Study Plan
Enrollment will include three distinct groups: pregnant women and their partners, couples planning pregnancy, and women of child-bearing age but not planning a pregnancy. The National Children's Study will be the first large longitudinal study of children to capture exposures from pre-pregnancy and early pregnancy and to examine outcomes of exposures in the context of a child's genetic makeup.
Families who are enrolled in the Study will participate in a minimum of 15 in-person visits with local Study research teams starting in the first trimester of pregnancy or earlier through 21 years of age. Seven of these visits will be in the participants' homes and eight will be in clinical settings, including the infants' place of delivery. Data will also be remotely collected via telephone, computer, or mail-in questionnaires every three months through the age of five and annually thereafter. Biological samples from the mother and child, as well as air, water, dirt, and dust from the child's environment, will be collected over the course of the Study.
Study Locations
Study locations roughly correspond to U.S. counties or clusters of counties. The locations were selected through a rigorous national probability selection method that ensures that children across the nation are fairly represented in the Study. Eight of these have been designated as potential locations for the first stage of implementation, referred to as Vanguard locations. Based on the availability of funding, three to eight vanguard locations will be launched in 2005, chosen through a competitive process. To learn more about how the locations were selected, see "The National Children's Study: Representing America's Children" on the Study's Web site.
By design, the selected locations are geographically dispersed and demographically varied. By including families from varied backgrounds and family structures, the Study can better investigate issues of vital interest to all communities. Variables for location selection included number of births, demographics, and number of babies born at a low birth weight.
"We believe that the National Children's Study will help us improve the quality of care we give to all of the nation's children. While the National Hispanic Medical Association (NHMA) is particularly concerned about the diseases impacting Latino children, such as diabetes, the Study will help us all better understand how to prevent, diagnose, and treat diseases in all children," said Elena Rios, MD, MSPH, president and chief executive officer, NHMA.
Vanguard Sites and Coordinating Center
The complete Study plan and the request for proposals for institutions to manage potential Vanguard locations can be viewed at https://www.fbo.gov/index?s=opportunity&mode=form&tab= core&id=cfe19bd4fbb6103a19439a8223a4fc75. The request for proposals for the coordinating center can be viewed at https://www.fbo.gov/index?s=opportunity&mode=form&id= 148c5bb34054af7b501a750cc9d582b2&tab=core&_cview=1.
 
Comments or Questions?
E-mail us. Visit our Web site at http://nationalchildrensstudy.gov
The National Children's Study is led by a consortium of federal agency partners:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Centers for Disease Control and Prevention U.S. ENVIRONMENTAL PROTECTION AGENCY |