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