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

Société des Produits Nestlé (SPN)4 sites in 2 countries199 target enrollmentNovember 2009

ConditionsInfant Growth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Growth
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 199
Locations: 4
Primary Endpoint: Mean weight gain (g/day)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

December 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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