The comparison of the efficacy of two different doses of lansoprazole in the treatment of gastroesophageal reflux disease in term neonates.
Phase 2
- Conditions
- Gastroesophageal Reflux.Gastro-oesophageal reflux disease
- Registration Number
- IRCT20160827029535N9
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Healthy term neonates aged 1–30days with GERD not responding to conservative therapy (including anti-reflux positioning, milk thickening and feeding with lower volume of milk and shorter interval).
Exclusion Criteria
1-Neonates with any underlying diseases, including anomalies or gastrointestinal obstruction, neurological disorders, sepsis, NEC, etc.2-Using any sedative , relaxant or anticonvulsive medications .3-History of ventilation therapy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The comparison of two different doses of lansoprazole in treatment of refractory neonatal GERD to conservative therapy. Timepoint: One week and one month after using each drug. Method of measurement: using (I-GERDQ-R) and related scoring.
- Secondary Outcome Measures
Name Time Method The side effects of each dose of lansoprazole. Timepoint: After one week and one month of administration. Method of measurement: Clinical manifestations.