A New Adaptive Feeding Plan for Newborns

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Other: BSF; Other: BSF + Lactoferrin + Probiotics + OS; Other: BSF + Lactoferrin + Probiotics

• Registration Number: NCT00984230
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basic starter formula: BSF	BSF	-
BSF + Lactoferrin + Probiotics + OS	BSF + Lactoferrin + Probiotics + OS	-
BSF + Lactoferrin + Probiotics	BSF + Lactoferrin + Probiotics	-

Primary Outcome Measures

Name	Time	Method
gut maturation : Specific proteins in stools	3rd day, at 1 week, 2 weeks and 1 month of age

Secondary Outcome Measures

Name	Time	Method
Growth and gut microbiota	At 1 month and 2 months

Trial Locations

Locations (6)

Service de Néonatologie; 🇫🇷 Nantes, France

Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse; 🇫🇷 Lyon CEDEX 04, France

Department of Pediatrics; 🇦🇹 Vienna, Austria

Alexandra Regional General Hospital, Department of Neonatology; 🇬🇷 Palaio Faliro, Athens, Greece

Maternité Régionale, Service de Néonatologie; 🇫🇷 Nancy, France

Hôpital Charles Nicolle, Département de Pédiatrie; 🇫🇷 Rouen, France