Children's study closes site here after rethinking

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The National Children's Study was designed to be the largest ever long-term study of the health of children in the United States.

Its purpose was to determine how genetics and environment affected birth defects, autism, asthma, diabetes, heart disease, obesity and other child health problems, by following subjects from the prenatal stages to age 21.

Now all of the study's 40 sites across the country, including one in Westmoreland County run by researchers from the University of Pittsburgh, are shutting down due to a rethinking of the study's entire design -- not to mention its cost, which is approaching $1 billion nationally.

At the end of March, the work will fall to a large contractor out of Chicago.

"We're in the process of shutting down," said Jane A. Cauley, principal investigator and an epidemiologist at the Pitt Graduate School of Public Health. The dozen researchers hired from Westmoreland County are looking for jobs or have already left, she said, and the six investigators from Pitt will be moving on to other projects.

The Westmoreland County site was established with a contract beginning in 2007.

The site had enrolled 150 families with pregnant women over the past 14 months, first going door-to-door in designated areas to gather a representative sample and then using a direct marketing approach. Researchers visited the families to collect cord blood, vacuum cleaner bags and water samples. Samples were processed at a lab set up in the community, with duplicate freezers, centrifuges and other equipment to avoid cross-contamination.

The site also had recruited another 200 women who were planning to get pregnant in the near future. That would have given the site 350 children and families to follow over the next two decades and beyond. The budget ranged from $1.5 million to $2 million a year.

"We were supposed to follow them for 21 years," Ms. Cauley said. "That's what we told them when we recruited them. Obviously that's not going to happen now. I feel bad that we can't keep that promise."

A new contractor, however, will continue the work.

The National Children's Study grew out of a request by Congress to the National Institutes of Health in 2000 to examine a range of influences on children's health, from chemicals and other contaminants to schooling and television. The original goal was to study 100,000 children, with an estimated price tag of $2.7 billion over 25 years.

Eventually the study grew to encompass 40 centers run by university researchers in 105 counties across the country. By last year the centers had recruited about 4,000 women for an initial random sample.

But the progress was too slow and too costly, in the view of the National Institute of Child Health and Human Development, the NIH division in charge of the study, which concluded that the effort had ballooned out of control. So NIH hit the reboot button.

The study will continue -- new recruitment will begin in 2014 -- but under very different parameters.

Instead of scattered sites attached to numerous academic institutions, four large contractors will be taking over the work (Westmoreland's will be assumed by the NORC, which specializes in social science research and is affiliated with the University of Chicago). The goal there is improved efficiency and reduced cost.

Instead of door-to-door recruitment of pregnant women so that prenatal influences can be documented, much of the recruitment will take place at hospitals with newborn babies. If those families have a subsequent pregnancy, prenatal study would be pursued. This is designed to speed up enrollment.

And instead of working from a set of 28 core hypotheses (Is there a link between violent video games and gun injuries? Are some children genetically more sensitive to pesticides than others?), the new study will build "a data platform" that will be hypothesis-free.

This last point especially troubles Ms. Cauley and many of her academic colleagues.

"Without hypotheses, you can't prioritize data collection," she said. "If you're asking about asthma, you make sure you have the environmental exposure information that will help you find answers. Otherwise how do you know what data the study should collect?"

The team will be talking to the community advisory board next week about the shutdown, Ms. Cauley said, and then mailing letters to enrolled families explaining the changes and introducing the new contractor. All of the lab equipment has been sent to other labs in the region.

"We had great partners in the Westmoreland County community and I feel positive about what we did there," she said.

"It's a very important study. I hope if the new design goes forward without hypotheses, it can still address the original goals."


Correction/Clarification: (Published February 6, 2013) NORC at the University of Chicago is the contractor taking over work on the National Children's Study from the University of Pittsburgh site in Westmoreland County. An earlier version of this story about changes in the study referred to it as the National Opinion Research Center, the contractor's former name.
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Sally Kalson: skalson@post-gazette.com or 412-263-1610.


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