Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
- Conditions
- Growth
- Interventions
- Other: Extensively hydrolyzed whey infant formulaOther: Extensively hydrolyzed casein infant formula
- 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
- Arm && Interventions
Group Intervention Description New hydrolyzed infant formula Extensively hydrolyzed whey infant formula New, extensively hydrolyzed infant formula Commercially available infant formula Extensively hydrolyzed casein infant formula Commercially available, extensively hydrolyzed infant formula.
- 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)
The Clinical Trials Center
🇺🇸New Orleans, Louisiana, United States
Pedia Research
🇺🇸Owensboro, Kentucky, United States
Colorado Springs Health Partners
🇺🇸Colorado Springs, Colorado, United States
ARK-LA-Tex Pediatric Research
🇺🇸Bossier City, 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
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Southwest Children's Research Associates
🇺🇸San Antonio, Texas, United States
DCOL Center for Research
🇺🇸Longview, Texas, United States
Scott & White Temple
🇺🇸Temple, Texas, United States
Scott & White Wells Branch Clinic
🇺🇸Austin, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Clinical Research Partners
🇺🇸Richmond, Virginia, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Scott & White Killeen Clinic
🇺🇸Killeen, Texas, United States