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Role of Pepsin Assay in Wheezy Infants

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Omeprazole and domperidone
Sponsored by
Mansoura University Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease

Eligibility Criteria

6 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants with physician documented 3 attacks of wheezing episodes over the last 6 months or persistent wheeze over the last one month

Exclusion Criteria:

  • Wheezy infants with atopy (allergic rhino-conjunctivitis or eczema), prematurity (less than 34 weeks), abnormal neurological examination, congenital heart diseases, airspace opacity on chest radiography, tracheal-bronchial malformations, immune deficiency and anatomical esophageal or gastric malformations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    omeprazole and domperidone

    Arm Description

    wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).

    Outcomes

    Primary Outcome Measures

    Number of Participants in Each Level of Wheeze Control
    Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2016
    Last Updated
    September 13, 2019
    Sponsor
    Mansoura University Children Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02685436
    Brief Title
    Role of Pepsin Assay in Wheezy Infants
    Official Title
    Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University Children Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and exacerbations recurrence.
    Detailed Description
    Wheezy infants were tested for gastro-esophageal reflux disease using combined MII-pH, EGD, LLMI and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole for 12 weeks then re-evaluated for symptoms control and wheeze exacerbations recurrence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    omeprazole and domperidone
    Arm Type
    Other
    Arm Description
    wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
    Intervention Type
    Drug
    Intervention Name(s)
    Omeprazole and domperidone
    Other Intervention Name(s)
    omipak , motilium
    Intervention Description
    wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s)
    Primary Outcome Measure Information:
    Title
    Number of Participants in Each Level of Wheeze Control
    Description
    Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants with physician documented 3 attacks of wheezing episodes over the last 6 months or persistent wheeze over the last one month Exclusion Criteria: Wheezy infants with atopy (allergic rhino-conjunctivitis or eczema), prematurity (less than 34 weeks), abnormal neurological examination, congenital heart diseases, airspace opacity on chest radiography, tracheal-bronchial malformations, immune deficiency and anatomical esophageal or gastric malformations
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tarek El-Desoky
    Organizational Affiliation
    Faculty if medicine, Mansoura University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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