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Clinical Trials/NCT02685436
NCT02685436CompletedPhase 4

Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants

Mansoura University Children Hospital0 sites52 target enrollmentStarted: March 2013Last updated:
Conditions
Interventions
Drugs

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

Other

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

Sponsor
Mansoura University Children Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Zaki

Lecturer

Mansoura University Children Hospital

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