Role of Pepsin Assay in Wheezy Infants

M

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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