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NCT01583673 Clinical Trial

Growth of Infants Fed an Amino Acid Infant Formula

Growth Clinical Trial

Official title:
Assessment of Growth of Infants Fed an Amino Acid Based Formula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01583673
Other study ID # 09.56.PED
Secondary ID
Status Completed
Phase N/A
First received April 20, 2012
Last updated October 20, 2015
Start date May 2012
Est. completion date July 2013

Study information
Verified date June 2014
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 17 Days
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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
• 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

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

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight Gain Mean weight gain (g/day) from enrollment to 4 months of age 4 months No
Secondary tolerance Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months. 4 months Yes
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Completed NCT01210391 - Growth of Infants Fed an Extensively Hydrolyzed Infant Formula N/A
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