A New Adaptive Feeding Plan for Newborns

June 4, 2013 updated by: Nestlé

A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Pediatrics
  • France
      • Lyon CEDEX 04, France, 69317
        • Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
      • Nancy, France, 54042
        • Maternité Régionale, Service de Néonatologie
      • Nantes, France, 44093
        • Service de Néonatologie
      • Rouen, France, 76031
        • Hôpital Charles Nicolle, Département de Pédiatrie
  • Greece
    • Athens
      • Palaio Faliro, Athens, Greece, 17562
        • Alexandra Regional General Hospital, Department of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth and gut microbiota
Time Frame: At 1 month and 2 months
At 1 month and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Jean-Charles Pr Picaud, Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.22.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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