Effects of Specific Lipid Fractions-enriched Infant Formulae

Nestlé

Status

Completed

Conditions

Infant Growth

Treatments

Other: Standard infant formula

Other: Standard infant formula with PL2

Other: Standard infant formula with PL1

Study type

Interventional

Funder types

Industry

Identifiers

NCT02111837

07.16.INF.B

Details and patient eligibility

About

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.

Enrollment

199 patients

Sex

All

Ages

1 to 14 days old

Volunteers

Accepts Healthy Volunteers

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