The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates

October 6, 2018 updated by: Dina Khaled Mohamed Abou El Fadl, Ain Shams University

A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates

The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in preterm neonates will be evalutaed through measuring its immune-modulatory effect on proinflammatory cytokines.

Study Type

Interventional

Enrollment (Anticipated)

60

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.

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

1 day to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm neonates having a gestational age equal or less than 34 weeks at birth.
  • Weight (less than or equal 1.500 KG)
  • Clinically stable to begin enteral feeding

Exclusion Criteria:

  • Persistent bleeding at any level.
  • Receiving medication to avoid coagulation.
  • Persistent vomiting.
  • Gastrointestinal malformations.
  • Mother taking Omega-3 supplements and planning to breastfeed.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docosahexaenoic Acid Group
participants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days
Dietary supplement: Docosahexaenoic Acid
100 milligrams of Docosahexaenoic Acid
Placebo Comparator: Control Group
participants will recieve placebo
Other: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.
Time Frame: 10 days
Monitoring the change in the serum levels of Interleukin-1 beta
10 days

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Dina Abou El Fadl, Msc., Future university in egypt

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 (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 29, 2018

First Submitted That Met QC Criteria

October 6, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 6, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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