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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NOT_YET_RECRUITING
NA
321 participants
INTERVENTIONAL
2024-09-30
2028-01-31
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
OTHER
QUADRUPLE
Study Groups
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Control Product
Control Human Milk Fortifier added to human milk feedings
Control Product
Fed from Study Day 1
Product 1
Study Human Milk Fortifier added to human milk feedings
Experimental Product 1
Fed from Study Day 1
Product 2
Study Human Milk Fortifier added to human milk feedings
Experimental Product 2
Fed from Study Day 1
Interventions
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Control Product
Fed from Study Day 1
Experimental Product 1
Fed from Study Day 1
Experimental Product 2
Fed from Study Day 1
Eligibility Criteria
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Inclusion Criteria
* ≤ 32 weeks and 0 days GA at birth.
* Participant has been classified as appropriate for GA (AGA).
* Enteral feeding of human milk must be 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 fortified with study fortifier and use of mother's own milk (when available) is prioritized.
* Parent(s) agrees to allow infant to receive both human milk and study HMF.
* Singleton or twin births only.
* Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion Criteria
* Expected to be transferred to another facility within 30 days of randomization.
* Serious congenital abnormalities or underlying disease that may affect growth and development.
* 5-minute APGAR ≤ 4.
* Receiving systemic steroids at time of randomization.
* Receiving probiotics at time of randomization.
* Grade Ill or IV PVH/IVH.
* Dependent on invasive ventilation at time of randomization.
* Maternal incapacity.
* Mother or infant is currently receiving treatment consistent with HIV therapy.
* Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.
* Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.
* 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.
* Confirmed NEC (Bell's Stage II or III).
* Confirmed current sepsis.
* 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.
* Participant has an allergy or intolerance to any ingredient in study fortifier.
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Reverri, PhD, MS, RD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Banner - University Medical Center
Phoenix, Arizona, United States
UAMS Medical Center
Little Rock, Arkansas, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
South Miami Hospital
Miami, Florida, United States
AdventHealth
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Tufts Medical Center
Boston, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of New Mexico Children's Hospital
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Woman's Hospital of Texas
Houston, Texas, United States
St. Luke's Baptist Hospital
San Antonio, Texas, United States
WVU Medicine Children's Hospital
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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AL46
Identifier Type: -
Identifier Source: org_study_id
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