Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Collaborator: Erasmus Medical Center
• Treatments: Omeprazole

Criteria

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.