Infant Growth
Conditions
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.
Interventions
OTHERStandard infant formula with PL1
OTHERStandard infant formula with PL2
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean weight gain (g/day) | Enrollment to age 4 months |
Countries
France, Italy
Outcome results
None listed