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Tuesday, January 13, 2009
National Children’s Study Begins Recruiting Volunteers
The National Institutes of Health announced today that the National Children’s Study will begin recruiting volunteers to take part in its comprehensive study of how genes and the environment interact to affect children’s health. The study will track the health and development of more than 100,000 children from before birth through to their 21st birthday.
At a briefing, NIH officials announced that the first phase of recruitment for the study will begin in Duplin County, N.C., and the New York City borough of Queens.
"The principal benefit of a large scale, long-term study like the National Children’s Study is that it will uncover important health information at virtually every phase of life," said Duane Alexander, M.D., Director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), one of a consortium of federal agencies implementing the study. "Initially, it will provide major insights into disorders of birth and infancy, such as preterm birth and its health consequences. Ultimately it will lead to a greater understanding of adult disorders, many of which are thought to be heavily influenced by early life exposures and events."
Dr. Alexander added that the large size of the study should yield information that smaller and more limited studies cannot. For example, because of the large number of individuals enrolled, the study has the capability to assess uncommon disorders, as well as how exposures to different environmental conditions and genetic factors may interact.
In addition to the NICHD, other members of the consortium carrying out the study are the NIH’s National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency. The National Children’s Study was authorized by Congress in the Children’s Health Act of 2000.
When it is fully operational, the National Children’s Study is expected to have roughly 40 study centers recruiting volunteers from 105 designated study locations throughout the United States. The study locations are counties and clusters of counties chosen by National Children’s Study researchers to be representative of children in the United States.
Of seven initial, or Vanguard, study centers, two will be the first to recruit. This week, the University of North Carolina at Chapel Hill will begin recruiting study volunteers from Duplin County, N.C.. The Mount Sinai School of Medicine in New York City will recruit volunteers from the Borough of Queens.
The centers will hold presentations and other community awareness activities in their respective locations to inform prospective volunteers. Some families in those areas will receive letters introducing the study, explained Peter Scheidt, M.D., M.P.H., director, National Children’s Study. Prenatal care providers and clinics in the study locations will also inform women about the study.
In April of 2009, the remaining five Vanguard centers will also begin recruiting and enrolling women to participate in the study. At the end of 18 months, each center is expected to have recruited a total of approximately 375 volunteers.
A listing of the seven Vanguard center locations is available on the National Children’s Study Web site at http://www.nationalchildrensstudy.gov/about/overview/Pages/Study-Centers-Awarded-12-18-08.pdf.
Dr. Scheidt added that during this initial recruitment phase, referred to as the Vanguard cohort phase, study researchers will evaluate their recruitment and sampling methods.
"We’ll look at what we’ve accomplished, see if our recruitment efforts were sufficient, see if our sampling methods were successful, and if we’ve otherwise asked the right questions to get the information we need," Dr. Scheidt said. "“Along the way, we’ll undertake any fine tuning that we need to in preparation for further enrollment after the Vanguard cohort phase."
The information collected during this Vanguard phase can be pooled with the data collected during later phases of the study to provide the basis for later scientific analysis.
Although the study can be expected to provide information throughout its duration, information on disorders and conditions of early life is expected within the next few years. Because the study will enroll pregnant women and, in some cases, women who are not yet pregnant, study scientists hope to identify a range of early life factors that influence later development.
"It is very exciting to reach the point at which we’re beginning enrollment and data collection,” Dr. Scheidt said. “Findings from the study will ultimately benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments and perhaps even cures for disease."
The two Vanguard Cohort Centers will reflect the study’s representative design in their recruitment, said Dr. Barbara Entwisle, the principal investigator of the National Children’s Study Center at the University of North Carolina at Chapel Hill.
“From city streets to far-flung small towns, the two Vanguard centers will capture a broad sample that’s reflective of America’s diversity,” she said.
Dr. Entwisle explained that, unlike Queens, which is a densely populated urban area, Duplin County is a sparsely populated rural county spread out over a large area — 819 square miles. Many large hog and turkey farms are located in Duplin County, as well as the factories that process them. There are about 800 births per year in Duplin County, a small fraction of the more than 30,000 births that occur in Queens each year, she added.
"The children in the Duplin sample will be representative of other rural areas of the U.S.," Dr. Entwisle said.
The study location in Queens has a population of 2.23 million and is home to thousands of immigrants from more than 100 nations, said Dr. Philip Landrigan, principal investigator, Mount Sinai School of Medicine.
Like many urban counties in the United States, Dr. Landrigan added, Queens is disproportionately affected by many conditions for which the National Children’s Study will help find environmental predecessors and information on the causes. For example, he said, in some parts of New York City, 1 in 4 children have asthma. In addition, one fifth of the city’s children entering kindergarten are overweight.
The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at http://www.nichd.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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