Growth of Infants Fed an Amino Acid Infant Formula

Assessment of Growth of Infants Fed an Amino Acid Based Formula

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.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: Amino Acid Formula; Other: Amino Acid formula

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics
    • Birmingham, Alabama, United States, 35244
      • Alabama Clinical Therapeutics/Southlake Pediatrics
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Clinical Research Consortium Arizona
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General Children's Hospital
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Nassim, MCMonigle, Mescia and Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Bluegrass Clinical Research, Inc.
  • Michigan
    • Niles, Michigan, United States, 49120
      • Southwestern Medical Clinic
    • Stevensville, Michigan, United States, 49127
      • Southwestern Medical Clinic
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, P.C.
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Blue Ridge Pediatric and Adolescent Medicine, Inc.
    • Clyde, North Carolina, United States, 28721
      • Haywood Pediatric and Adolescent Medicine Group, P.A.
    • Raleigh, North Carolina, United States, 27612
      • Tarheel Clinical Research
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Assn.
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
    • Spanish Fork, Utah, United States, 84660
      • Clinical Research Specialists of Utah, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amino Acid Formula; Hypoallergenic baby formula	Other: Amino Acid Formula; Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Active Comparator: Amino Acid commercial formula; Hypoallergenic commercial amino acid formula	Other: Amino Acid formula; Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain	Mean weight gain (g/day) from enrollment to 4 months of age	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerance	Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months.	4 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Marc Corkins, MD, Le Bonheur Children's Hospital

Publications and helpful links

General Publications

• Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 09.56.PED