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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700957
Recruitment Status : Unknown
Verified October 2018 by Dina Khaled Mohamed Abou El Fadl, Future University in Egypt.
Recruitment status was:  Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Khaled Mohamed Abou El Fadl, Future University in Egypt

Study Description
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Brief Summary:
The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Dietary Supplement: Docosahexaenoic Acid Other: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700957


Contacts
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Contact: Dina Abou El Fadl, Msc. 201005442855 dkhaled69@gmail.com
Contact: Yasmine Farid, MD 201001449558 Yasmin_Aly_Farid@hotmail.com

Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Dina Abou El Fadl, Msc. Future University in Egypt
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dina Khaled Mohamed Abou El Fadl, Assistant Lecturer, Future University in Egypt
ClinicalTrials.gov Identifier: NCT03700957    
Other Study ID Numbers: 73
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases