CompletedPhase 4

Role of Pepsin Assay in Wheezy Infants

52 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range6 Months – 2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants in Each Level of Wheeze Control

Timeframe: 3 months

Trial details

NCT IDNCT02685436

SponsorMansoura University Children Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

Results submitted2016-03-03

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials