Phase 4
N=52
Role of Pepsin Assay in Wheezy Infants
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT02685436 ↗Enrolled (actual)
52
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants in Each Level of Wheeze Control — 18; 11; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omeprazole and domperidone (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Mansoura University Children Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Each Level of Wheeze Control |
18; 11; 9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02685436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.