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NCT02685436 Clinical Trial

Role of Pepsin Assay in Wheezy Infants

Gastroesophageal Reflux Disease Clinical Trial

Official title:
Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02685436
Other study ID # 1722011
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2013
Est. completion date May 2015

Study information
Verified date September 2019
Source Mansoura University Children Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 6 Months to 2 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Omeprazole and domperidone
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)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University Children Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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