The National Institutes for Health-led study will follow 100,000 kids from before birth until they turn 21. And 1000 of those children will come from Jefferson County, now that the University of Louisville’s school of public health has been chosen as a study site. Here, researchers will recruit pregnant women or women who plan to become pregnant. Dr. David Tollerud heads the environmental and occupational health sciences program at U of L’s school of public health. He says they’ll use census data to make sure they’re targeting a representative sample of the county’s racial and socio-economic make-up.
“It won’t be the sort of study where we’ll run a radio ad and say if you’re interested in participating in this, call this number. It’ll be much more of the researchers approaching individual neighborhoods, individual blocks, individual homes to participate,” Tollerud says.
Tollerud says this complex and labor-intensive study aims to draw conclusions about the links between genetics and environmental factors on a child’s health and development. Eventually, participants will be enrolled at 105 sites around the country. In each, researchers will visit pregnant mothers in the home and accompany them on an ultrasound visit. They’ll take blood samples, do phone interviews. When the child is born they’ll take more blood and tissue samples. And they’ll follow the child’s early development closely, visiting every 6 months or so. U of L pediatrics professor Deborah Davis says that, to gather all the data, they’ll need hundreds of fieldworkers.
“We’ll be bringing on people and providing all the specific training necessary to get everyone reliable and to make sure everyone’s collecting the data in a consistent and scientific manor. So it’s going to be very labor intensive and we’ll have lots of people who are going to be hired for those purposes,” Davis says.
National Children’s Study director Dr. Peter Scheidt says another small army of researchers will gather environmental samples in homes.
“We’ll be able to collect air samples, water, dust, soil, where infants are playing and so on, as well as the important biological samples, blood and tissue,” says Scheidt.
Scheidt says such a large and complex study is required because children live in complex environments. Simply linking one kind of exposure to one kind of health problem wouldn’t tell the whole story.
“The ability to be able to measure interactions between classes of exposures and genetic factors requires very large sample sizes, it requires collecting the multiple kinds of exposures and genetic factors, psycho-social factors, all in the same individual, and following them long enough to see the outcomes,” Scheidt says.
All of this data will be sent directly to federal labs for analysis. And the NIH has placed strict controls on how it will be handled to protect participants’ privacy. But U of L’s Dr. David Tollerud says the NIH will allow local study centers to ask for local data sets. Tollerud says that is particularly enticing in a place where environmental factors have long been suspected of causing health problems.
“We have ideas in our head about things we would really like to know more about, the metro Louisville community, Jefferson county. But there are some other ideas we know are very common in the Midwest. We could name five other counties or more that have very similar problems where we might get together and team up and say hey, let’s do a little study much more focused on our own community’s problems,” says Tollerud.
Recruiting for the study won’t begin for another year and a half. But researchers hope to have preliminary data about pregnancy outcomes at the study sites within five to six years.