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A New Adaptive Feeding Plan for Newborns

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00984230
First received: September 10, 2009
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Infant Nutrition
 Other: BSF
Other: BSF + Lactoferrin + Probiotics
Other: BSF + Lactoferrin + Probiotics + OS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • gut maturation : Specific proteins in stools [ Time Frame: 3rd day, at 1 week, 2 weeks and 1 month of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Growth and gut microbiota [ Time Frame: At 1 month and 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 186
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Breastfeeding (Reference)
Active Comparator: Basic starter formula: BSF Other: BSF
feeding amount according to individual baby need
Experimental: BSF + Lactoferrin + Probiotics + OS Other: BSF + Lactoferrin + Probiotics + OS
feeding amount according to individual baby need
Experimental: BSF + Lactoferrin + Probiotics Other: BSF + Lactoferrin + Probiotics
feeding amount according to individual baby need

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984230

Locations
Austria
Department of Pediatrics
Vienna, Austria, 1090
France
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon CEDEX 04, France, 69317
Maternité Régionale, Service de Néonatologie
Nancy, France, 54042
Service de Néonatologie
Nantes, France, 44093
Hôpital Charles Nicolle, Département de Pédiatrie
Rouen, France, 76031
Greece
Alexandra Regional General Hospital, Department of Neonatology
Palaio Faliro, Athens, Greece, 17562
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Jean-Charles Pr Picaud Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00984230     History of Changes
Other Study ID Numbers: 07.22.INF
Study First Received: September 10, 2009
Last Updated: April 24, 2012
Health Authority: France: Comité de Protection des Personnes

Keywords provided by Nestlé:
Infant Formula
Gut

ClinicalTrials.gov processed this record on May 16, 2013