Growth and Tolerance of Healthy Term Infants Fed Infant Formula With 100% Whey Protein Hydrolysate or Intact Milk Proteins (Penguin Project)
- Conditions
- growth
- Registration Number
- DRKS00016462
- Lead Sponsor
- Fonterra Co-operative Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 251
•singleton full term birth
•birth weight 2500 to 4500g
•Apgar (any) = 7
•Age 0 to 28 days
•exclusively breast-fed (breastfed reference arm) or formula-fed (formula-fed arms) at enrolment and for at least 90 days thereafter
•informed consent from parents/legal guardians
•adverse maternal, foetal or Infant medical history with effects on growth or feeding tolerance
•maternal gestational diabetes
•allergy to cow´s milk proteins or increased risk of allergy
•rehospitalisation within 5 days of birth
•use of medication that affects gastrointestinal tolerance (incl. antibiotic therapy)
•participation in another clinical trial
•intention to use mixed feeding
•investigators uncertainty about the willingness or ability of the parents to comply with the protocol requirements
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight gain (g/d) over a period of 90 days
- Secondary Outcome Measures
Name Time Method Parameters of growth, feeding tolerance (spitting up, regurgitation, vomiting, flatulence, stool characteristics), digestive comfort (sleeping and crying behavior), adverse events and gut health over a feeding period of 180 days