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 October is Children's Health Month
EPA's Office of Children's Health Protection is celebrating Children's Health Month with a series of Webcasts on topics related to healthy school environments.
National Children's Study Federal Advisory Committee Meeting
Date tentative: December 5, 2006
Location: TBD
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The National Children's Study: Building On A History of Longitudinal Studies
Eating well and exercising regularly are basic practices for good health. But before the Framingham Heart Study, launched in 1948, no one knew the extensive role these behaviors played in preventing cardiovascular disease.
 Longitudinal studies like Framingham not only have contributed to our understanding of the causes of serious health conditions, but also have revolutionized how physicians practice medicine and how people care for themselves.
The National Children's Study will be the largest longitudinal child health study ever conducted in the United States. By following 100,000 children from before birth to 21 years of age, Study researchers hope to understand how a variety of factors in one's genes and one's environment influence health.
Several landmark studies have helped pave the way for this research effort, by advancing the science of good health and by providing lessons about good planning and design.
Early Child Health Studies
Three of the earliest U.S. cohort studies of child health and development began during the 1920s and 1930s. The Berkeley Growth Study (1928), Berkeley Guidance Study (1928), and Oakland Growth Study (1932) followed the mental, motor, and physical development of three cohorts of children in Oakland, California.
These three studies helped to establish the field of developmental psychology, and affect how we conduct child cohort studies today. During the Berkeley Growth Study, Field Director Nancy Bayley pioneered the Bayley Scales of Infant Development, a tool that National Children's Study researchers will now use in its updated form to measure the mental health and motor development and test the behaviors of children from 1 to 42 months of age.
After World War II, British investigators began a series of longitudinal cohort studies that have contributed to our current understanding of important factors that affect neurological and behavioral development in childhood. 1Approximately 16,500 women and children participated in the British National Survey of Health and Development (NSHD) beginning in 1946. Considered one of the longest-running studies of human development in the world, the NSHD has influenced British health policy for the last 50 years. 2
In 1959, U.S. scientists began to look at prenatal and other factors that influence a child's growth and development in response to pressing public health problems such as high rates of infant mortality and premature birth. Led by the National Institute of Neurological Diseases and Blindness (now the National Institute of Neurological Disorders and Stroke), the Collaborative Perinatal Project (CPP) tracked more than 40,000 women and children to examine relationships between pregnancy, labor, and delivery with birth outcomes, especially cerebral palsy.
"The CPP taught us that the major causes of cerebral palsy occur earlier in pregnancy than the time of birth and that inflammation of the placenta is a major cause of preterm birth," said Dr. Mark Klebanoff, MD, Director, Division of Epidemiology, Statistics, and Prevention Research, NICHD. "We still use the data decades later. Recent studies using the CPP are looking at whether conception delay is related to low birth weight and how pollutants may impact child development."
National Children's Study researchers have looked to several studies in addition to the CPP to help inform the development of the Study. Lessons learned from the Bogalusa Heart Study in Bogalusa, Louisiana—one of the longest and most detailed multi-ethnic studies of children in the world—have helped Study planners gain key insights into ways to enroll and retain the participation of youth over many years.
National Children's Study planners have also looked to the Study of Health Behavior in School-Aged Children, a cross-sectional national research survey conducted in collaboration with the World Health Organization, for insights into structure and organization of large multicenter studies.
The Role of a National Children's Study
Despite the contributions of these studies, none has examined specifically how a wide range of environmental exposures and one's genetic makeup impact child development over time, nor has any studied a very large nationally representative sample of children from the different racial and socioeconomic backgrounds of the U.S. population.
Like the Framingham Heart Study, the National Children's Study will fill a knowledge gap, and it will do so at a time when rates of obesity, asthma, autism, and other childhood diseases and disorders are on the rise.
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National Children's Study Funding Update
The National Children's Study receives funding from Congress on a yearly basis. In fiscal year 2006, Congressional Appropriations Committee report language included strong support for the Study and its entry into the field, which would include recruitment and full-scale community outreach for fiscal year 2007. However, within his proposed budget for fiscal year 2007, the President did not include funding for the Study and instructed the Study to cease activities as of September 30, 2006.
As in past years, the House and Senate Appropriations Committees have strongly indicated that funding for the Study should continue in fiscal year 2007. Specifically, the House Appropriations bill directs that Study funds should come directly from the National Institute of Child Health and Human Development (NICHD, the Study's home institute). The Senate Appropriations bill proposes that Study funds could be provided through funds from the NIH Office of the Director. Final indication of Congress' intent for the future of the Study is expected to come from the Appropriations Conference Committee this fall, likely after the November elections. Following final approval of the budget and the President's signature, if funds are provided and adequate, the seven operating Vanguard Centers will prepare for recruitment in early 2008 and other Study implementation activities will commence, including awarding of contracts for the remaining 98 sites across the U.S. over the next few years.
While action on the fiscal year 2007 appropriation is in process, Study planners will continue to work toward completion of the protocol, and will work with the Vanguard Centers to establish infrastructure to support the Study, such as developing the information management system and ethics guidelines, and plans for recruitment and retention. Study planners will also continue to update federal and non-federal supporters on the Study's scientific progress. If additional funds are provided in the fiscal year 2007 federal budget, the NICHD will award contracts to more institutions and organizations having the ability to serve as Study Centers.
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James M. Swanson, PhD
The assessment and treatment of attention deficit hyperactivity disorder (ADHD) has been central to Dr. Swanson's career since the mid-1970s. "With the National Children's Study, we have an opportunity to discover why disorders like ADHD are increasingly recognized and treated in the United States," he said.
In September 2005, Dr. Swanson became Principal Investigator of the National Children's Study Vanguard Center for Orange County, California (OCCA). He is Professor of Pediatrics and Director of the University of California, Irvine (UCI) Child Development Center, which is the home for several research and treatment programs for children with ADHD and other disorders of attention, behavior, and learning.
Dr. Swanson and the UCI staff are not strangers to large, long-term, multi-site research studies. They participated in the Multimodal Treatment Study of ADHD and in the Preschool ADHD Treatment Study, both of which were national, six-site randomized clinical trials funded by the National Institute of Mental Health to provide controlled evaluations of established pharmacological and psychosocial treatments for children with ADHD.
"What excited us about the National Children's Study was the ability to look at causes and not just treatments—causes that might have environmental factors operating in combination with genetic factors, causes that potentially are preventable," Dr. Swanson said. "That, and the fact that we have a concentration of great scientists in Orange County with the special interests and expertise needed to make something like this a success."
The OCCA Vanguard Center is based on collaboration between UCI and Children's Hospital of Orange County (CHOC), with participation from many programs in Orange County supported by the Children and Families Commission (CFC) and the Orange County Health Care Agency. Lead investigators include Dean Baker, Pathik Wadhwa, Alison Clarke-Stewart, and Feizal Waffarn from UCI; Leonard Sender, Maria Minon, and Brent Dethlefs from CHOC; Michael Ruane and Alyce Mastrianni from the Children and Families Commission; and Troy Jacobs from the County Health Care Agency.
Members of the OCCA team have considerable experience directing research programs that are very relevant to the first stages of the National Children's Study. For example, Dr. Wadhwa directs a program grant on gene-environment interactions related to stress during pregnancy and Dr. Clarke-Stewart is the Principal Investigator of the UCI site of the NICHD Study of Early Child Care and Youth Development. Dr. Baker directs the UCI Center for Occupational and Environmental Health and has conducted numerous epidemiological studies of environmental factors that affect children's health and development. Dr. Sender directs the cord blood program at CHOC and studies of childhood cancer.
In Orange County, as in other counties across the country, disorders like premature birth, obesity, and asthma are on the rise. The preponderance of freeways presents an opportunity to study the effects of air pollution on the health and development of children. Moreover, the county is the fifth most populous in the United States with 45,000 births every year, half of which are to Hispanic families.
UCI and CHOC have substantial experience providing services to ethnically diverse families. Half of the 800 families per year served by the CHOC-UCI Initiative for the Development of Attention and Readiness program are Hispanic. This CFC-supported program delivers a community-based parent education program in Spanish as well as in English, and provides early intervention for children at risk for attention, learning, or behavior difficulties before they enter elementary school.
Nationally, the OCCA Vanguard Center and the National Children's Study Program Office are planning how families will be chosen to participate in the Study. Statewide, the OCCA Center is identifying scientists at other universities and hospitals to join the California Network for the National Children's Study in order to fill gaps. This network includes a group from the University of California, Riverside, led by Ellen Wartella, which will lend expertise in the assessment of media exposure on child development. The network also includes a group from the University of California, San Diego, led by Ken Lyons Jones and Cristina Chambers, who will lend expertise in the assessment of minor physical anomalies as well as rare, major physical anomalies (birth defects).
In addition, the OCCA Vanguard Center is playing a lead role in the refinement of the genetic components of the National Children's Study. To ensure that the Study is not only state-of-the-art next year but also can meet the scientific challenges looming on the horizon, UCI recently hosted a meeting of leading scientists from across the United States and Canada to address critical issues related to how genes and environments, in combination, affect human development, health, and disease.
"We are overjoyed to be involved in this extraordinary study," said Dr. Swanson. "We can't afford to let this opportunity slip from our grasp."
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In Vitro Fertilization and Adverse Outcomes of Pregnancy
More and more American women are using assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF) to overcome infertility. Two recent studies suggest, however, that IVF is associated with an increased risk of placenta previa—a condition of pregnancy in which the placenta is located in the lower part of the uterus, near to or covering the cervix, thus blocking the baby's exit—and with cerebral palsy (CP) among children. 3, 4
In the first study, published in Human Reproduction (May 2005) Norwegian researchers compared the prevalence of placenta previa in 7,568 pregnancies conceived through IVF with the prevalence of placenta previa in more than 800,000 spontaneously conceived pregnancies. They found a six-fold higher prevalence of placenta previa associated with IVF. In addition, among a subset (n=1,349) of women who had given birth to one baby after IVF and then to another spontaneously, or vice-versa, placenta previa was nearly three times more likely to occur with a woman's IVF pregnancy than with her spontaneously conceived pregnancy.
The second study, a population-based cohort study published in Pediatrics (August 2006) was of 9,255 children conceived through IVF and 394,713 children conceived spontaneously in Denmark. The risk of receiving a CP diagnosis was higher among babies born after IVF: 40 IVF singletons and twins received a CP diagnosis (0.43%), whereas 1,008 non-IVF singletons and twins received a CP diagnosis (0.26%). Further analysis revealed that preterm delivery, particularly for twins but also for singletons, was the key factor affecting the risk of CP after IVF.
The Institute of Medicine (IOM), in a recent report 5, called for guidelines to reduce multiple gestations following infertility treatments, because multiples are more common in assisted reproduction than in spontaneous conception and are more likely to be born at gestational ages of less than 37 weeks. The IOM also called for further investigation into the causes and consequences of preterm delivery after IVF.
The National Children's Study would provide an array of data for such an investigation. National Children's Study researchers plan to collect information on the use of infertility treatments including IVF, multiple gestations, gestational age, birth weight, indicated versus spontaneous preterm birth, perinatal morbidity and mortality, and long-term developmental outcomes. The Study, therefore, has the potential to illuminate the connection between IVF on the one hand and obstetric complications and neonatal outcomes on the other, and to inform efforts to improve infertility treatments and reduce the unintended consequences of these technologies.
1 Landrigan, P.L., Trasande, L., Thorpe, L.E., et al. (in press). The National Children's Study: A 21-year prospective study of 100,000 American children, Pediatrics.
2 Medical Research Council. (2006). The MRC National Survey of Health and Development [Electronic version]. Retrieved on August 31, 2006, from http://www.nshd.mrc.ac.uk/background.html
3 Romundstad, L.B., Romundstad, P.R., Sunde, A., During, V.V., Skjaerven, R., & Vatten, L.J. (2006). Increased risk of placenta previa in pregnancies following IVF/ICSI; a comparison of ART and non-ART pregnancies in the same mother. Human Reproduction, May 25, (epub).
4 Hvidtjorn, D., Grove, J., Schendel, D.E., Vaeth, M., Ernst, E., Nielsen, L.F., & Thorsen, P. (2006). Cerebral palsy among children born after in vitro fertilization: The role of preterm delivery-A population-based, cohort study. Pediatrics, 118, 475–482.
5 Behrman, R.E., & Butler, A.S., Eds. (2006). Preterm birth: Causes, consequences, and prevention. Washington, DC: The Institute of Medicine of the National Academy of Sciences.
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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
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