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Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

This study is currently recruiting participants.
Verified May 2013 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01210391
First received: September 27, 2010
Last updated: May 15, 2013
Last verified: May 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 extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.


Condition Intervention
Growth
 Other: Extensively hydrolyzed whey infant formula
Other: Extensively hydrolyzed casein infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

Resource links provided by NLM:

Drug Information available for: Casein
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.


Estimated Enrollment: 112
Study Start Date: November 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New hydrolyzed infant formula
New, extensively hydrolyzed infant formula
 Other: Extensively hydrolyzed whey infant formula
New hydrolyzed infant formula.
Other Name: Baby Formula
Active Comparator: Commercially available infant formula
Commercially available, extensively hydrolyzed infant formula.
 Other: Extensively hydrolyzed casein infant formula
Commercially available infant formula.
Other Name: Baby Formula

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy newborn singleton infant
  • Full-term (>= 37 weeks gestation)
  • Birth weight between >= 2500 and < =4500 g
  • 14 ± 3 days of age on enrollment
  • Infant's mother has elected not to breastfeed
  • baby has been exclusively formula fed a minimum of 3 days prior to enrollment
  • Study explained and written information provided with Parent/Caregiver
  • Informed consent signed (parent/legal representative)

Exclusion Criteria:

  • Congenital illness or malformation affecting infant feeding and/or 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 enrollment
  • Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment
  • 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 has received probiotics in the seven days prior to enrollment
  • Infant currently participating in another 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: NCT01210391

Contacts
Contact: Terri Voss +1 (973) 593-7779 terri.voss@rd.nestle.com

Locations
United States, Colorado
Colorado Springs Health Partners Recruiting
Colorado Springs, Colorado, United States
Contact: Alan Garscadden, MD            
Principal Investigator: Alan Garscadden, MD            
United States, Indiana
Pedia Research Recruiting
Newburgh, Indiana, United States, 42301
Contact: Karen Robertson     812-457-4296        
Principal Investigator: Richard Litov, PhD            
United States, Kentucky
Pedia Research Recruiting
Owensboro, Kentucky, United States, 42301
Contact: Sabrina Grant     270-685-4589        
Principal Investigator: Richard Litov, PhD            
United States, Louisiana
ARK-LA-Tex Pediatric Research Recruiting
Bossier City, Louisiana, United States
Contact: Megan Gardner, MD            
Principal Investigator: Megan Gardner, MD            
The Clinical Trials Center Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Stephanie Sonnier     504-894-5377        
Principal Investigator: Ricardo Sorensen, MD            
United States, Nevada
Clinical Research of Nevada Recruiting
Las Vegas, Nevada, United States
Contact: Timothy Sauter, MD            
Principal Investigator: Timothy Sauter, MD            
United States, Ohio
Institute of Clinical Research Recruiting
Mayfield Heights, Ohio, United States
Contact: James Guerrieri, MD            
Principal Investigator: James Guerrieri, MD            
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Catherine Wolf     405-271-8001 ext 42794        
Principal Investigator: David Fields, PhD            
United States, Oregon
Cyn3rgy Research Recruiting
Gresham, Oregon, United States
Contact: Frank Calcagno, MD            
Principal Investigator: Frank Calcagno, MD            
United States, Pennsylvania
Square-1 Clinical Research Recruiting
Erie, Pennsylvania, United States
Contact: Anne Zomcik, MD            
Principal Investigator: Anne Zomcik, MD            
United States, Tennessee
Alpha Clinical Research Recruiting
Clarksville, Tennessee, United States
Contact: Laurie Harris-Ford, MD            
Principal Investigator: Laure Harris-Ford, MD            
Jackson Clinic Recruiting
Jackson, Tennessee, United States, 38305
Contact: William Stepp, MD            
Principal Investigator: William Stepp, MD            
United States, Texas
Scott & White Wells Branch Clinic Recruiting
Austin, Texas, United States, 78728
Contact: Jill Meredith     512-218-6375        
Principal Investigator: Jennifer Helmcamp, MD            
Scott & White Killeen Clinic Recruiting
Killeen, Texas, United States, 76543
Contact: Lydia Clipper     254-724-8193        
Principal Investigator: Stuart Coles, MD            
DCOL Center for Research Recruiting
Longview, Texas, United States
Contact: Cynthia Somers-Ariette, MD            
Principal Investigator: Cynthia Somers-Arietti, MD            
Southwest Children's Research Associates Recruiting
San Antonio, Texas, United States, 78229
Contact: Brandi Young     210-614-7814        
Principal Investigator: Tina Boylston, MD            
Scott & White Temple Recruiting
Temple, Texas, United States, 76508
Contact: Lindsay Newman     254-724-1099        
Principal Investigator: Sharyl Santema, MD            
United States, Utah
Tanner Clinic Recruiting
Layton, Utah, United States
Contact: Brent Eberhard, MD            
Principal Investigator: Brent Eberhard, MD            
United States, Virginia
Clinical Research Partners Recruiting
Richmond, Virginia, United States
Contact: Richard Bennett, MD            
Principal Investigator: Richard Bennett, MD            
United States, Washington
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States
Contact: James Jantzen, MD            
Principal Investigator: James Jantzen, MD            
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Ricardo Sorensen, MD Louisiana State University Health Sciences Center in New Orleans
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01210391     History of Changes
Other Study ID Numbers: 09.43.PED
Study First Received: September 27, 2010
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013