Effects of Specific Lipid Fractions-enriched Infant Formulae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Infant Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard infant formula

Standard infant formula fed ad libitum

Group Type PLACEBO_COMPARATOR

Standard infant formula

Intervention Type OTHER

Standard infant formula with PL1

Standard infant formula enriched with PL1 lipid fraction fed ad libitum

Group Type EXPERIMENTAL

Standard infant formula with PL1

Intervention Type OTHER

Standard infant formula with PL2

Standard infant formula enriched with PL2 lipid fraction fed ad libitum

Group Type EXPERIMENTAL

Standard infant formula with PL2

Intervention Type OTHER

Interventions

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Standard infant formula

Intervention Type OTHER

Standard infant formula with PL1

Intervention Type OTHER

Standard infant formula with PL2

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes