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Growth of Infants Fed an Amino Acid Infant Formula

This study is currently recruiting participants.
Verified January 2013 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01583673
First received: April 20, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 180
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583673

Contacts
Contact: Therese Voss 973 593 7779 terri.voss@rd.nestle.com

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC Recruiting
Birmingham, Alabama, United States, 35244
Contact: Zona Till, Dr.     205-914-2062     zona.till@medsearchrx.com    
Principal Investigator: Edward Goldblatt, MD            
United States, Illinois
Lutheran General Children's Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Sandy Maki, Dr.     847-723-7570     sandy.maki@advocatehealth.com    
Principal Investigator: Christopher Jamerson, MD            
United States, Kentucky
Bluegrass Clinical Research, Inc. Recruiting
Louisville, Kentucky, United States, 40291
Contact: Pamela Rogers, Dr.     502-231-1982     bcr@bellsouth.net    
Principal Investigator: Wendy Daly, MD            
Bluegrass Clinical Research, Inc. Recruiting
Louisville, Kentucky, United States, 40291
Contact: Jennifer Leonard, Dr.     502-231-1982     bcr@bellsouth.net    
Principal Investigator: Cynthia Nassim, MD            
United States, Louisiana
Children's Hospital of New Orleans Not yet recruiting
New Orleans, Louisiana, United States, 70118
Contact: Ricardo Sorensen, MD     504-896-2723     rsoren@lsuhsc.edu    
Principal Investigator: Ricardo Sorensen, MD            
United States, Michigan
Southwestern Medical Clinic Recruiting
Niles, Michigan, United States, 49120
Contact: Jean Sullivan, Dr.     269-687-0200 ext 1634     jsullivan@swmc.org    
Principal Investigator: Lois Lello, Dr.            
Southwestern Medical Clinic Recruiting
Stevensville, Michigan, United States, 49127
Contact: Kelly McDannel, Dr.     269-932-1026     kmcdannel@swmc.org    
Principal Investigator: Richard Hines, MD            
United States, Missouri
The Center for Pharmaceutical Research Recruiting
Kansas City, Missouri, United States, 64114
Contact: John Ervin, MD     816-943-0770     newstudy@cprkc.com    
Principal Investigator: John Ervin, MD            
United States, Nebraska
Women's Clinic of Lincoln, P.C. Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Nancy Kube, Dr.     402-441-0025     nkubewc@neb.rr.com    
Principal Investigator: Svjetlana Dziko, MD            
United States, North Carolina
Blue Ridge Pediatric and Adolescent Medicine, Inc. Recruiting
Boone, North Carolina, United States, 28607
Contact: Merina Church, Dr.     828-262-0100     mchurch@blueridgepeds.com    
Principal Investigator: Gregory Adams, Dr.            
Haywood Pediatric and Adolescent Medicine Group, P.A. Recruiting
Clyde, North Carolina, United States, 28721
Contact: Gloria Justice, Dr.     828-452-2211 ext 11     gjustice@haywoodpediatrics.com    
Principal Investigator: Karin McLelland, MD            
Tarheel Clinical Research Recruiting
Holly Springs, North Carolina, United States, 27540
Contact: Seltzer Earl, Dr.     919-781-2514     eseltzer@wakeresearch.com    
Principal Investigator: Olga Nilova, MD            
United States, Ohio
Ohio Pediatric Research Assn. Recruiting
Huber Heights, Ohio, United States, 45424
Contact: Julie Shepard, MD, MPH     937-424-9294     jshepard@ohiopediatricresearch.com    
Principal Investigator: Julie Shepard, MD, MPH            
Institute of Clinical Research Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Jennifer Deacon, Dr.     440-605-0090     ICR@lightstream.net    
Principal Investigator: James Guerrieri, MD            
United States, South Carolina
Spartanburg Medical Research Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Tessa Wilson, Dr.     864-583-1556     twilson@medresearch.com    
Principal Investigator: Sheri Byrd, MD, CPI            
United States, Utah
Tanner Clinic Recruiting
Layton, Utah, United States, 84041
Contact: Marijke Reiva, Dr.     801-773-4840 ext 3282     mreiva@tannerclinic.com    
Principal Investigator: Brent Eberhard, MD            
Jean Brown Research Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Carol Minoughan, Dr.     801-261-2000     cminoughan@jeanbrownresearch.com    
Principal Investigator: Derek Muse, MD            
Hobble Creek Medical Clinic Recruiting
Springville, Utah, United States, 84663
Contact: George Michalek, MD     810-404-6420     gmichalek@researchutah.com    
Principal Investigator: George Michalek, MD            
United States, Virginia
Clinical Research Partners, LLC Recruiting
Richmond, Virginia, United States, 23223
Contact: Jeanette Weller, Dr.     804-288-7425     jw@crpllc.info    
Principal Investigator: Bennett Richard, MD            
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: January 16, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013