Assessment of Growth of Infants Fed a New Formula

Completed · Not applicable

Conditions studied: Infant Nutrition

In brief

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.

Key facts

Study ID

NCT00937014

Run by

Société des Produits Nestlé (SPN)

People needed

180

Starts

2010-02-01

Expected to finish

2013-06-01

Last updated by the study team

2013-06-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pedia Research, LLC — Newburgh, Indiana, United States
• Pedia Research, LLC — Owensboro, Kentucky, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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