Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Primary Endpoint
- Number of Participants in Each Level of Wheeze Control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
omeprazole and domperidone
wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
Intervention: Omeprazole and domperidone (Drug)
Outcomes
Primary Outcomes
Number of Participants in Each Level of Wheeze Control
Time Frame: 3 months
Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Zaki
Lecturer
Mansoura University Children Hospital