Role of Pepsin Assay in Wheezy Infants
Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants
1 other identifier
interventional
52
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2013
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 3, 2016
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedResults Posted
Study results publicly available
October 7, 2019
CompletedOctober 7, 2019
September 1, 2019
2.2 years
February 3, 2016
March 3, 2016
September 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 months
Study Arms (1)
omeprazole and domperidone
OTHERwheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
Interventions
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)
Eligibility Criteria
You may qualify if:
- Infants with physician documented 3 attacks of wheezing episodes over the last 6 months or persistent wheeze over the last one month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Non randomization
Results Point of Contact
- Title
- Dr.Ahmed Zaki
- Organization
- Manicure university children hospital
Study Officials
- STUDY DIRECTOR
Tarek El-Desoky
Faculty if medicine, Mansoura University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 3, 2016
First Posted
February 18, 2016
Study Start
March 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 7, 2019
Results First Posted
October 7, 2019
Record last verified: 2019-09