Growth of Infants Fed an Amino Acid Infant Formula
- Conditions
- Growth
- Interventions
- Other: Amino Acid formula
- Registration Number
- NCT01583673
- 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 Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- Healthy newborn infant
- Full-term (>= 37 weeks gestation)
- Birth weight between >= 2500 and < =4500 g
- 0-17 days of age on enrolment (day 0 is day of birth)
- Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
- Study explained and written information provided with Caregiver demonstrating understanding of the given information
- Informed consent signed (parent/legal representative)
- 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 enrolment
- 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 currently participating in another conflicting 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 Amino Acid Formula Amino Acid formula Hypoallergenic baby formula Amino Acid commercial formula Amino Acid formula Hypoallergenic commercial amino acid 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 tolerance 4 months Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months.
Trial Locations
- Locations (16)
Nassim, MCMonigle, Mescia and Associates
🇺🇸New Albany, Indiana, United States
Lutheran General Children's Hospital
🇺🇸Park Ridge, Illinois, United States
Bluegrass Clinical Research, Inc.
🇺🇸Louisville, Kentucky, United States
Blue Ridge Pediatric and Adolescent Medicine, Inc.
🇺🇸Boone, North Carolina, United States
Women's Clinic of Lincoln, P.C.
🇺🇸Lincoln, Nebraska, United States
Haywood Pediatric and Adolescent Medicine Group, P.A.
🇺🇸Clyde, North Carolina, United States
Tarheel Clinical Research
🇺🇸Raleigh, North Carolina, United States
Institute of Clinical Research
🇺🇸Mayfield Heights, Ohio, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Southwestern Medical Clinic
🇺🇸Stevensville, Michigan, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics/Southlake Pediatrics
🇺🇸Birmingham, Alabama, United States
Clinical Research Consortium Arizona
🇺🇸Phoenix, Arizona, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Clinical Research Specialists of Utah, Inc
🇺🇸Spanish Fork, Utah, United States
Ohio Pediatric Research Assn.
🇺🇸Dayton, Ohio, United States