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The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants (NEC)

Primary Purpose

Necrotizing Enterocolitis, Sepsis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus Reuteri DSM 17938
Placebo
Sponsored by
Children's Hospital and Institute of Child Health, Multan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring Necrotizing Enterocolitis,, lactobacillus reuteri ds 17938

Eligibility Criteria

28 Weeks - 34 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically stable

Exclusion Criteria:

  • Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory illness Parental refusal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    drug group

    control group

    Arm Description

    The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds

    this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed

    Outcomes

    Primary Outcome Measures

    narcotizing enterocolitis
    number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs

    Secondary Outcome Measures

    sepsis
    number of participants who developed sepsis proven by blood cultures before of after intervention

    Full Information

    First Posted
    August 5, 2020
    Last Updated
    September 7, 2020
    Sponsor
    Children's Hospital and Institute of Child Health, Multan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04541771
    Brief Title
    The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants
    Acronym
    NEC
    Official Title
    The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Hospital and Institute of Child Health, Multan

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan. Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotizing Enterocolitis, Sepsis
    Keywords
    Necrotizing Enterocolitis,, lactobacillus reuteri ds 17938

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    participants will be divided in two groups. one is control group and the other Interventional group. control group will receive the drug under study and control will be given placebo for the period of until they complete 35 weeks of gestation or discharged.
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    drug group
    Arm Type
    Experimental
    Arm Description
    The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed
    Intervention Type
    Drug
    Intervention Name(s)
    Lactobacillus Reuteri DSM 17938
    Intervention Description
    The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds
    Primary Outcome Measure Information:
    Title
    narcotizing enterocolitis
    Description
    number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs
    Time Frame
    up to 35 weeks of gestation
    Secondary Outcome Measure Information:
    Title
    sepsis
    Description
    number of participants who developed sepsis proven by blood cultures before of after intervention
    Time Frame
    At time of addmission and 15 days after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    34 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically stable Exclusion Criteria: Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory illness Parental refusal
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    STabasum
    Phone
    03417236837
    Email
    dr.sumeratabasum@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    summera tabasum
    Organizational Affiliation
    CH&ICH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants

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