Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years.

Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years. - Treatment with domperidone and omeprazole in GERD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37309

Enrollment

Registered

2007-06-28

Start date

2008-01-18

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD (=gastro-esophageal reflux disease) reflux

Interventions

One group uses 1 mg/kg domperidone suspension (4dd), one group uses 2-3 mg/kg omeprazole mups (2dd) and one group with both domperidone and omeprazole.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Gastro-oesophageal reflux disease diagnosed by 24-h oesophageal pH monitoring

Exclusion criteria

Exclusion criteria: 1. Gastro-oesophageal reflux disease for which treatment has started. 2. Infants with gastro-oesophageal reflux disease presenting with an apparant life threatening event (ALTE)

Design outcomes

Primary

Measure	Time frame
Change in reflux time, reflux duration and symptoms before and after treatment as measured by 24-h oesophageal pH monitoring, questionnairies, patient controle	—

Secondary

Measure	Time frame
Physical examination, growth, laboratory results.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)