Effects of Specific Lipid Fractions-enriched Infant Formulae

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.

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Key information

Conditions

Infant Growth

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen, Caen, Cedex 9, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Infant Formula

Other

Standard infant formula with PL1

Other

Standard infant formula with PL2

Other

Primary outcomes

Mean weight gain (g/day)

Time frame: Enrollment to age 4 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Apr 11, 2014
Registry last updated: Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed