Effects of Specific Lipid Fractions-enriched Infant Formulae

April 9, 2014 updated by: Société des Produits Nestlé (SPN)

Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months

This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

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

  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin
    • Cedex 9
      • Caen, Cedex 9, France, 14033
        • CHU de Caen
      • Tours, Cedex 9, France, 37044
        • Hôpital Bretonneau - UPM
  • Italy
      • Palermo, Italy, 90127
        • Istituto di Ostetricia e Ginecologia Neonatalogia

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

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy newborn infant
  • Infant is ≤14 days old on day of enrollment
  • Gestational age ≥37 weeks (full term infants)
  • Birth weight ≥2500 g and ≤4500 g
  • Singleton birth
  • Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria:

  • Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
  • Infant undergoing antibiotic therapy.
  • Re-hospitalization for more than 2 days in the first 14 days of life.
  • Parents not expected to comply with the protocol during the period of study participation.
  • Infants currently participating in another 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
Placebo Comparator: Standard infant formula
Standard infant formula fed ad libitum
Other: Standard infant formula
Experimental: Standard infant formula with PL1
Standard infant formula enriched with PL1 lipid fraction fed ad libitum
Other: Standard infant formula with PL1
Experimental: Standard infant formula with PL2
Standard infant formula enriched with PL2 lipid fraction fed ad libitum
Other: Standard infant formula with PL2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean weight gain (g/day)
Time Frame: Enrollment to age 4 months
Enrollment to age 4 months

Collaborators and Investigators

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

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Claude Billeaud, MD, Hôpital des enfants, CHU Pellegrin, Bordeaux, France

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

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 07.16.INF.B

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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