Han 2001.
Methods | Clinical trial in China. | |
Participants |
Inclusion criteria: newborns age 1 to 12 days. Most infants with severe illness. Term and preterm. Exclusion criteria: if swallowed maternal blood, bleeding outside gastrointestinal tract, abnormal clotting, constipation, necrotising enterocolitis. |
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Interventions |
Intervention (n = 43): cimetidine 5 mg/kg per day for 5 days. Control (n = 40): no cimetidine. |
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Outcomes | Acute gastric mucosal lesion (diagnosed by vomiting of bright red or coffee‐like liquid or faecal occult blood positive or tarry stool). | |
Notes | Authors did not believe there were any adverse reactions attributable to the intervention. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported 'random'. |
Allocation concealment (selection bias) | Unclear risk | Method not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None reported. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Low risk | Similar baseline characteristics between groups. |