Role of Pepsin Assay in Wheezy Infants

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Omeprazole and domperidone

• Registration Number: NCT02685436
• Lead Sponsor: Mansoura University Children Hospital

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-13
• Study First Posted: 2016-02-18
• Results First Submitted: 2016-03-03
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Results First Posted: 2019-10-07
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
omeprazole and domperidone	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants in Each Level of Wheeze Control	3 months	Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing