PUFA Supplementation in Premature Infants

August 13, 2021 updated by: Brandy Frost, NorthShore University HealthSystem

Early DHA Supplementation in Extremely Low Birth Weight Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60611
        • Prentice Women's Hospital
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: "high" dose LCPUFA
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Dietary supplement: LCPUFA supplement
Other Names:
  • PUFA supplement
EXPERIMENTAL: "low" dose LCPUFA
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Dietary supplement: LCPUFA supplement
Other Names:
  • PUFA supplement
PLACEBO_COMPARATOR: placebo
the "placebo" is a drop that will be administered to ELBW infants.
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
Time Frame: 2 weeks of life
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
2 weeks of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LCPUFA Levels
Time Frame: 8 weeks of life
LCPUFA levels will be measured at 8 weeks of life.
8 weeks of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago
Northwestern University Feinberg School of Medicine
Mead Johnson Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (ESTIMATE)

October 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH13-334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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