growth
Conditions
Interventions
Group 1: Infants will be exclusively fed infants starter formula with partially-hydrolised protein (WPH 7051) over a feeding period of al least 90 days
Group 2: Infants will be exclusively fed a Stand
Sponsors
Fonterra Co-operative Group Limited
Eligibility
Sex/Gender
All
Age
No minimum to 28 Days
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Primary
| Measure | Time frame |
|---|---|
| Weight gain (g/d) over a period of 90 days | — |
Countries
Bulgaria, Germany
Contacts
Public ContactAntonia Nomayo
Evangelisches Waldkrankenhaus Spandau
Outcome results
None listed