Gastro-oesophageal reflux disease. Gastro-oesophageal reflux disease with oesophagitis
Conditions
Interventions
Intervention 1: omeprazole granules for suspension approximately 1.2mg /kg/ day (5 mg/day for infants 2.5 kg to <7 kg, or 10 mg/day for infants 7kg to 15 kg) for 8 weeks. (Omeprazole is from Chemi dar
Treatment - Drugs
omeprazole granules for suspension approximately 1.2mg /kg/ day (5 mg/day for infants 2.5 kg to <7 kg, or 10 mg/day for infants 7kg to 15 kg) for 8 weeks. (Omeprazole is from Chemi daru pharmaceutical
syrup of ranitidine by dose 2-4mg/kg/day divided in two doses (ranitidine is from Chemi daru pharmaceutical company).
Sponsors
Tabriz university of medical sciences
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Infants 2-12 months with body weight over 2.5 kg and full term pregnancy, who had GERD. Exclusion Criteria: Children with previous gastrointestinal surgery, neurologic disease, significant hepatic or renal impairment or a history of significant cardiac or respiratory disease, a history of peptic ulcer disease, proven lactose intolerance, or cow’s milk protein intolerance; All children hadn’t parental reassurance, use antacids, H2-antagonists, and proton pump inhibitors [PPIs] 4 week before study were excluded.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly GERD symptom score (WGSS). Timepoint: during 2 weeks. Method of measurement: sum of the 5 selected individual weekly GERD symptom mean frequencies for vomiting/regurgitation (1a), irritability/fussiness (2b), choking/gagging (3a), arching back (4a), and refusal to feed (higher score of 5a and 5b). | — |
Secondary
| Measure | Time frame |
|---|---|
| Lack of efficacy per withdrawal criteria, growth parameter. Timepoint: week 4-8. Method of measurement: withdrawal for any reason, time to withdrawal due to lack of efficacy, time to withdrawal for any reason, weekly GERD symptom score (WGSS) ,Physical examinations. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mandana Rafeey
Tabriz university of medical sciences
Outcome results
None listed