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
206 participants
INTERVENTIONAL
2005-05-31
2008-08-31
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
QUADRUPLE
Study Groups
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Infant Formula
Preterm infant formulas containing lipid soluble compounds
Preterm infant formula with added soluble lipids
Preterm infant formula to be fed per healthcare provider instructions
Preterm formulas
Standard preterm infant formula and discharge formulas
Preterm infant formulas and discharge formulas
Preterm infant formulas to be consumed per health care provider orders
Interventions
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Preterm infant formulas and discharge formulas
Preterm infant formulas to be consumed per health care provider orders
Preterm infant formula with added soluble lipids
Preterm infant formula to be fed per healthcare provider instructions
Eligibility Criteria
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Inclusion Criteria
* Less than 33 wks gestational age
* Enteral feeding initiated by 21 days of life
* Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
* Singleton or twin births only
* Infant is 21 days of age or less at time of randomization
Exclusion Criteria
* Grade III or IV intraventricular hemorrhage (IVH)
* Maternal incapacity
* History of major surgery
* Extracorporeal membrane oxygenation (ECMO)
* Asphyxia
* Confirmed NEC or positive blood cultures at the time of randomization
21 Days
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
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
West Coast Neonatalogy, All Children's Hospital
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Maria Fareri Children's Hospital at Winchester Medical Center
Vahalla, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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AK15
Identifier Type: -
Identifier Source: org_study_id
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