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PUFA Supplementation in Premature Infants

NCT01955044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-05

Study results available
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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.

Conditions

  • Premature, Extremely Low Birth Weight Infants
  • Polyunsaturated Fatty Acid Levels

Interventions

DIETARY_SUPPLEMENT

LCPUFA supplement

DIETARY_SUPPLEMENT

placebo

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Northwestern University Feinberg School of Medicine

    collaborator OTHER

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Michael S Caplan, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01955044 on ClinicalTrials.gov