Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

Société des Produits Nestlé (SPN)2 sites in 1 country180 target enrollmentFebruary 2010

ConditionsInfant Nutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Nutrition
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 180
Locations: 2
Primary Endpoint: Mean weight gain
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy newborn infant
•Full-term (\>37 weeks gestation)
•Birth weight between \> 2500 and \< 4500 g
•Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
•Tolerating a cows milk based formula for at least 3 days
•Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
•Informed consent signed (Parent/Legal representative)
•Parent/Caregiver has a working freezer
•Lives within 45 minutes of a study site

Exclusion Criteria

•Congenital illness or malformation that may affect infant feeding and/or normal growth
•Suspected or known allergy to cow's milk protein
•Significant pre-natal and/or post-natal disease
•Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
•Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
•Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
•Infant currently participating in another clinical study
•Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol