Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
- Conditions
- Growth
- Registration Number
- NCT01210391
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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 available EHF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight Gain 4 Months Mean weight gain (g/day) from enrollment to 4 months of age.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Colorado Springs Health Partners
🇺🇸Colorado Springs, Colorado, United States
Pedia Research
🇺🇸Owensboro, Kentucky, United States
ARK-LA-Tex Pediatric Research
🇺🇸Bossier City, Louisiana, United States
The Clinical Trials Center
🇺🇸New Orleans, Louisiana, United States
Clinical Research of Nevada
🇺🇸Las Vegas, Nevada, United States
Institute of Clinical Research
🇺🇸Mayfield Heights, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Square-1 Clinical Research
🇺🇸Erie, Pennsylvania, United States
Alpha Clinical Research
🇺🇸Clarksville, Tennessee, United States
Scroll for more (9 remaining)Colorado Springs Health Partners🇺🇸Colorado Springs, Colorado, United States