Status:
COMPLETED
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Growth
Eligibility:
All Genders
11-4 years
Phase:
NA
Brief Summary
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially...
Eligibility Criteria
Inclusion
- Healthy newborn singleton infant
- Full-term (\>= 37 weeks gestation)
- Birth weight between \>= 2500 and \< =4500 g
- 14 ± 3 days of age on enrollment
- Infant's mother has elected not to breastfeed
- baby has been exclusively formula fed a minimum of 3 days prior to enrollment
- Study explained and written information provided with Parent/Caregiver
- Informed consent signed (parent/legal representative)
Exclusion
- Congenital illness or malformation affecting infant feeding and/or 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 IV antibiotic therapy in the 10 days prior to enrollment
- Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- Infant has received probiotics in the seven days prior to enrollment
- 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 :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT01210391
Start Date
November 1 2010
End Date
July 1 2013
Last Update
June 26 2014
Active Locations (20)
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1
Colorado Springs Health Partners
Colorado Springs, Colorado, United States
2
Pedia Research
Newburgh, Indiana, United States, 42301
3
Pedia Research
Owensboro, Kentucky, United States, 42301
4
ARK-LA-Tex Pediatric Research
Bossier City, Louisiana, United States