Early DHA Supplementation in Very Low Birth Weight Infants

May 6, 2019 updated by: Mead Johnson Nutrition
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • North Shore University Health System

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Very low birth weight infants weighing less than 1500 grams
  • Consent signed within 72 hours of life

Exclusion Criteria:

  • Infants with know metabolic disorder
  • Infants with known congenital GI anomaly
  • 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: Low dose PUFA
Other: Low dose PUFA
Low dose PUFA
Experimental: High dose PUFA
Other: High dose PUFA
High dose PUFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Red Blood Cell polyunsaturated fatty acids (PUFA) levels
Time Frame: 2 weeks of age
2 weeks of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Red Blood Cell PUFA levels
Time Frame: 8 weeks of age
8 weeks of age
Feeding tolerance
Time Frame: 8 weeks
Full enteral feed of 120 kcal/kg/day
8 weeks
Incidence of necrotizing enterocolitis
Time Frame: 8 weeks
8 weeks
Incidence of bronchopulmonary dysplasia
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Collaborators

North Shore Research Institue

Investigators

  • Study Director: Timothy Cooper, M.D, 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 (Actual)

July 1, 2017

Primary Completion (Actual)

July 9, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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