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
164 participants
INTERVENTIONAL
2014-12-31
2017-02-28
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
OTHER
NONE
Study Groups
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Study Human Milk Fortifier A
Acidified processing method.
Human Milk Fortifier A
Acidified concentrated liquid human milk fortifier
Study Human Milk Fortifier B
Non-acidified processing method.
Human Milk Fortifier B
Non-acidified concentrated liquid human milk fortifier
Interventions
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Human Milk Fortifier A
Acidified concentrated liquid human milk fortifier
Human Milk Fortifier B
Non-acidified concentrated liquid human milk fortifier
Eligibility Criteria
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Inclusion Criteria
* ≤ 32 weeks and 0 days GA at birth.
* Appropriate for GA (AGA).
* Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).
* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.
* Parent(s) agrees to allow infant to receive both human milk and HMF.
* Singleton or twin births only.
Exclusion Criteria
* Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
* Serious congenital abnormalities or underlying disease that may affect growth and development.
* 5 minute APGAR ≤ 4.
* Steroids used at the time of randomization.
* Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
* Mechanical ventilator dependence.
* Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).
* Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
* Participation in another study that has not been approved as a concomitant study by AN.
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, RD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Yale University
New Haven, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
South Miami Hospital
Miami, Florida, United States
All Children's Hospital / Johns Hopkins
St. Petersburg, Florida, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Cohen Children's Medical Center of NY at North Shore
Manhasset, New York, United States
Cohen Children's Medical Center of NY
New Hyde Park, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Doctors Hospital at Renaissance/Women's Hospital at Renaissance
Edinburg, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Health and Education Institute
Fort Worth, Texas, United States
North Central Baptist Hospital
San Antonio, Texas, United States
Wheaton Franciscan Heathcare Inc.- St. Joseph
Milwaukee, Wisconsin, United States
Countries
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References
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Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y.
Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5.
Other Identifiers
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AL16
Identifier Type: -
Identifier Source: org_study_id
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