Assessment of Growth of Infants Fed a New Formula

June 24, 2013 updated by: Nestlé

Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Pedia Research, LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine

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 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy newborn infant
  • Full-term (>37 weeks gestation)
  • Birth weight between > 2500 and < 4500 g
  • Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
  • Tolerating a cows milk based formula for at least 3 days
  • Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
  • Informed consent signed (Parent/Legal representative)
  • Parent/Caregiver has a working freezer
  • Lives within 45 minutes of a study site

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 enrollment
  • Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
  • Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
  • 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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard infant formula
Other: standard infant formula
Standard infant formula given during the first 9 months of life, as per standard requirement
Experimental: Test formula
Other: Test formula
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean weight gain
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
anthropometry, tolerance, morbidity, blood tests
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

Nestlé

Investigators

  • Principal Investigator: Susan Feigelman, MD, University of Maryland School of Medicine, Department of Pediatrics

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

February 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07.35.INF

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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