Evaluation of a Novel Human Milk Fortifier in Preterm Infants
NCT ID: NCT01373073
Last Updated: 2013-02-20
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
PHASE3
147 participants
INTERVENTIONAL
2011-08-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Human Milk Fortifier
Experimental human milk fortifier to be added to human milk
Experimental human milk fortifier
Human milk fortifier to be added to human milk feedings
Control Human Milk Fortifier
Control human milk fortifier to be added to human milk
Control human milk fortifier
Control human milk fortifier to be added to human milk
Interventions
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Experimental human milk fortifier
Human milk fortifier to be added to human milk feedings
Control human milk fortifier
Control human milk fortifier to be added to human milk
Eligibility Criteria
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Inclusion Criteria
* 33 weeks or less gestational age
* Appropriate for gestational age
* Initiate enteral feeds of human milk by 21 days of life
* Mother provided exclusive human milk feeds
* Parents allow both human milk and study human milk fortifier
* Singleton or twin birth
Exclusion Criteria
* Expected at facility less than 15 days
* Congenital anomalies/disease affecting growth and development
* 5 minute APGAR of 4 or less
* Steroid use
* ECMO
* Grade III or IV PVH/IVH
* Mechanical ventilator dependency
* Maternal incapacity
* History of major surgery
* Asphyxia
* Confirmed NEC or sepsis
* Use of probiotics
21 Days
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Bridget Barrett-Reis, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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University of Alabama
Birmingham, Alabama, United States
UCSD Medical Center
San Diego, California, United States
University South Florida
Tampa, Florida, United States
Memorial Hospital of Southbend
Southbend, Indiana, United States
Wesley Medical Center
Wichita, Kansas, United States
King's County Hospital Center
Brooklyn, New York, United States
Cohen Children's Medical Center of New York at North Shore
Manhasset, New York, United States
Cohen Children's Medical Center of NY at North Shore
New Hyde Park, New York, United States
Childrens Hospital Westchester Medical Center
Valhalla, New York, United States
University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
OHSU
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010.
Other Identifiers
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AK37
Identifier Type: -
Identifier Source: org_study_id
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