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

Primary Purpose

Necrotizing Enterocolitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Docosahexaenoic Acid
placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis

Eligibility Criteria

1 Day - 3 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Docosahexaenoic Acid Group

    Control Group

    Arm Description

    participants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days

    participants will recieve placebo

    Outcomes

    Primary Outcome Measures

    Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.
    Monitoring the change in the serum levels of Interleukin-1 beta

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2018
    Last Updated
    October 6, 2018
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03700957
    Brief Title
    The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
    Official Title
    A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotizing Enterocolitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Docosahexaenoic Acid Group
    Arm Type
    Experimental
    Arm Description
    participants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    participants will recieve placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Docosahexaenoic Acid
    Intervention Description
    100 milligrams of Docosahexaenoic Acid
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.
    Description
    Monitoring the change in the serum levels of Interleukin-1 beta
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    3 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina Abou El Fadl, Msc.
    Phone
    201005442855
    Email
    dkhaled69@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmine Farid, MD
    Phone
    201001449558
    Email
    Yasmin_Aly_Farid@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dina Abou El Fadl, Msc.
    Organizational Affiliation
    Future University in Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28096129
    Citation
    Shulhan J, Dicken B, Hartling L, Larsen BM. Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products. Adv Nutr. 2017 Jan 17;8(1):80-91. doi: 10.3945/an.116.013193. Print 2017 Jan.
    Results Reference
    background
    PubMed Identifier
    26846324
    Citation
    Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. Daily Enteral DHA Supplementation Alleviates Deficiency in Premature Infants. Lipids. 2016 Apr;51(4):423-33. doi: 10.1007/s11745-016-4130-4. Epub 2016 Feb 4.
    Results Reference
    background
    PubMed Identifier
    34819793
    Citation
    Abou El Fadl DK, Ahmed MA, Aly YA, Darweesh EAG, Sabri NA. Impact of Docosahexaenoic acid supplementation on proinflammatory cytokines release and the development of Necrotizing enterocolitis in preterm Neonates: A randomized controlled study. Saudi Pharm J. 2021 Nov;29(11):1314-1322. doi: 10.1016/j.jsps.2021.09.012. Epub 2021 Sep 25.
    Results Reference
    derived

    Learn more about this trial

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

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