2.1. Design and Participants
private-practice
CHRONIC DISEASES, PROTEIN ALLERGY
This trial was a double-blind RCT with two-arm parallel assignment conducted at six pediatrician’s offices in the greater Paris area of France. An independent ethics committee approved the study protocol (CPP Sud Méditerranée 3, France; ref.: 2018.01.01), which complied with the Declaration of Helsinki. Both legal representatives of each patient provided their written informed consent before inclusion. The study was registered prospectively at ClinicalTrials.gov (NCT03488758).Eligible patients were healthy infants ≤4 months old who were predominantly formula fed and followed by a private-practice pediatrician. Patients were ineligible if born at a gestational age of <37 weeks, had a confirmed or suspected cow’s milk protein allergy, were predominantly breastfed (≥50% of feeding volume), or suffered from chronic diseases.At trial initiation, participants were randomly assigned to the GMF or CMF groups at a 1:1 ratio, applying a double-blind procedure. After checking inclusion/exclusion criteria, the investigators explained the study to the legal representatives at the screening visit. The clinical and demographic characteristics, and relevant medical and maternal history, of participating individuals were recorded at the inclusion visit (baseline), which took place 1 to 5 days before milk delivery. Outcome ascertainment and collection of safety assessment data were performed at trial centers during the inclusion visit and the final visit (day 28 ± 3 after milk delivery). Participants’ parents were contacted via phone on day 14 ± 3 to verify compliance and safety assessments. Compliance at days 14 and 28 was defined as having maintained exclusive bottle feeding (with or without additional breastfeeding) with the study formula delivered.