Skip to main content
OpenTrials
Completed

NCT Number: NCT02685436

Role of Pepsin Assay in Wheezy Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole and domperidone

Drug

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)

Other names: omipak , motilium

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2016
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.