Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
NCT ID: NCT01987154
Last Updated: 2016-05-17
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
61 participants
INTERVENTIONAL
2014-02-28
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TRIPLE
Study Groups
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Marketed cow milk-based premature infant formula
Marketed cow milk-based premature infant formula
Marketed extensively hydrolyzed casein infant formula
Marketed extensively hydrolyzed casein infant formula
Interventions
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Marketed cow milk-based premature infant formula
Marketed extensively hydrolyzed casein infant formula
Eligibility Criteria
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Inclusion Criteria
* Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
* Birth weight is greater than or equal to 700g to 1750g
* Appropriate birth weight for gestational age
* Singleton or twin birth
* Signed Informed consent
Exclusion Criteria
* 5 minute APGAR score is less than or equal to 4
* Major surgery that required general anesthesia prior to randomization
* Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
* Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
* Infant is currently participating in another clinical study
ALL
No
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Mariella Baldassarre, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universita degli Studi di Bari
Locations
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Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari
Bari, Apulia, Italy
Countries
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Other Identifiers
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6020
Identifier Type: -
Identifier Source: org_study_id
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