Status:
COMPLETED
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Gastroesophageal Reflux
Esophageal Atresia
Eligibility:
All Genders
6-3 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.
Detailed Description
Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact ext...
Eligibility Criteria
Inclusion
- Infants were eligible for the study if they were:
- 6-12 weeks postnatal age
- weighed more than 3 kg
- were after surgical repair for EA or CDH
- showed clinical GERD
- were to undergo the 48 hour pH measurements.
- Infants were excluded if they were:
- allergic to omeprazole
- participated in other interventional trials
- used medications known to interact with omeprazole.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00226044
Start Date
September 1 2005
End Date
September 1 2017
Last Update
October 7 2019
Active Locations (1)
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1
Erasmus Medical center
Rotterdam, Netherlands, 3015 GD