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
• 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

• Growth

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