Study of Estrogen and Development
Social & Scientific Systems served as the coordinating center for a cross-sectional clinical NIEHS pilot study investigating the natural history of estrogen-sensitive tissue in 600 infants (ages 0-12 months) who were fed breastmilk, soy formula, or cows'-milk formula. Investigations included ultrasonography of estrogen-sensitive tissue, physical Ballard-type examination, and collection of biologic specimens. We wrote a request for proposal (RFP) soliciting proposals for the three separate substudies and negotiated subcontracts with Children's Hospital of Philadelphia (CHOP) and The Children's Hospital (TCH) of Boston. We coordinated the development of recruitment and collections protocols with the sites in preparation for a larger, comprehensive trial of biological response to soy formula in children. We hosted an initial investigators' meeting and subsequently helped NIEHS assemble a Data Safety Monitoring Board (DSMB). We also coordinated DSMB meetings and site visits. We developed all study materials, protocols, and NIEHS IRB submissions; coordinated IRB submissions at CHOP and Harvard; and trained staff at the two sites. A Web-based, secure tracking system was developed at Social & Scientific Systems for the CHOP and TCH sites to enter enrollment, visit schedules, and complete data and specimen collections. Via the Web site, NIEHS investigators and our staff accessed and monitored real-time participant accrual. We also developed procedural manuals and specimen collection protocols used at the two sites.
In 2005, design work began for SEAD 4, a longitudinal study to follow 420 mother-infant pairs equally divided between three feeding groups—breastfed, soy formula fed, or cow formula fed. Mothers will be enrolled in their third trimester, and babies will be followed from birth to 2 years. Participation will involve the collection of nutrition and feeding practices data, sonographic and physical examinations, and collection of biologic specimens. The decision of which specimens to collect will be based on analysis of the first three SEAD studies. We will act as the coordinating center for this study involving multiple hospital sites, estimated to operate for 5 years. In year 1, RFPs will be developed and released for competition. We will develop the protocols and conduct training.