Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2013-09-30
2016-04-30
Brief Summary
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Detailed Description
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Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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"high" dose LCPUFA
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement
"low" dose LCPUFA
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement
placebo
the "placebo" is a drop that will be administered to ELBW infants.
placebo
Interventions
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LCPUFA supplement
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* b) Birth weight less than 1000 grams
* c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures
Exclusion Criteria
* b) infants with known congenital gastrointestinal anomaly
* c) infants who are deemed to be inappropriate for enrollment per attending neonatologist
72 Hours
ALL
Yes
Sponsors
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Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Northwestern University Feinberg School of Medicine
OTHER
Mead Johnson Nutrition
INDUSTRY
Endeavor Health
OTHER
Responsible Party
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Brandy Frost
Attending Neonatologist, Clinician Educator
Principal Investigators
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Michael S Caplan, MD
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Locations
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Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Prentice Women's Hospital
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Countries
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References
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Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3.
Other Identifiers
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EH13-334
Identifier Type: -
Identifier Source: org_study_id
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