Growth of Infants Fed an Amino Acid Infant Formula

Not Applicable

Completed

• Conditions: Growth

• 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

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Study Start: 2012-05
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-06
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

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)

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; 🇺🇸 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

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