NIH’s National Children’s Study Enters Next Phase

Friday, October 3, 2008

Increase In Number of Centers Recruiting Volunteers, Collecting Data

The National Institutes of Health announced today that its comprehensive study to examine the effect of genes and the environment on children’s health had entered the next phase of operations. At a briefing on the latest developments in the National Children’s Study, NIH officials named the study centers funded for 2008.

The study centers are the research institutions that will recruit volunteers for the study. Study centers will recruit from study locations — counties and other geographic demarcations preselected by study scientists to be representative of the United States.

The large size of the study requires that it be carried out in stages. Today, NIH officials named the 27 study centers that will be funded in 2008, which will manage 39 locations. That brings the total of new and existing study centers to 36, covering a total of 72 study locations.

When it is fully operational, the study is expected to have approximately 40 study centers recruiting volunteers from the planned 105 study locations throughout the United States.

The National Children’s Study will follow a representative national sample of 100,000 children from before birth to age 21. The study will investigate factors influencing the development of such conditions as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma, and obesity.

"The advantage of a long term study of development is that it will yield important health information at virtually every phase of the life cycle," said Elias A. Zerhouni, M.D., director of the National Institutes of Health. "Eventually, it will provide greater understanding of adult disorders. In the immediate future, however, we expect it to provide insight into the disorders of birth and infancy."

At the briefing, NIH officials briefly recounted the history of the study. Authorized by Congress in the Children’s Health Act of 2000, the National Children’s Study is being conducted by a consortium of federal agencies. This includes two NIH institutes, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Environmental Health Sciences, as well as the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency.

In 2004, study researchers announced the105 locations throughout the United States from which study participants ultimately will be recruited by the study centers. In 2005, the NIH awarded contracts for seven initial, or Vanguard, Centers, followed by 17 additional centers in 2007.

The study centers will recruit participants, collect genetic, biological, and environmental samples, and compile statistical information for study analyses on the relationships between health, genetics, and the environment. The centers consist of universities, hospitals, health departments, and private companies or represent collaborations between these kinds of organizations. (A table of the 2008 study centers and locations appears below.)

"The National Children’s Study will encompass a nationally representative sample, designed to be a composite of the U.S. population, " said NICHD Director Duane Alexander, M.D. "It will include children throughout the United States, from rural, urban, and suburban areas, from all income and educational levels, and from all racial groups."

Funding for the National Children’s Study is provided each year by Congress. If funding is received as anticipated, and if the necessary technical approvals are obtained, the National Children’s Study is expected to begin initial recruitment at two of the Vanguard Centers in January 2009. This initial recruitment will focus on pilot testing for the study—early phase testing of recruitment procedures and sampling methods—before the full study begins. In April of 2009, the remaining Vanguard Centers will join in enrollment for the pilot phase of the study. After the pilot testing, the first wave of recruitment will begin in the summer of 2010.

Although the study can be expected to provide information throughout its duration, information on disorders and conditions of early life are 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.

"With more than 100,000 participants, we believe the National Children’s Study will be the largest study of pregnant women ever conducted in the United States, " said National Children’s Study Director Peter Scheidt, M.D., M.P.H. "We expect the study to yield information on a variety of pregnancy and birth-associated conditions."

In particular, Dr. Scheidt added, the National Children’s Study could be expected to provide information on the potential contributors to preterm birth. More than 500,000 preterm infants are born each year in the United States. Infants born prematurely are at risk for early death and a variety of health problems, such as cerebral palsy, mental retardation, and learning disabilities. Health care costs for preterm infants total $26 billion per year.

"We expect that what we learn from the National Children’s Study will provide new information that we can use to begin solving the problem of preterm birth, " Dr. Scheidt said. “We are hopeful that we will have this information in just a few years."

Additional information about the National Children’s Study is available from http://www.nationalchildrensstudy.gov.

A chart of the 27 study centers funded for 2008 and their corresponding locations appears at the following link: http://www.nichd.nih.gov/centers2008/.

Source: NIH

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Time Stamp: 10/3/2008 at 4:32:50 PM UTC

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