National children's study moves forward, enrolls participants

The massive National Children's Study, which has survived a change in leadership and a gauntlet of criticism about its methods and its costs, has the full support of the National Institutes of Health director Francis Collins, MD, PhD, according to discussions at the study's October federal advisory committee meeting.

However, the study is still struggling with some basic issues.

Researchers plan to follow 100,000 children from before birth to age 21 years to examine the effects of environmental influences. It is expected to be the largest long study on the subject undertaken in the United States.

At the October meeting, some committee members voiced concern, for example, about the study design as it has been changed because it is not driven by specific hypotheses. Rather, it is aimed at collecting the most important information on which many different studies could be based.

Ad hoc committee participant Ellen Silbergeld, PhD, a well-known environmental researcher, said it was "extremely baffling how one would go about making decisions or prioritizations" for the study without hypotheses about the effects of particular elements.

Acting study director Steven Hirschfeld, MD, PhD, said that the work is now "reoriented to say that we are going to be interested in particular domains," but the researchers will not initially ask specific questions about what causes particular effects.

"So, it is going to be driven by what is feasible for us to collect, what's affordable for us to collect, what's meaningful, and then how can we cross walk the data we collect with other data," he said.

Alan Guttmacher, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said that the effort could be "hypotheses-informed," but it is basically "a data platform. A resource for trying to make sure that we, in as efficient and effective manner as possible, gather the data points which only a study like this could do, that will be of use for the research community for decades to come. . . . If this works as well as we hope it [will], people will be using it to look at hypotheses 15 to 20 years from now that we should not [have been] even able to imagine today."

The study's funding has increased from $69 million in 2007 to "up to" $193.8 million in 2010.

In September, the staff announced that it had initiated recruitment of women who are pregnant or attempting to become pregnant in 30 new sites around the country in addition to the 7 locations where the work began earlier.