Growth of Infants Fed an Amino Acid Infant Formula

Completed · Not applicable

Conditions studied: Growth

In brief

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.

Key facts

Study ID

NCT01583673

Run by

Société des Produits Nestlé (SPN)

People needed

225

Starts

2012-05-01

Expected to finish

2013-07-01

Last updated by the study team

2015-10-21

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics/Southlake Pediatrics — Birmingham, Alabama, United States
• Clinical Research Consortium Arizona — Phoenix, Arizona, United States
• Lutheran General Children's Hospital — Park Ridge, Illinois, United States
• Nassim, MCMonigle, Mescia and Associates — New Albany, Indiana, United States
• Bluegrass Clinical Research, Inc. — Louisville, Kentucky, United States
• Southwestern Medical Clinic — Niles, Michigan, United States
• Southwestern Medical Clinic — Stevensville, Michigan, United States
• Women's Clinic of Lincoln, P.C. — Lincoln, Nebraska, United States
• Blue Ridge Pediatric and Adolescent Medicine, Inc. — Boone, North Carolina, United States
• Haywood Pediatric and Adolescent Medicine Group, P.A. — Clyde, North Carolina, United States
• Tarheel Clinical Research — Raleigh, North Carolina, United States
• Ohio Pediatric Research Assn. — Dayton, Ohio, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Jean Brown Research — Salt Lake City, Utah, United States
• Clinical Research Specialists of Utah, Inc — Spanish Fork, Utah, United States

Full record on ClinicalTrials.gov

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