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Effects of Specific Lipid Fractions-enriched Infant Formulae

Not Applicable
Completed
Conditions
Infant Growth
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

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
Primary Outcome Measures
NameTimeMethod
Mean weight gain (g/day)Enrollment to age 4 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

CHU de Caen

🇫🇷

Caen, Cedex 9, France

Hôpital Bretonneau - UPM

🇫🇷

Tours, Cedex 9, France

Groupe Hospitalier Pellegrin

🇫🇷

Bordeaux, France

Istituto di Ostetricia e Ginecologia Neonatalogia

🇮🇹

Palermo, Italy

CHU de Caen
🇫🇷Caen, Cedex 9, France

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