Effects of Specific Lipid Fractions-enriched Infant Formulae

Not Applicable

Completed

• Conditions: Infant Growth
• Interventions: Other: Standard infant formula; Other: Standard infant formula with PL1; Other: Standard infant formula with PL2

• Registration Number: NCT02111837
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-09
• Study First Posted: 2014-04-11
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard infant formula	Standard infant formula	Standard infant formula fed ad libitum
Standard infant formula with PL1	Standard infant formula with PL1	Standard infant formula enriched with PL1 lipid fraction fed ad libitum
Standard infant formula with PL2	Standard infant formula with PL2	Standard infant formula enriched with PL2 lipid fraction fed ad libitum

Primary Outcome Measures

Name	Time	Method
Mean weight gain (g/day)	Enrollment to age 4 months

Trial Locations

Locations (4)

CHU de Caen; 🇫🇷 Caen, Cedex 9, France

Hôpital Bretonneau - UPM; 🇫🇷 Tours, Cedex 9, France

Istituto di Ostetricia e Ginecologia Neonatalogia; 🇮🇹 Palermo, Italy

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France