NCT01210391.

Trial name or title	Growth of infants fed an extensively hydrolyzed infant formula
Methods	Randomised controlled trial.
Participants	n = 282 Inclusion criteria Healthy newborn singleton infant. Full term (≥ 37 weeks' gestation). Birth weight between ≥ 2500 g and ≤ 4500 g. 14 ± 3 days of age on enrolment. Infant's mother elected not to breast feed. Baby exclusively formula fed a minimum of 3 days before enrolment. Study explained and written information provided to parent/caregiver. Informed consent signed (parent/legal representative). Exclusion criteria Congenital illness or malformation affecting infant feeding and/or growth. Suspected or known allergy to cow's milk protein. Significant prenatal and/or postnatal disease. Any readmission to hospital (except for hyperbilirubinaemia) before enrolment. Infant receiving oral or IV antibiotic therapy in the 10 days before enrolment. Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequently using over‐the‐counter medications except vitamin and mineral supplements. Infant receiving probiotics in the 7 days before enrolment. Infant currently participating in another clinical study. Infant's family in the Investigator's assessment cannot be expected to comply with the protocol.
Interventions	Extensively hydrolysed whey infant formula vs extensively hydrolysed casein infant formula.
Outcomes	Weight gain to 4 months. Mean weight gain (grams/d) from enrolment to 4 months of age.
Starting date	November 2010; study completion date: July 2013.
Contact information	Ricardo Sorensen, MD, Louisiana State University Health Sciences Center in New Orleans.
Notes	ClinicalTrials.gov Identifier: NCT01210391