Growth of Infants Fed an Amino Acid Infant Formula

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01583673
First received: April 20, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Growth
Other: Amino Acid Formula
Other: Amino Acid formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Assessment of Growth of Infants Fed an Amino Acid Based Formula

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Weight Gain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Mean weight gain (g/day) from enrollment to 4 months of age


Secondary Outcome Measures:
  • tolerance [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months.


Enrollment: 225
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 17 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583673

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35244
United States, Illinois
Lutheran General Children's Hospital
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Michigan
Southwestern Medical Clinic
Niles, Michigan, United States, 49120
Southwestern Medical Clinic
Stevensville, Michigan, United States, 49127
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Nebraska
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, United States, 68510
United States, North Carolina
Blue Ridge Pediatric and Adolescent Medicine, Inc.
Boone, North Carolina, United States, 28607
Haywood Pediatric and Adolescent Medicine Group, P.A.
Clyde, North Carolina, United States, 28721
Tarheel Clinical Research
Holly Springs, North Carolina, United States, 27540
United States, Ohio
Ohio Pediatric Research Assn.
Huber Heights, Ohio, United States, 45424
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Hobble Creek Medical Clinic
Springville, Utah, United States, 84663
United States, Virginia
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23223
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Marc Corkins, MD Le Bonheur Children's Hospital
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01583673     History of Changes
Other Study ID Numbers: 09.56.PED
Study First Received: April 20, 2012
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014