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Assessment of Growth of Infants Fed a New Formula

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00937014
First received: July 9, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Infant Nutrition
Other: standard infant formula
Other: Test formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Mean weight gain [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • anthropometry, tolerance, morbidity, blood tests [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 17 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00937014

Locations
United States, Indiana
Pedia Research, LLC
Newburgh, Indiana, United States, 47630
United States, Kentucky
Pedia Research, LLC
Owensboro, Kentucky, United States, 42301
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Susan Feigelman, MD University of Maryland School of Medicine, Department of Pediatrics
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00937014     History of Changes
Other Study ID Numbers: 07.35.INF
Study First Received: July 9, 2009
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
infant formula
growth
weight

ClinicalTrials.gov processed this record on November 25, 2014