Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01210391
First received: September 27, 2010
Last updated: June 25, 2014
Last verified: June 2014
  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:


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.


Enrollment: 282
Study Start Date: November 2010
Study Completion Date: July 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: June 25, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014