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Growth of Infants Fed an Extensively Hydrolyzed 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.
ClinicalTrials.gov Identifier: NCT01210391
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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 extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.

Condition or disease Intervention/treatment
Growth Other: Extensively hydrolyzed whey infant formula Other: Extensively hydrolyzed casein infant formula

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.
Study Start Date : November 2010
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01210391


Locations
United States, Colorado
Colorado Springs Health Partners
Colorado Springs, Colorado, United States
United States, Indiana
Pedia Research
Newburgh, Indiana, United States, 42301
United States, Kentucky
Pedia Research
Owensboro, Kentucky, United States, 42301
United States, Louisiana
ARK-LA-Tex Pediatric Research
Bossier City, Louisiana, United States
The Clinical Trials Center
New Orleans, Louisiana, United States, 70118
United States, Nevada
Clinical Research of Nevada
Las Vegas, Nevada, United States
United States, Ohio
Institute of Clinical Research
Mayfield Heights, Ohio, United States
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States
United States, Pennsylvania
Square-1 Clinical Research
Erie, Pennsylvania, United States
United States, Tennessee
Alpha Clinical Research
Clarksville, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States, 38305
United States, Texas
Scott & White Wells Branch Clinic
Austin, Texas, United States, 78728
Scott & White Killeen Clinic
Killeen, Texas, United States, 76543
DCOL Center for Research
Longview, Texas, United States
Southwest Children's Research Associates
San Antonio, Texas, United States, 78229
Scott & White Temple
Temple, Texas, United States, 76508
United States, Utah
Tanner Clinic
Layton, Utah, United States
United States, Virginia
Clinical Research Partners
Richmond, Virginia, United States
United States, Washington
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Ricardo Sorensen, MD Louisiana State University Health Sciences Center in New Orleans
More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01210391     History of Changes
Other Study ID Numbers: 09.43.PED
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014