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Largest U.S. National Children's Study Begins in Jan 2009
By Sue Mueller
Oct 5, 2008 - 1:43:07 PM

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Credit: NIH

The National Institutes of Health announced on Oct 3, 2008 that it will start the National Children's Study in January 2009. The study has been planned since 2004 to determine how genes and environment affect children's health.

The study will follow up 100,000 U.S. children from before birth to age 21. Its completion will cost an estimated $3.1 billion in more than two decades.

The diseases the study will examine include autism, cerebral palsy, learning disabilities, birth defects, attention deficit hyperactivity disorder, diabetes, asthma, heart disease, and obesity among other diseases, the NIH said.

Health officials named 27 study centers covering 39 locations that will be funded in 2008. Together, the total of study centers will be 36 covering 72 study locations.

The study will expand to involve 40 study centers following participants from 105 study locations throughout the United States.

"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."

The study was authorized by Congress in the Children's Health Act of 2004 and has been involving may federal health agencies including the NIH, CDC, EPA, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Environmental Health Sciences.

The 105 locations were determined in 2004. In 2005, the NIH awarded contracted to seven initial or Vanguard centers and in 2007 to 17 additional centers.

Study researchers will recruit participants, collect their genetic, biological, and environmental samples, and compile statistical information for study analyses on the relationships between health, genetics, and the environment.

"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."

The study will start with two initial or so called Vanguard Centers in January in 2009 to carry out a pilot testing for the study. Starting in April 2009, the remaining initial centers will start recruiting participants for the pilot phase of the study. The full-scale recruitment will begin in the summer of 2010.

The study will enroll pregnant women and in some cases women even before pregnancy to identify a range of early life factors that affect later development of diseases.

"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."