Assessment of Growth of Infants Fed a New Formula

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Other: standard infant formula; Other: Test formula

• Registration Number: NCT00937014
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Study Start: 2010-02
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard infant formula	standard infant formula	-
Test formula	Test formula	-

Primary Outcome Measures

Name	Time	Method
Mean weight gain	4 months

Secondary Outcome Measures

Name	Time	Method
anthropometry, tolerance, morbidity, blood tests	9 months

Trial Locations

Locations (2)

Pedia Research, LLC; 🇺🇸 Owensboro, Kentucky, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States