Assessment of Growth of Infants Fed a New Formula

Nestlé

Status

Completed

Conditions

Infant Nutrition

Treatments

Other: standard infant formula

Other: Test formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT00937014

07.35.INF

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

11 to 17 days old

Volunteers

Accepts Healthy Volunteers

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