Role of Pepsin Assay in Wheezy Infants

Mansoura University Children Hospital

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Omeprazole and domperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT02685436

1722011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 6 months to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

omeprazole and domperidone

Other group

Description:

wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).

Treatment:

Drug: Omeprazole and domperidone