Lu 1995.
Methods | Randomised controlled trial in China January 1990 to October 1992. | |
Participants |
Inclusion criteria: sick term and preterm newborns at high risk of gastric bleeding. Exclusion criteria: none reported. |
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Interventions |
Intervention (n = 56): cimetidine 5 mg/kg/dose intravenously in 10% glucose twice daily for 3 to 5 days. Control (n = 62): no treatment. All infants given vitamin K 5 mg/day [route not reported] for 3 days. |
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Outcomes |
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Notes | Authors did not believe there were any adverse reactions attributable to the intervention. It was unclear how bleeding time was determined, given that these infants did not have bleeding initially. As a result, it could not be included in the 'duration of upper gastrointestinal bleeding in infants with upper gastrointestinal bleeding (days)' outcome. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported: "randomly assigned". |
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 | Unclear risk | Similar baseline characteristics between groups. |