Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

June 25, 2014 updated by: Nestlé

Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New hydrolyzed infant formula
New, extensively hydrolyzed infant formula
Other: Extensively hydrolyzed whey infant formula
New hydrolyzed infant formula.
Other Names:
  • 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 Names:
  • Baby Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Gain
Time Frame: 4 Months
Mean weight gain (g/day) from enrollment to 4 months of age.
4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Ricardo Sorensen, MD, Louisiana State University Health Sciences Center in New Orleans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.43.PED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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