Evaluation of a Novel Human Milk Fortifier in Preterm Infants
1 other identifier
interventional
147
1 country
15
Brief Summary
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 20, 2013
February 1, 2013
1.3 years
June 8, 2011
February 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Weight gain
29 days
Secondary Outcomes (2)
Anthropometric variables
29 days
GI tolerance
29 days
Study Arms (2)
Experimental Human Milk Fortifier
EXPERIMENTALExperimental human milk fortifier to be added to human milk
Control Human Milk Fortifier
ACTIVE COMPARATORControl human milk fortifier to be added to human milk
Interventions
Human milk fortifier to be added to human milk feedings
Control human milk fortifier to be added to human milk
Eligibility Criteria
You may qualify if:
- g birth weight
- 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
You may not qualify if:
- Feeding preterm infant formula or non-study human milk fortifier
- Expected at facility less than 15 days
- Congenital anomalies/disease affecting growth and development
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (15)
University of Alabama
Birmingham, Alabama, 35249-7335, United States
UCSD Medical Center
San Diego, California, 92103-8774, United States
University South Florida
Tampa, Florida, 33606, United States
Memorial Hospital of Southbend
Southbend, Indiana, 46601, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
King's County Hospital Center
Brooklyn, New York, 11203, United States
Cohen Children's Medical Center of New York at North Shore
Manhasset, New York, 11030, United States
Cohen Children's Medical Center of NY at North Shore
New Hyde Park, New York, 11040, United States
Childrens Hospital Westchester Medical Center
Valhalla, New York, 10595, United States
University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
OHSU
Portland, Oregon, 97239, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (1)
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.
PMID: 26488118DERIVED
Study Officials
- STUDY CHAIR
Bridget Barrett-Reis, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 14, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 20, 2013
Record last verified: 2013-02