Status:
COMPLETED
Assessment of Growth of Infants Fed a New Formula
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infant Nutrition
Eligibility:
All Genders
11-17 years
Phase:
NA
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 mont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00937014
Start Date
February 1 2010
End Date
June 1 2013
Last Update
June 26 2013
Active Locations (3)
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1
Pedia Research, LLC
Newburgh, Indiana, United States, 47630
2
Pedia Research, LLC
Owensboro, Kentucky, United States, 42301
3
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201