency use of the Swine Influenza Test Kit to test for the presence of novel H1N1 flu virus. This authorization will terminate on April 26, 2010, when the emergency has ceased to exist, or when the authorization has been revoked, whichever is earlier. The information in this Fact Sheet is the minimum necessary to inform you of the significant known and potential risks and benefits of the emergency use of the Swine Influenza Test Kit.
Why was my sample tested using the Swine Influenza Test Kit?
There are no FDA cleared or approved tests that can identify novel H1N1 flu virus. Therefore, y our sample was tested using the Swine Influenza Test Kit because you may have been infected with the novel H1N1 flu virus. This test could help to determine whether you are infected with the novel H1N1 flu virus, so that public health officials could quickly identify a case and limit its spread. The results of this test, along with other information, may also help your doctor take better care of you.
What is novel H1N1 flu?
Novel H1N1 flu is a respiratory disease caused by type A influenza virus . Human cases of novel H1N1 flu virus infection have been identified in the United States and internationally. CDC has determined that this virus is contagious and is spreading from human to human. Like seasonal flu, novel H1N1 flu in humans can vary in severity from mild to severe.
What is the Swine Influenza Test Kit?
The Swine Influenza Test Kit is believed to be a good test to detect the novel H1N1 flu virus. The FDA has not cleared or approved this test. The FDA has agreed that we can use this test under an Emergency Use Authorization. We don’t know for sure if this test can identify all people who may get sick with novel H1N1 flu.
What are the known risks and benefits of Swine Influenza Test Kit?
The results of this test from nasopharyngeal swabs, nasal swabs, throat swabs, dual nasopharyngeal swabs/throat swabs, and nasal aspirates, along with other information, can help your doctor take better care of you. Knowing your test results may help you to prevent the spread of the virus to your family or others.
If this test is positive, does that mean that I have novel H1N1 flu?
Yes, although there is a very small chance that this test can give a result that is wrong (false positive), it is not likely. If your result from this test is positive, your doctor may decide how to care for you based on the test results along with other factors.
If this test is negative, does that mean that I do not have novel H1N1 flu?
If this test is negative you may be sick with something that is not novel H1N1 flu. There is a small chance that this test can give a result that is wrong (false negative). A false negative result should not affect your care. No changes in your medical care should be solely based on a negative result.
* Any significant new findings observed during the course of the emergency use of Swine Influenza Test Kit will be made available at http://www.cdc.gov/h1n1flu/.
http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161580.htm - - Updated: 06/18/2009
Friday, June 26, 2009
Saturday, June 20, 2009
Vaccinate Kids to Control H1N1 Flu
From Reuters Health Information
LONDON (Reuters) Jun 18 - Targeting children for vaccination may be the best way of using limited supplies of vaccine to control the current H1N1 flu pandemic, British researchers said on Thursday.
Drugmakers are racing to make a vaccine against the new flu strain but if the disease increases significantly in the northern hemisphere autumn, as many experts fear, there are unlikely to be enough shots to vaccinate entire populations.
Researchers from the University of Warwick said that vaccinating children rather than adults would not only help protect a group at greatest risk of exposure to the virus, but would also offer protection to unvaccinated adults.
This so-called "herd immunity" effect would mean significantly less vaccine would be needed to help control the spread of H1N1, also known as swine flu, which was first detected in Mexico in April.
"Our models suggest that the larger the household -- which in most cases means the more children living at home -- the more likely the infection is to spread," said researcher Matt Keeling.
"This doesn't mean that everyone in the household needs to be vaccinated but suggests that vaccination programmes for children might help control a potential pandemic."
Keeling and colleague Thomas House used computer modelling to predict the spread of pandemic influenza and published their findings in the journal Epidemiology and Infection.
Leading flu vaccine makers include Sanofi-Aventis, GlaxoSmithKline and Novartis.
LONDON (Reuters) Jun 18 - Targeting children for vaccination may be the best way of using limited supplies of vaccine to control the current H1N1 flu pandemic, British researchers said on Thursday.
Drugmakers are racing to make a vaccine against the new flu strain but if the disease increases significantly in the northern hemisphere autumn, as many experts fear, there are unlikely to be enough shots to vaccinate entire populations.
Researchers from the University of Warwick said that vaccinating children rather than adults would not only help protect a group at greatest risk of exposure to the virus, but would also offer protection to unvaccinated adults.
This so-called "herd immunity" effect would mean significantly less vaccine would be needed to help control the spread of H1N1, also known as swine flu, which was first detected in Mexico in April.
"Our models suggest that the larger the household -- which in most cases means the more children living at home -- the more likely the infection is to spread," said researcher Matt Keeling.
"This doesn't mean that everyone in the household needs to be vaccinated but suggests that vaccination programmes for children might help control a potential pandemic."
Keeling and colleague Thomas House used computer modelling to predict the spread of pandemic influenza and published their findings in the journal Epidemiology and Infection.
Leading flu vaccine makers include Sanofi-Aventis, GlaxoSmithKline and Novartis.
Weight gain after Tonsillectomy
Adenoidectomy and Tonsillectomy Linked to Subsequent Overweight in Children
Laurie Barclay & Désirée Lie Medscape News
April 7, 2009 — Tonsillectomy with or without adenoidectomy, or (adeno)tonsillectomy, are linked to subsequent overweight in children, according to the results of a study reported in the April issue of Pediatrics.
"Studies among patients have shown accelerated weight gain after (adeno)tonsillectomy," write Alet H. Wijga, PhD, from the Centre for Prevention and Health Services Research, National Institute for Public Health and the Environment, Bilthoven, Netherlands, and colleagues. "Whether (adeno)tonsillectomy is also a risk factor for the development of overweight is unknown. We investigated the association between (adeno)tonsillectomy and the subsequent development of overweight in the general population."
The study sample included 3963 children enrolled in the Dutch Prevention and Incidence of Asthma and Mite Allergy birth cohort. Annual questionnaires completed by the parents provided data on weight and height; adenoidectomy and tonsillectomy; and covariates including sex, birth weight, maternal education, maternal overweight, maternal smoking during pregnancy, breast-feeding, and smoking in the home. The investigators also measured the children's weight and height at 8 years of age.
Undergoing (adeno)tonsillectomy from birth to age 7 was significantly associated with overweight and obesity at 8 years of age. Being overweight at 2 years of age did not predict increased risk for (adeno)tonsillectomy at older ages, suggesting that preexisting overweight did not explain the association between (adeno)tonsillectomy and overweight.
"Longitudinal data on weight and height in the years before and after surgery suggest that (adeno)tonsillectomy forms a turning point between a period of growth faltering and a period of catch-up growth, which might explain the increased risk to develop overweight after the operation," the study authors write. "Children who undergo (adeno)tonsillectomy are at increased risk to develop overweight in the years after surgery."
Limitations of this study include loss to follow-up for the medical examination where weight and height were measured and that most data were parental reported.
"Dietary and lifestyle advice at the time of surgery and growth monitoring thereafter might help parents to keep their child's catch-up growth within healthy limits," the study authors conclude.
Pediatrics. 2009;123:1095–1101.
Clinical Context
Accelerated weight gain has been observed in several studies after adenoidectomy and tonsillectomy, but this has not been considered a risk factor for overweight and obesity in children. In the Netherlands, the rate of the procedures is higher than in the rest of Europe or the United States.
This is a follow-up study of a birth cohort in the Netherlands followed up from birth to age 8 years to examine the cumulative incidence of the procedures and the effect of either adenoidectomy alone or adenoidectomy and tonsillectomy from age 0 to 7 years on the risk for overweight and obesity at 8 years of age.
Pearls for Practice
•The cumulative incidence of adenoidectomy and (adeno)tonsillectomy to age 8 years are 12% and 15%, respectively, and 70% of those who undergo adenoidectomy and tonsillectomy have both procedures at the same age.
•(Adeno)tonsillectomy between 0 and 7 years are associated with a increased risk for overweight and obesity at 8 years.
Laurie Barclay & Désirée Lie Medscape News
April 7, 2009 — Tonsillectomy with or without adenoidectomy, or (adeno)tonsillectomy, are linked to subsequent overweight in children, according to the results of a study reported in the April issue of Pediatrics.
"Studies among patients have shown accelerated weight gain after (adeno)tonsillectomy," write Alet H. Wijga, PhD, from the Centre for Prevention and Health Services Research, National Institute for Public Health and the Environment, Bilthoven, Netherlands, and colleagues. "Whether (adeno)tonsillectomy is also a risk factor for the development of overweight is unknown. We investigated the association between (adeno)tonsillectomy and the subsequent development of overweight in the general population."
The study sample included 3963 children enrolled in the Dutch Prevention and Incidence of Asthma and Mite Allergy birth cohort. Annual questionnaires completed by the parents provided data on weight and height; adenoidectomy and tonsillectomy; and covariates including sex, birth weight, maternal education, maternal overweight, maternal smoking during pregnancy, breast-feeding, and smoking in the home. The investigators also measured the children's weight and height at 8 years of age.
Undergoing (adeno)tonsillectomy from birth to age 7 was significantly associated with overweight and obesity at 8 years of age. Being overweight at 2 years of age did not predict increased risk for (adeno)tonsillectomy at older ages, suggesting that preexisting overweight did not explain the association between (adeno)tonsillectomy and overweight.
"Longitudinal data on weight and height in the years before and after surgery suggest that (adeno)tonsillectomy forms a turning point between a period of growth faltering and a period of catch-up growth, which might explain the increased risk to develop overweight after the operation," the study authors write. "Children who undergo (adeno)tonsillectomy are at increased risk to develop overweight in the years after surgery."
Limitations of this study include loss to follow-up for the medical examination where weight and height were measured and that most data were parental reported.
"Dietary and lifestyle advice at the time of surgery and growth monitoring thereafter might help parents to keep their child's catch-up growth within healthy limits," the study authors conclude.
Pediatrics. 2009;123:1095–1101.
Clinical Context
Accelerated weight gain has been observed in several studies after adenoidectomy and tonsillectomy, but this has not been considered a risk factor for overweight and obesity in children. In the Netherlands, the rate of the procedures is higher than in the rest of Europe or the United States.
This is a follow-up study of a birth cohort in the Netherlands followed up from birth to age 8 years to examine the cumulative incidence of the procedures and the effect of either adenoidectomy alone or adenoidectomy and tonsillectomy from age 0 to 7 years on the risk for overweight and obesity at 8 years of age.
Pearls for Practice
•The cumulative incidence of adenoidectomy and (adeno)tonsillectomy to age 8 years are 12% and 15%, respectively, and 70% of those who undergo adenoidectomy and tonsillectomy have both procedures at the same age.
•(Adeno)tonsillectomy between 0 and 7 years are associated with a increased risk for overweight and obesity at 8 years.
Friday, June 19, 2009
AAP Recommendations in Lipid screening & CVS Health
Obesity Epidemic in Children Fuels Need for New Recommendations in Lipid Screening and Cardiovascular Health
Michael O'Riordan & Charles Vega Medscape News
July 7, 2008 — The American Academy of Pediatrics has issued a new clinical report on lipid screening and cardiovascular health in children [1], a report that has taken on new urgency given the epidemic of childhood obesity and the subsequent increased risks of type 2 diabetes mellitus, hypertension, and cardiovascular disease, say its authors.
The new report is published in the July 1, 2008 issue of Pediatrics and replaces the 1998 policy statement, "Cholesterol in Childhood." New data, write the authors, emphasize the negative effects of the excess dietary intake of saturated fats, trans fats, and cholesterol, and the effects of carbohydrates, the obesity epidemic, the metabolic/insulin resistance syndrome, and the decreased level of physical activity and fitness on the risk of adult-onset cardiovascular disease.
"In addition," write Daniels and colleagues, "more data are now available on the safety and efficiency of pharmacologic agents used to treat dyslipidemia. Most of these data were not available at the time of the previous statement."
The recommendations
The new report recommends a diet for all children older than 2 years that is based on the Dietary Guidelines for Americans, which is published by the Department of Health and Human Services and the Department of Agriculture.
For children or adolescents at higher risk for cardiovascular disease or with elevated low-density lipoprotein (LDL)–cholesterol levels, changes in diet based on nutritional counseling and other lifestyle modifications are also recommended.
For overweight or obese pediatric patients with high triglyceride levels or low high-density lipoprotein (HDL)-cholesterol levels, weight management is the primary treatment, and includes improvement in diet with nutritional counseling and increased physical activity.
The writing committee also states that the current recommendation is to screen children and adolescents with a positive family history of dyslipidemia or premature cardiovascular disease.
It is recommended that pediatric patients for whom family history is not known and those with other cardiovascular risk factors, such as being overweight, obesity, hypertension, smoking history, and diabetes mellitus, be screened with a fasting-lipid profile.
Screening should take place after 2 years of age, but no later than 10 years of age.
Clinical Context
By approximately 2 years of age, most children have lipid concentrations that approximate those of young adults. Girls usually have higher total and LDL cholesterol levels vs boys, and adolescent girls also generally have higher HDL cholesterol levels vs postpubertal boys.
In a national study among US adolescents completed between 1988 and 1994, there were 10% of participants who had total control cholesterol concentrations that exceeded 200 mg/dL. The current clinical report describes screening and treatment recommendations for dyslipidemia among children.
Study Highlights
•A healthful, low-fat diet should be recommended to all children older than 2 years, and some research suggests that limiting fat in children younger than 2 years has no negative effect on growth or neurologic function. Reduced-fat milk may be appropriate for children beginning at age 12 months if there is concern for overweight or obesity, or if a family history of cardiovascular disease is present.
Only children at increased risk for future cardiovascular events should receive routine screening for serum lipid concentrations.
Children and adolescents with any of the following risk factors should receive screening:
◦Family history of dyslipidemia
◦Family history of premature cardiovascular disease
◦Overweight or obese children
◦Children with hypertension
◦Children who smoke cigarettes
◦Children with diabetes mellitus
•Children who qualify for screening should receive a full fasting lipid profile.
•At-risk children should be screened after age 2 years but no later than age 10 years.
•Children with normal lipid values at screening may be retested in 3 to 5 years.
All children with abnormal lipid levels should receive education on diet and exercise. This is particularly important for pediatric patients whose primary lipid level abnormality is a high triglyceride or low HDL cholesterol level.
Pharmacologic treatment should be considered for children who are at least 8 years old and meet one of the following qualifications:
◦LDL cholesterol level at least 190 mg/dL
◦LDL cholesterol level at least 160 mg/dL with a family history of premature cardiovascular disease or at least 2 other risk factors present
◦LDL cholesterol level at least 130 mg/dL and patient has diabetes
•Pharmacologic treatment may be considered for LDL cholesterol levels as low as 110 mg/dL if there are very compelling indications.
•Bile acid-binding resins can reduce cholesterol levels by 10% to 20%, and these medications do not have systemic effects.
•Statins have been demonstrated to be effective in short-term studies in children and have also been demonstrated to reduce atherosclerosis in children with hyperlipidemia.
•Fibrates should be reserved for use in special clinics for children with hyperlipidemia. Because of a high rate of adverse events such as flushing (up to three quarters of treated patients) and elevated transaminase concentrations (26% of children in 1 study), niacin should be avoided for the treatment of pediatric dyslipidemia.
Pearls for Practice
•The current clinical report suggests that children and adolescents with a family history of dyslipidemia, a family history of premature cardiovascular disease, or a personal history of overweight or obesity, hypertension, cigarette smoking, or diabetes should receive routine screening for serum lipid concentrations.
•Bile acid-binding resins and statins are the most recommended medical treatments for the management of pediatric dyslipidemia, and fibrates may be used by specialists in these disorders. The use of niacin is discouraged in children.
Source
Daniels SR, Greer FR, and the Committee on Nutrition. Lipid screening and cardiovascular health. Pediatrics. 2008;122:198-208.
Heartwire at www.theheart.org
Michael O'Riordan & Charles Vega Medscape News
July 7, 2008 — The American Academy of Pediatrics has issued a new clinical report on lipid screening and cardiovascular health in children [1], a report that has taken on new urgency given the epidemic of childhood obesity and the subsequent increased risks of type 2 diabetes mellitus, hypertension, and cardiovascular disease, say its authors.
The new report is published in the July 1, 2008 issue of Pediatrics and replaces the 1998 policy statement, "Cholesterol in Childhood." New data, write the authors, emphasize the negative effects of the excess dietary intake of saturated fats, trans fats, and cholesterol, and the effects of carbohydrates, the obesity epidemic, the metabolic/insulin resistance syndrome, and the decreased level of physical activity and fitness on the risk of adult-onset cardiovascular disease.
"In addition," write Daniels and colleagues, "more data are now available on the safety and efficiency of pharmacologic agents used to treat dyslipidemia. Most of these data were not available at the time of the previous statement."
The recommendations
The new report recommends a diet for all children older than 2 years that is based on the Dietary Guidelines for Americans, which is published by the Department of Health and Human Services and the Department of Agriculture.
For children or adolescents at higher risk for cardiovascular disease or with elevated low-density lipoprotein (LDL)–cholesterol levels, changes in diet based on nutritional counseling and other lifestyle modifications are also recommended.
For overweight or obese pediatric patients with high triglyceride levels or low high-density lipoprotein (HDL)-cholesterol levels, weight management is the primary treatment, and includes improvement in diet with nutritional counseling and increased physical activity.
The writing committee also states that the current recommendation is to screen children and adolescents with a positive family history of dyslipidemia or premature cardiovascular disease.
It is recommended that pediatric patients for whom family history is not known and those with other cardiovascular risk factors, such as being overweight, obesity, hypertension, smoking history, and diabetes mellitus, be screened with a fasting-lipid profile.
Screening should take place after 2 years of age, but no later than 10 years of age.
Clinical Context
By approximately 2 years of age, most children have lipid concentrations that approximate those of young adults. Girls usually have higher total and LDL cholesterol levels vs boys, and adolescent girls also generally have higher HDL cholesterol levels vs postpubertal boys.
In a national study among US adolescents completed between 1988 and 1994, there were 10% of participants who had total control cholesterol concentrations that exceeded 200 mg/dL. The current clinical report describes screening and treatment recommendations for dyslipidemia among children.
Study Highlights
•A healthful, low-fat diet should be recommended to all children older than 2 years, and some research suggests that limiting fat in children younger than 2 years has no negative effect on growth or neurologic function. Reduced-fat milk may be appropriate for children beginning at age 12 months if there is concern for overweight or obesity, or if a family history of cardiovascular disease is present.
Only children at increased risk for future cardiovascular events should receive routine screening for serum lipid concentrations.
Children and adolescents with any of the following risk factors should receive screening:
◦Family history of dyslipidemia
◦Family history of premature cardiovascular disease
◦Overweight or obese children
◦Children with hypertension
◦Children who smoke cigarettes
◦Children with diabetes mellitus
•Children who qualify for screening should receive a full fasting lipid profile.
•At-risk children should be screened after age 2 years but no later than age 10 years.
•Children with normal lipid values at screening may be retested in 3 to 5 years.
All children with abnormal lipid levels should receive education on diet and exercise. This is particularly important for pediatric patients whose primary lipid level abnormality is a high triglyceride or low HDL cholesterol level.
Pharmacologic treatment should be considered for children who are at least 8 years old and meet one of the following qualifications:
◦LDL cholesterol level at least 190 mg/dL
◦LDL cholesterol level at least 160 mg/dL with a family history of premature cardiovascular disease or at least 2 other risk factors present
◦LDL cholesterol level at least 130 mg/dL and patient has diabetes
•Pharmacologic treatment may be considered for LDL cholesterol levels as low as 110 mg/dL if there are very compelling indications.
•Bile acid-binding resins can reduce cholesterol levels by 10% to 20%, and these medications do not have systemic effects.
•Statins have been demonstrated to be effective in short-term studies in children and have also been demonstrated to reduce atherosclerosis in children with hyperlipidemia.
•Fibrates should be reserved for use in special clinics for children with hyperlipidemia. Because of a high rate of adverse events such as flushing (up to three quarters of treated patients) and elevated transaminase concentrations (26% of children in 1 study), niacin should be avoided for the treatment of pediatric dyslipidemia.
Pearls for Practice
•The current clinical report suggests that children and adolescents with a family history of dyslipidemia, a family history of premature cardiovascular disease, or a personal history of overweight or obesity, hypertension, cigarette smoking, or diabetes should receive routine screening for serum lipid concentrations.
•Bile acid-binding resins and statins are the most recommended medical treatments for the management of pediatric dyslipidemia, and fibrates may be used by specialists in these disorders. The use of niacin is discouraged in children.
Source
Daniels SR, Greer FR, and the Committee on Nutrition. Lipid screening and cardiovascular health. Pediatrics. 2008;122:198-208.
Heartwire at www.theheart.org
Thursday, June 18, 2009
Avoid TV in children under 2 years?
Study Confirms TV Viewing Deleterious for Very Young Children
by Rosemary Frei
From Medscape Medical News
June 11, 2009 — Infants vocalize significantly less, and the adults who are with them also speak much less, while they are watching TV, a study published in the June issue of the Archives of Pediatric and Adolescent Medicine has confirmed.
Researchers analyzed digital recordings of 2- to 48-month-old children and their parents that were made once a month on random days for up to 2 years. Each hour of audible television was associated with a significant drop in how much the children vocalized and engaged in conversational exchanges with the adults present.
The adults also spoke 770 fewer words during each hour that the TV was audible — a dramatic bite out of the average 940 word-per-hour rate adults usually speak.
"That 770-word reduction is almost a complete 1-to-1 displacement [of the amount adults talk]," said lead investigator Dimitri Christakis, MD, from the Center for Child Health, Behavior, and Development at the Seattle Children's Research Institute and the University of Washington School of Medicine.
The American Academy of Pediatrics recommends that TV exposure should be avoided in children under the age of 2 years and that older children should view only 2 or fewer hours of TV per day. This is to ensure that children engage in as much interaction as possible with adults and thus have normal language development and brain growth.
A Major Problem
Benard Dreyer, MD, from Bellevue Hospital and the New York University School of Medicine, in New York City, was an author of a previous, retrospective study of low-income families that also showed TV exposure is associated with less parent-child vocal interaction (Mendelsohn AL et al. Arch Pediatr Adolesc Med. 2008;162:411-417). He said he "completely" agrees with the veracity of the new study's findings.
"I think that this [TV watching by young children] is a major problem, especially with respect to language development and all other types of early-childhood development that are predicated on interacting with adults, including cognitive development," Dr. Dreyer told Medscape Psychiatry. "Children who are interacting less with their parents and hearing less language are going to develop less language and also fewer other cognitive skills," he added.
Dr. Christakis and his colleagues obtained the data for the study from the LENA Foundation Natural Language Study. In the study, parents and their children aged 2 to 48 months were recruited and matched to the national-average levels of maternal education and child sex. The parents agreed to put a digital language-processing device in the front pocket of a specially designed vest that their child wore once a month for up to 24 months.
A total of 329 child-parent pairs contributed at least 1 recording with usable speech data to the study. The children's average age at the first session was 18 months, 51% were boys, and 79% were white; they were exposed to a mean of 1.3 hours of audible TV per day.
The investigators performed regression analyses that revealed that television exposure was linked with significantly reduced child vocalization count and duration as well as reduced conversation. These effects increased with every additional hour per day of television exposure.
Likewise, every additional hour of television exposure was associated with a 636-word decrease in the number of words the children heard from the female adults in their vicinity and a 134-word decrease in words heard from adult males, for a total reduction of 770 adult words.
Arch Pediatr Adolesc Med. 2009;163: 554-558. Abstract
by Rosemary Frei
From Medscape Medical News
June 11, 2009 — Infants vocalize significantly less, and the adults who are with them also speak much less, while they are watching TV, a study published in the June issue of the Archives of Pediatric and Adolescent Medicine has confirmed.
Researchers analyzed digital recordings of 2- to 48-month-old children and their parents that were made once a month on random days for up to 2 years. Each hour of audible television was associated with a significant drop in how much the children vocalized and engaged in conversational exchanges with the adults present.
The adults also spoke 770 fewer words during each hour that the TV was audible — a dramatic bite out of the average 940 word-per-hour rate adults usually speak.
"That 770-word reduction is almost a complete 1-to-1 displacement [of the amount adults talk]," said lead investigator Dimitri Christakis, MD, from the Center for Child Health, Behavior, and Development at the Seattle Children's Research Institute and the University of Washington School of Medicine.
The American Academy of Pediatrics recommends that TV exposure should be avoided in children under the age of 2 years and that older children should view only 2 or fewer hours of TV per day. This is to ensure that children engage in as much interaction as possible with adults and thus have normal language development and brain growth.
A Major Problem
Benard Dreyer, MD, from Bellevue Hospital and the New York University School of Medicine, in New York City, was an author of a previous, retrospective study of low-income families that also showed TV exposure is associated with less parent-child vocal interaction (Mendelsohn AL et al. Arch Pediatr Adolesc Med. 2008;162:411-417). He said he "completely" agrees with the veracity of the new study's findings.
"I think that this [TV watching by young children] is a major problem, especially with respect to language development and all other types of early-childhood development that are predicated on interacting with adults, including cognitive development," Dr. Dreyer told Medscape Psychiatry. "Children who are interacting less with their parents and hearing less language are going to develop less language and also fewer other cognitive skills," he added.
Dr. Christakis and his colleagues obtained the data for the study from the LENA Foundation Natural Language Study. In the study, parents and their children aged 2 to 48 months were recruited and matched to the national-average levels of maternal education and child sex. The parents agreed to put a digital language-processing device in the front pocket of a specially designed vest that their child wore once a month for up to 24 months.
A total of 329 child-parent pairs contributed at least 1 recording with usable speech data to the study. The children's average age at the first session was 18 months, 51% were boys, and 79% were white; they were exposed to a mean of 1.3 hours of audible TV per day.
The investigators performed regression analyses that revealed that television exposure was linked with significantly reduced child vocalization count and duration as well as reduced conversation. These effects increased with every additional hour per day of television exposure.
Likewise, every additional hour of television exposure was associated with a 636-word decrease in the number of words the children heard from the female adults in their vicinity and a 134-word decrease in words heard from adult males, for a total reduction of 770 adult words.
Arch Pediatr Adolesc Med. 2009;163: 554-558. Abstract
Adverse Postnatal effects of multiple doses of Antenatal Steroids
Multiple Courses of Antenatal Steroids Not Recommended for Preterm Birth
Laurie Barclay, MD
From Medscape Medical News
December 22, 2008 — Multiple courses of antenatal steroids every 14 days do not improve preterm birth outcomes, are linked to decreased size at birth, and are therefore not recommended, according to the results of a study reported in the December 20/27 issue of The Lancet.
"One course of antenatal corticosteroids reduces the risk of respiratory distress syndrome and neonatal death," write Kellie E. Murphy, from Mount Sinai Hospital, University of Toronto in Toronto, Ontario, Canada, and colleagues from the MACS Collaborative Group.
The study sample consisted of 1,858 women at 25 to 32 weeks of gestation who were at high risk for preterm birth, who were still undelivered 14 to 21 days after an initial course of antenatal corticosteroids, and who continued to be at high risk. Participants were randomly assigned to receive multiple courses of antenatal corticosteroids (n = 937) or placebo (n = 921), every 14 days until week 33 or delivery, whichever came first.
Compared with infants exposed to placebo, those exposed to multiple courses of antenatal corticosteroids had similar morbidity and mortality rates, with the main study endpoint occurring in 150 (12.9%) vs 143 (12.5%). Compared with infants in the placebo group, those in the multiple-dose corticosteroid group had lower birth weight (2,216 vs 2,330 g; P = .0026), shorter length (44.5 vs 45.4 cm; P < .001), and smaller head circumference (31.1 vs 31.7 cm; P < .001).
"Multiple courses of antenatal corticosteroids, every 14 days, do not improve preterm-birth outcomes, and are associated with a decreased weight, length, and head circumference at birth," the study authors write. "Therefore, this treatment schedule is not recommended."
In an accompanying comment, John P. Newnham, from the School of Women's and Infants' Health, University of Western Australia in Perth, and Karen Simmer, from King Edward and Princess Margaret Hospitals in Perth, note that follow-up of the children in this study will help shed light on any long-term effects of multiple doses of antenatal corticosteroids.
"Particular attention should be paid to those areas in which other studies have suggested problems, including behaviour, growth, glucose tolerance, and blood pressure," Drs. Newnham and Simmer write. "In the meantime, the evidence suggests it is prudent for obstetricians not to prescribe repeat injections of antenatal corticosteroids. Single-course therapy is of considerable benefit, but we should be aware of the potential dangers of giving too much of a good thing."
Lancet. 2008;372:2094-2095, 2143-2151.
Laurie Barclay, MD
From Medscape Medical News
December 22, 2008 — Multiple courses of antenatal steroids every 14 days do not improve preterm birth outcomes, are linked to decreased size at birth, and are therefore not recommended, according to the results of a study reported in the December 20/27 issue of The Lancet.
"One course of antenatal corticosteroids reduces the risk of respiratory distress syndrome and neonatal death," write Kellie E. Murphy, from Mount Sinai Hospital, University of Toronto in Toronto, Ontario, Canada, and colleagues from the MACS Collaborative Group.
The study sample consisted of 1,858 women at 25 to 32 weeks of gestation who were at high risk for preterm birth, who were still undelivered 14 to 21 days after an initial course of antenatal corticosteroids, and who continued to be at high risk. Participants were randomly assigned to receive multiple courses of antenatal corticosteroids (n = 937) or placebo (n = 921), every 14 days until week 33 or delivery, whichever came first.
Compared with infants exposed to placebo, those exposed to multiple courses of antenatal corticosteroids had similar morbidity and mortality rates, with the main study endpoint occurring in 150 (12.9%) vs 143 (12.5%). Compared with infants in the placebo group, those in the multiple-dose corticosteroid group had lower birth weight (2,216 vs 2,330 g; P = .0026), shorter length (44.5 vs 45.4 cm; P < .001), and smaller head circumference (31.1 vs 31.7 cm; P < .001).
"Multiple courses of antenatal corticosteroids, every 14 days, do not improve preterm-birth outcomes, and are associated with a decreased weight, length, and head circumference at birth," the study authors write. "Therefore, this treatment schedule is not recommended."
In an accompanying comment, John P. Newnham, from the School of Women's and Infants' Health, University of Western Australia in Perth, and Karen Simmer, from King Edward and Princess Margaret Hospitals in Perth, note that follow-up of the children in this study will help shed light on any long-term effects of multiple doses of antenatal corticosteroids.
"Particular attention should be paid to those areas in which other studies have suggested problems, including behaviour, growth, glucose tolerance, and blood pressure," Drs. Newnham and Simmer write. "In the meantime, the evidence suggests it is prudent for obstetricians not to prescribe repeat injections of antenatal corticosteroids. Single-course therapy is of considerable benefit, but we should be aware of the potential dangers of giving too much of a good thing."
Lancet. 2008;372:2094-2095, 2143-2151.
Tuesday, June 16, 2009
Long-Term Steroid Asthma Therapy Increases Fracture Risk in Children, Teens
Laurie Barclay & Désirée Lie
MEDSCAPE NEWS
July 7, 2008 — Long-term use of corticosteroids for asthma treatment may increase fracture risk in male children and teens, according to the results of a cohort follow-up study reported in the July issue of Pediatrics.
"Systemic corticosteroids are known to induce osteoporosis and increase the risk for fractures in adults and children," write H. William Kelly, PharmD, from the University of New Mexico Health Sciences Center in Albuquerque, and colleagues from the Childhood Asthma Management Program (CAMP) Research Group.
"Inhaled corticosteroids have been shown to increase the risk for osteoporosis and fractures in adults at risk; however, long-term prospective studies of children to assess risks of multiple short courses of oral corticosteroids and chronic inhaled corticosteroids have not been performed. Thus, we assessed the effects of multiple short courses of oral corticosteroids and long-term inhaled corticosteroids on bone mineral accretion over a period of years."
This study was a follow-up of children with mild to moderate asthma who were initially randomized in the CAMP trial. All patients had serial dual-energy radiographic absorptiometry scans of the lumbar spine for bone mineral density. Median duration of follow-up was 7 years. Of the initial cohort, 84% of those with asthma who were aged 5 to 12 years at baseline (531 boys and 346 girls) underwent calculation of annual bone mineral accretion.
In boys but not girls, therapy with oral corticosteroid bursts was associated with a dosage-dependent decrease in bone mineral accretion (0.052, 0.049, and 0.046 g/cm2 per year) and an increased risk for osteopenia (10%, 14%, and 21%) for 0, 1 to 4, and 5 or more courses, respectively.
Cumulative inhaled corticosteroid use was linked to a small reduction in bone mineral accretion in boys but not in girls, but not to an increased risk for osteopenia in children of either sex.
Limitations of this study include therapy during follow-up controlled by the primary care clinician, failure to control for asthma severity, and lack of accepted normal values for bone mineral density in children to establish z scores to define osteopenia and osteoporosis.
"Multiple oral corticosteroid bursts over a period of years can produce a dosage-dependent reduction in bone mineral accretion and increased risk for osteopenia in children with asthma," the study authors write.
"Inhaled corticosteroid use has the potential for reducing bone mineral accretion in male children progressing through puberty, but this risk is likely to be outweighed by the ability to reduce the amount of oral corticosteroids used in these children."
Pediatrics. 2008;122:e53-e61.
MEDSCAPE NEWS
July 7, 2008 — Long-term use of corticosteroids for asthma treatment may increase fracture risk in male children and teens, according to the results of a cohort follow-up study reported in the July issue of Pediatrics.
"Systemic corticosteroids are known to induce osteoporosis and increase the risk for fractures in adults and children," write H. William Kelly, PharmD, from the University of New Mexico Health Sciences Center in Albuquerque, and colleagues from the Childhood Asthma Management Program (CAMP) Research Group.
"Inhaled corticosteroids have been shown to increase the risk for osteoporosis and fractures in adults at risk; however, long-term prospective studies of children to assess risks of multiple short courses of oral corticosteroids and chronic inhaled corticosteroids have not been performed. Thus, we assessed the effects of multiple short courses of oral corticosteroids and long-term inhaled corticosteroids on bone mineral accretion over a period of years."
This study was a follow-up of children with mild to moderate asthma who were initially randomized in the CAMP trial. All patients had serial dual-energy radiographic absorptiometry scans of the lumbar spine for bone mineral density. Median duration of follow-up was 7 years. Of the initial cohort, 84% of those with asthma who were aged 5 to 12 years at baseline (531 boys and 346 girls) underwent calculation of annual bone mineral accretion.
In boys but not girls, therapy with oral corticosteroid bursts was associated with a dosage-dependent decrease in bone mineral accretion (0.052, 0.049, and 0.046 g/cm2 per year) and an increased risk for osteopenia (10%, 14%, and 21%) for 0, 1 to 4, and 5 or more courses, respectively.
Cumulative inhaled corticosteroid use was linked to a small reduction in bone mineral accretion in boys but not in girls, but not to an increased risk for osteopenia in children of either sex.
Limitations of this study include therapy during follow-up controlled by the primary care clinician, failure to control for asthma severity, and lack of accepted normal values for bone mineral density in children to establish z scores to define osteopenia and osteoporosis.
"Multiple oral corticosteroid bursts over a period of years can produce a dosage-dependent reduction in bone mineral accretion and increased risk for osteopenia in children with asthma," the study authors write.
"Inhaled corticosteroid use has the potential for reducing bone mineral accretion in male children progressing through puberty, but this risk is likely to be outweighed by the ability to reduce the amount of oral corticosteroids used in these children."
Pediatrics. 2008;122:e53-e61.
Rapid Weight Gain in First Three Months of Life -not good
Rapid Growth in Infancy Linked to Cardiovascular and Metabolic Risk Factors Later in Life
by Michael O’Riordan & Penny Murata
Medscape News
June 12, 2009 — Important determinants of cardiovascular disease and type 2 diabetes mellitus in adulthood are increased in infants who gain weight rapidly early in life, a new study has shown. Increased weight gain relative to height in early infancy is associated with reduced insulin sensitivity and serum high-density lipoprotein (HDL)-cholesterol levels, as well as increased waist circumference and serum triglyceride levels, report investigators.
"Rapid weight gain in the first three months of life," write Dr Ralph Leunissen (Erasmus Medical Center, Rotterdam, the Netherlands) and colleagues in the June 3, 2009 issue of the Journal of the American Medical Association, "is more detrimental than slow weight gain. More studies are required to investigate which factors determine rapid weight gain in early infancy, because those results might lead to interventions that could decrease the risk for development of cardiovascular disease and type 2 diabetes later in life."
The data on birth weight and growth early in life is mixed. Some studies have shown that low birth weight is associated with cardiovascular disease and type 2 diabetes later in life, while others suggested that rapid growth patterns in infancy and childhood were an important determinant of risk later in life. Other data have shown that poor growth early in life, followed by catch-up growth after age two, is related to an increased risk of cardiovascular disease later in life.
In this study, Leunissen and colleagues wanted to determine which period in the first year of life is related to determinants of cardiovascular risk. They collected observational data from 217 participants aged 18 to 24 years participating in the Programming Factors for Growth and Metabolism (PROGRAM) study.
Weight gain in the first three months was inversely associated with insulin sensitivity and HDL-cholesterol levels. There were positive associations between weight gain during these months and waist circumference, acute insulin response, ratio of total cholesterol to HDL cholesterol, and triglyceride levels. Acute insulin response was positively associated with weight gain in months 3 to 6 after birth, but no other association was observed, including in months 6 to 9 and 9 months to one year.
A subgroup analysis was performed in 87 subjects who gained weight rapidly in the first year to assess possible relationships between the "tempo" of weight gain and determinants of cardiovascular disease and type 2 diabetes.
Individuals who gained weight rapidly during the first three months had more body fat, central adiposity, and reduced insulin sensitivity in early adulthood than those with slower growth. Rapid weight gain was defined as >0.67 standard deviation from the mean.
"This indicates that having a low birth weight for gestational age is not directly related with an unfavorable cardiovascular and metabolic profile, but increased weight gain during early childhood is," write Leunissen and colleagues, adding that the tempo of weight gain might even be more important than the timing.
The group said that the reasons for the increased cardiovascular risk are unknown, but that nutrient-enriched diets that contribute to rapid weight gain might have adverse effects of cardiovascular risk factors later in life. Formula-fed infants, for example, grow at a faster rate than breast-fed infants but are more likely to be overweight later in life. Their study, however, is limited, in that there are no nutritional data available. Future studies need to confirm these findings and to determine which factors determine weight gain, as well as to investigate associations with parental factors, such as genetics and maternal health during pregnancy.
Clinical Implications
Weight gain in the first 3 months of life is linked with reduced insulin sensitivity and serum HDL level and greater waist circumference, acute insulin response, ratio of total cholesterol to HDL cholesterol level, and triglyceride level in early adulthood.
Rapid weight gain in the first 3 months of life is linked with greater body fat percentage and central adiposity and reduced insulin sensitivity in early adulthood.
source: http://cme.medscape.com/viewarticle/704321?sssdmh=dm1.486011&src=nldne
by Michael O’Riordan & Penny Murata
Medscape News
June 12, 2009 — Important determinants of cardiovascular disease and type 2 diabetes mellitus in adulthood are increased in infants who gain weight rapidly early in life, a new study has shown. Increased weight gain relative to height in early infancy is associated with reduced insulin sensitivity and serum high-density lipoprotein (HDL)-cholesterol levels, as well as increased waist circumference and serum triglyceride levels, report investigators.
"Rapid weight gain in the first three months of life," write Dr Ralph Leunissen (Erasmus Medical Center, Rotterdam, the Netherlands) and colleagues in the June 3, 2009 issue of the Journal of the American Medical Association, "is more detrimental than slow weight gain. More studies are required to investigate which factors determine rapid weight gain in early infancy, because those results might lead to interventions that could decrease the risk for development of cardiovascular disease and type 2 diabetes later in life."
The data on birth weight and growth early in life is mixed. Some studies have shown that low birth weight is associated with cardiovascular disease and type 2 diabetes later in life, while others suggested that rapid growth patterns in infancy and childhood were an important determinant of risk later in life. Other data have shown that poor growth early in life, followed by catch-up growth after age two, is related to an increased risk of cardiovascular disease later in life.
In this study, Leunissen and colleagues wanted to determine which period in the first year of life is related to determinants of cardiovascular risk. They collected observational data from 217 participants aged 18 to 24 years participating in the Programming Factors for Growth and Metabolism (PROGRAM) study.
Weight gain in the first three months was inversely associated with insulin sensitivity and HDL-cholesterol levels. There were positive associations between weight gain during these months and waist circumference, acute insulin response, ratio of total cholesterol to HDL cholesterol, and triglyceride levels. Acute insulin response was positively associated with weight gain in months 3 to 6 after birth, but no other association was observed, including in months 6 to 9 and 9 months to one year.
A subgroup analysis was performed in 87 subjects who gained weight rapidly in the first year to assess possible relationships between the "tempo" of weight gain and determinants of cardiovascular disease and type 2 diabetes.
Individuals who gained weight rapidly during the first three months had more body fat, central adiposity, and reduced insulin sensitivity in early adulthood than those with slower growth. Rapid weight gain was defined as >0.67 standard deviation from the mean.
"This indicates that having a low birth weight for gestational age is not directly related with an unfavorable cardiovascular and metabolic profile, but increased weight gain during early childhood is," write Leunissen and colleagues, adding that the tempo of weight gain might even be more important than the timing.
The group said that the reasons for the increased cardiovascular risk are unknown, but that nutrient-enriched diets that contribute to rapid weight gain might have adverse effects of cardiovascular risk factors later in life. Formula-fed infants, for example, grow at a faster rate than breast-fed infants but are more likely to be overweight later in life. Their study, however, is limited, in that there are no nutritional data available. Future studies need to confirm these findings and to determine which factors determine weight gain, as well as to investigate associations with parental factors, such as genetics and maternal health during pregnancy.
Clinical Implications
Weight gain in the first 3 months of life is linked with reduced insulin sensitivity and serum HDL level and greater waist circumference, acute insulin response, ratio of total cholesterol to HDL cholesterol level, and triglyceride level in early adulthood.
Rapid weight gain in the first 3 months of life is linked with greater body fat percentage and central adiposity and reduced insulin sensitivity in early adulthood.
source: http://cme.medscape.com/viewarticle/704321?sssdmh=dm1.486011&src=nldne
Sunday, June 14, 2009
Excessive Soft Drink Consumption - Avoid
From Reuters Health Information
High Daily Consumption of Cola Soft Drinks Can Cause Hypokalemic Myopathy
NEW YORK (Reuters Health) Jun 05 - Drinking several liters of cola-containing soft drinks per day can cause chronic hypokalemia leading to muscle weakness and even paralysis, according to a review article in the International Journal of Clinical Practice for June.
While one might argue that "excessive soft drink consumption at this level is so rare that it is not a public health issue," the author of an accompanying editorial writes, "the problem is that we have every reason to think that it is not rare."
In a search of PubMed, Dr. Moses Elisaf and associates at the University of Ioannina, Greece, identified six reports of cola-induced hypokalemia published since 1994. Quantities of cola consumed ranged from 2 to 9 liters/day. Muscle complaints ranged from mild weakness to profound paralysis, and all patients had abnormally low serum potassium levels.
"Fortunately," Dr. Elisaf and colleagues write, "all patients had a rapid and complete recovery after the discontinuation of cola ingestion and the oral or intravenous supplementation of potassium."
The authors suggest that one component with the potential to alter potassium metabolism is high-fructose corn syrup, which can cause chronic osmotic diarrhea and potassium depletion. Glucose -- by inducing osmotic diuresis and hyperinsulinemia - or caffeine - by causing potassium redistribution into cells and/or increased renal potassium excretion - may also be responsible.
Dr. Elisaf's team cautions that "the cola-induced chronic hypokalemia clearly predisposes to the development of potentially fatal complications such as cardiac arrhythmias."
In his editorial, Dr. Clifford D. Packer at the Louis Stokes Cleveland VA Medical Center in Cleveland, Ohio, comments that "with aggressive mass marketing, super-sizing of soft drinks, and the effects of caffeine tolerance and dependence, there is very little doubt that tens of millions of people in industrialized countries drink at least 2-3 L of cola per day."
The resulting drop in serum potassium levels increases the risk of cardiac ischemia, heart failure, or left ventricular hypertrophy. He also notes that sugar-sweetened soft drinks have been linked to osteoporosis, gout, GERD, chronic kidney disease, secondary hyperparathyroidism, esophageal perforation, hematuria, tongue erosions, and gastritis.
Dr. Packer advises physicians to start asking their patients about soft drink consumption, and stresses that "the soft drink industry needs to promote safe and moderate use of its products for all age groups, reduce serving sizes, and pay heed to the rising call for healthier drinks."
Int J Clin Pract 2009;63:833-835,900-902.
High Daily Consumption of Cola Soft Drinks Can Cause Hypokalemic Myopathy
NEW YORK (Reuters Health) Jun 05 - Drinking several liters of cola-containing soft drinks per day can cause chronic hypokalemia leading to muscle weakness and even paralysis, according to a review article in the International Journal of Clinical Practice for June.
While one might argue that "excessive soft drink consumption at this level is so rare that it is not a public health issue," the author of an accompanying editorial writes, "the problem is that we have every reason to think that it is not rare."
In a search of PubMed, Dr. Moses Elisaf and associates at the University of Ioannina, Greece, identified six reports of cola-induced hypokalemia published since 1994. Quantities of cola consumed ranged from 2 to 9 liters/day. Muscle complaints ranged from mild weakness to profound paralysis, and all patients had abnormally low serum potassium levels.
"Fortunately," Dr. Elisaf and colleagues write, "all patients had a rapid and complete recovery after the discontinuation of cola ingestion and the oral or intravenous supplementation of potassium."
The authors suggest that one component with the potential to alter potassium metabolism is high-fructose corn syrup, which can cause chronic osmotic diarrhea and potassium depletion. Glucose -- by inducing osmotic diuresis and hyperinsulinemia - or caffeine - by causing potassium redistribution into cells and/or increased renal potassium excretion - may also be responsible.
Dr. Elisaf's team cautions that "the cola-induced chronic hypokalemia clearly predisposes to the development of potentially fatal complications such as cardiac arrhythmias."
In his editorial, Dr. Clifford D. Packer at the Louis Stokes Cleveland VA Medical Center in Cleveland, Ohio, comments that "with aggressive mass marketing, super-sizing of soft drinks, and the effects of caffeine tolerance and dependence, there is very little doubt that tens of millions of people in industrialized countries drink at least 2-3 L of cola per day."
The resulting drop in serum potassium levels increases the risk of cardiac ischemia, heart failure, or left ventricular hypertrophy. He also notes that sugar-sweetened soft drinks have been linked to osteoporosis, gout, GERD, chronic kidney disease, secondary hyperparathyroidism, esophageal perforation, hematuria, tongue erosions, and gastritis.
Dr. Packer advises physicians to start asking their patients about soft drink consumption, and stresses that "the soft drink industry needs to promote safe and moderate use of its products for all age groups, reduce serving sizes, and pay heed to the rising call for healthier drinks."
Int J Clin Pract 2009;63:833-835,900-902.
Thursday, June 11, 2009
Melatonin May Counter Sleep Disorders in Autistic Children
by Jim Kling
June 10, 2009 (Seattle, Washington) — A pilot study in children with autism spectrum disorders (ASD) suggests that low-dose melatonin may be an effective treatment for insomnia in these patients. In this study, positive effects of treatment were seen on both sleep and daytime behavior.
Melatonin "does appear to be effective," Beth Malow, MD, professor of neurology at Vanderbilt University, in Nashville, Tennessee, said during her presentation. She emphasized that the study was small and that more work needs to be done.
"Kids with autism who have some sleep problems are candidates for melatonin, and I believe that large, randomized clinical trials of melatonin are well warranted," she concluded.
Dr. Malow presented the findings here at SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies.
Increasing Melatonin Use
Children with ASD may experience insomnia, the researchers note, and parents are increasingly turning to melatonin as a sleep aid. However, not much is known about its potential adverse effects. Melatonin also comes in a wide variety of formulations, some with additives such as antihistamines or vitamins.
Parents perceive melatonin as a natural treatment, but the wide variety of formulations makes it difficult for practicing physicians to assess its utility. "I don't know what they're taking," said 1 attendee, referring to his autistic patients.
To better assess melatonin's safety and efficacy in autistic children, the researchers conducted a 17-week study of children with ASD who had trouble falling asleep.
The study enrolled children aged 4 to 10 years diagnosed with ASD who required at least 30 minutes to fall asleep on 3 out of 7 nights of the week. Parents received behavioral sleep education before melatonin treatments began, and this was continued through the study. Parents filled out sleep and behavioral survey forms at the beginning and end of all study procedures. Patients wore actigraphy watches (Respironics) for 17 weeks.
After 3 weeks, patients were given 1-mg melatonin (Natrol). Every 3 weeks thereafter, the dose was escalated to 3 mg, 6 mg, and 9 mg, until the patient fell asleep within 30 minutes at least 5 out of 7 nights per week. Pre- and posttreatment actigraphy measures were analyzed using a Wilcoxon signed-ranks test.
Ten patients completed the study with no adverse effects. Three required a dose of 1 mg, 5 required 3 mg, and 2 required 6 mg to achieve the desired end point. No patients required a 9-mg dose.
Patients started with a mean sleep latency of 38.7 minutes that was reduced to a mean of 21.8 minutes with treatment (P = 0.039).
The Children's Sleep Habits Questionnaire showed improvement in sleep-onset delay (P = 0.008) and sleep duration (P = 0.004), repetitive-behavior scale domains of compulsive (P = 0.002) and ritualistic behavior (P = 0.004), and Parent Interview for Autism domain of affective responses (P = 0.02).
Definite Promise
Asked for perspective on these findings, Judith Owens, MD, professor of pediatrics at Brown Medical School, in Providence, Rhode Island, who moderated the session, said the data support the safety, tolerability, and efficacy of melatonin in this patient population.
"This was open label, so you can't get solid conclusions of efficacy, but it definitely has promise," Dr. Owens told Medscape Neurology.
The project was supported by grants from the Autism Speaks/Dana Foundation, the National Institutes of Health, and Vanderbilt University. Melatonin was provided by Natrol. Dr. Malow and Dr. Owens have disclosed no relevant financial relationships.
SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies: Abstract 0189. Presented June 8, 2009.
Jim Kling is a freelance writer for Medscape.
June 10, 2009 (Seattle, Washington) — A pilot study in children with autism spectrum disorders (ASD) suggests that low-dose melatonin may be an effective treatment for insomnia in these patients. In this study, positive effects of treatment were seen on both sleep and daytime behavior.
Melatonin "does appear to be effective," Beth Malow, MD, professor of neurology at Vanderbilt University, in Nashville, Tennessee, said during her presentation. She emphasized that the study was small and that more work needs to be done.
"Kids with autism who have some sleep problems are candidates for melatonin, and I believe that large, randomized clinical trials of melatonin are well warranted," she concluded.
Dr. Malow presented the findings here at SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies.
Increasing Melatonin Use
Children with ASD may experience insomnia, the researchers note, and parents are increasingly turning to melatonin as a sleep aid. However, not much is known about its potential adverse effects. Melatonin also comes in a wide variety of formulations, some with additives such as antihistamines or vitamins.
Parents perceive melatonin as a natural treatment, but the wide variety of formulations makes it difficult for practicing physicians to assess its utility. "I don't know what they're taking," said 1 attendee, referring to his autistic patients.
To better assess melatonin's safety and efficacy in autistic children, the researchers conducted a 17-week study of children with ASD who had trouble falling asleep.
The study enrolled children aged 4 to 10 years diagnosed with ASD who required at least 30 minutes to fall asleep on 3 out of 7 nights of the week. Parents received behavioral sleep education before melatonin treatments began, and this was continued through the study. Parents filled out sleep and behavioral survey forms at the beginning and end of all study procedures. Patients wore actigraphy watches (Respironics) for 17 weeks.
After 3 weeks, patients were given 1-mg melatonin (Natrol). Every 3 weeks thereafter, the dose was escalated to 3 mg, 6 mg, and 9 mg, until the patient fell asleep within 30 minutes at least 5 out of 7 nights per week. Pre- and posttreatment actigraphy measures were analyzed using a Wilcoxon signed-ranks test.
Ten patients completed the study with no adverse effects. Three required a dose of 1 mg, 5 required 3 mg, and 2 required 6 mg to achieve the desired end point. No patients required a 9-mg dose.
Patients started with a mean sleep latency of 38.7 minutes that was reduced to a mean of 21.8 minutes with treatment (P = 0.039).
The Children's Sleep Habits Questionnaire showed improvement in sleep-onset delay (P = 0.008) and sleep duration (P = 0.004), repetitive-behavior scale domains of compulsive (P = 0.002) and ritualistic behavior (P = 0.004), and Parent Interview for Autism domain of affective responses (P = 0.02).
Definite Promise
Asked for perspective on these findings, Judith Owens, MD, professor of pediatrics at Brown Medical School, in Providence, Rhode Island, who moderated the session, said the data support the safety, tolerability, and efficacy of melatonin in this patient population.
"This was open label, so you can't get solid conclusions of efficacy, but it definitely has promise," Dr. Owens told Medscape Neurology.
The project was supported by grants from the Autism Speaks/Dana Foundation, the National Institutes of Health, and Vanderbilt University. Melatonin was provided by Natrol. Dr. Malow and Dr. Owens have disclosed no relevant financial relationships.
SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies: Abstract 0189. Presented June 8, 2009.
Jim Kling is a freelance writer for Medscape.
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