Comparing omeprazole and ranitidine in treatment of gasteroesophageal reflux disease in pretem neonates
Phase 4
Completed
- Conditions
- Gastroesophageal reflux in premature neonate.Other specified perinatal digestive system disorders
- Registration Number
- IRCT2016030226876N1
- Lead Sponsor
- Investigator
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Healthy preterm infants with troublesome clinical manifestations of gasteroesophageal reflux disease (including wheezing, pneumonia, chronic cough, apnea, stridor, failure to thrive, seizure, anemia, sandifer syndrome, irritability, regurgitation, vomiting, rumination); non-resposive to conservative treatment including antireflux positioning and hypo-allergen regimen.
Exclusion criteria :
Abnormality of GI tract (volvulus, atresia); Drug abuse (morphine, phenobarbital);
Mechanical ventilation; Underlying disease (necrotizing enterocolitis, sepsis); Central nervous system abnormalities; Pripheral nervous system abnormalities, Neuro-muscular abnormalities (Myastenia gravis,Werdnig-Hoffmann disease)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GERD symptomps and signs. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.
- Secondary Outcome Measures
Name Time Method Complications of ranitidine & omeprazole. Timepoint: One week and one month after intervention. Method of measurement: Questionnaire.