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Growth of Infants Fed an Amino Acid Infant Formula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583673
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Growth Other: Amino Acid Formula Other: Amino Acid formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Assessment of Growth of Infants Fed an Amino Acid Based Formula
Study Start Date : May 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Weight Gain [ Time Frame: 4 months ]
    Mean weight gain (g/day) from enrollment to 4 months of age

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583673

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United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35205
Alabama Clinical Therapeutics/Southlake Pediatrics
Birmingham, Alabama, United States, 35244
United States, Arizona
Clinical Research Consortium Arizona
Phoenix, Arizona, United States, 85004
United States, Illinois
Lutheran General Children's Hospital
Park Ridge, Illinois, United States, 60068
United States, Indiana
Nassim, MCMonigle, Mescia and Associates
New Albany, Indiana, United States, 47150
United States, Kentucky
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
United States, Michigan
Southwestern Medical Clinic
Niles, Michigan, United States, 49120
Southwestern Medical Clinic
Stevensville, Michigan, United States, 49127
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
Raleigh, North Carolina, United States, 27612
United States, Ohio
Ohio Pediatric Research Assn.
Dayton, Ohio, United States, 45414
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
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Clinical Research Specialists of Utah, Inc
Spanish Fork, Utah, United States, 84660
Sponsors and Collaborators
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Principal Investigator: Marc Corkins, MD Le Bonheur Children's Hospital

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Responsible Party: Nestlé Identifier: NCT01583673     History of Changes
Other Study ID Numbers: 09.56.PED
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: June 2014