Infant Feeding and Early Development

The Infant Feeding and Early Development (IFED) study is an observational, longitudinal, prospective cohort study investigating hormonal endpoints during infancy (the Infant Phase) and toddlerhood (the Toddler Phase) in relation to three feeding regimens: (1) breast milk (BF), (2) cow-milk based formula (COW), (3) soy-protein based formula (SOY). The Infant phase was launched at the field site, the Children’s Hospital of Philadelphia (CHOP) in August 2010 and concluded in March 2014.Toddler phase was launched in August 2011 and was closed in April 2013.

The IFED study focused on the natural history of estrogen activity in healthy, full-term infants from birth through the age of 7 months (boys) or 9 months (girls). There were n = 410 mother-infant pairs enrolled; of those, 283 families completed the study (70 BF, 111 COW and 102 SOY) and 6 families (all SOY) completed through the 20 or 24 week visits. Investigators at CHOP recruited, screened, and enrolled mothers into the study during their third trimester of pregnancy or at birth, and collected a sample of mothers’ blood and urine as well as questionnaires for demographics, food intake, and lifestyle activities. At birth, the infant underwent a physical examination, specimen collection, and ultrasonography of specific organs. To document changes in estrogen responsive tissues, the site repeated the physical examination and specimen collections during 9 visits over 7 months in boys and 11 visits over 9 months in girls; ultrasounds were conducted at half of the visits. To ensure infants continued to meet feeding group criteria and remain eligible for participation, mothers were asked about feeding method at each visit throughout the Infant phase.

During the Toddler phase, approximately 195 toddlers were screened, enrolled and completed the assessments at the 12 month visit which included (1) language acquisition with hearing assessment; (2) toy preference; (3) physical exam of breast tissue; (4) bone density.

Levels of endocrine disruptors including as phthalates, BPA, and perchlorate in infant urine have been tested. Data and specimen analyses are ongoing.

Protocol #10-E-N081: Infant Feeding and Early Development