Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2010-02-28
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Standard infant formula
standard infant formula
Standard infant formula given during the first 9 months of life, as per standard requirement
Test formula
Test formula
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
Interventions
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standard infant formula
Standard infant formula given during the first 9 months of life, as per standard requirement
Test formula
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Days
17 Days
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Feigelman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland School of Medicine, Department of Pediatrics
Locations
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Pedia Research, LLC
Newburgh, Indiana, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Countries
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Other Identifiers
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07.35.INF
Identifier Type: -
Identifier Source: org_study_id
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