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Assessment of Growth of Infants Fed a New Formula

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ClinicalTrials.gov Identifier: NCT00937014
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : June 26, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
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 or disease Intervention/treatment Phase
Infant Nutrition Other: standard infant formula Other: Test formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin
Study Start Date : February 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Mean weight gain [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. anthropometry, tolerance, morbidity, blood tests [ Time Frame: 9 months ]


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Ages Eligible for Study:   up to 17 Days   (Child)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00937014     History of Changes
Other Study ID Numbers: 07.35.INF
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Nestlé:
infant formula
growth
weight

Additional relevant MeSH terms:
Lactoferrin
Anti-Infective Agents