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PUFA Supplementation in Premature Infants

Not Applicable
Completed
Conditions
Premature, Extremely Low Birth Weight Infants
Polyunsaturated Fatty Acid Levels
Registration Number
NCT01955044
Lead Sponsor
NorthShore University HealthSystem
Brief Summary

The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.

Detailed Description

This will be a multi-center, randomized, placebo controlled, double blind trial.

Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.

ELBW infants will be enrolled into this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • a) Premature infant born at gestational age less than 34 weeks
  • 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
  • a) infants with known metabolic disorder
  • b) infants with known congenital gastrointestinal anomaly
  • c) infants who are deemed to be inappropriate for enrollment per attending neonatologist

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 weeks of life

LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Secondary Outcome Measures
NameTimeMethod
LCPUFA Levels8 weeks of life

LCPUFA levels will be measured at 8 weeks of life.

Trial Locations

Locations (3)

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

Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States

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