|National Children’s Study Begins Recruiting
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
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
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
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
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/.
The National Institutes of Health (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.
It is the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit www.nih.gov.