Status:
COMPLETED
A New Adaptive Feeding Plan for Newborns
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infant Nutrition
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
Eligibility Criteria
Inclusion
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; \< 42 weeks gestation)
- Birth weight from 2500g to 4500g
- For the formula-fed groups: babies whose mothers elected not to breastfeed at all
- For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
- Newborn whose parents / caregivers can be expected to comply with the protocol
- Study explained and written information given
- Informed consent signed
Exclusion
- Mother who had antibiotics in the 7 days preceding delivery
- Caesarian section
- Multiple birth
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Newborn participating in another clinical trial
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00984230
Start Date
September 1 2009
End Date
February 1 2011
Last Update
June 5 2013
Active Locations (6)
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1
Department of Pediatrics
Vienna, Austria, 1090
2
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, France, 69317
3
Maternité Régionale, Service de Néonatologie
Nancy, France, 54042
4
Service de Néonatologie
Nantes, France, 44093