Sarna 1991.
Methods | Quasi‐randomised controlled trial January 1990 to July 1990. | |
Participants |
Inclusion criteria: neonates with gastric bleeding Exclusion criteria: all neonates who were septicaemic, preterm, had prolonged prothrombin time or developed disseminated intravascular coagulation. Further information regarding participants: 48 term neonates mean gestational age: ranitidine group 38.3 ± 2.2 weeks versus control group 38.6 ± 2.2 weeks (P > 0.05). Mean birth weight: ranitidine group 2.4 ± 0.6 versus control group 2.6 ± 0.8 kg. |
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Interventions | Intervention (n = 20): ranitidine: 0.6 mg/kg loading dose followed by 0.15 mg/kg/hour intravenous infusion until bleeding had ceased for 24 hours. Control (n = 18): supportive therapy. | |
Outcomes |
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Notes | Conflicts of interest: not reported. Authors did not believe there were any adverse reactions attributable to the intervention. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Reported: "The neonates with gastric bleeding were alternatively, divided into two groups, on the basis of odd and even admission numbers." Quasi‐random allocation. |
Allocation concealment (selection bias) | High risk | The methods of allocation concealment were not specified and the study was quasi‐random. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of assessors not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 (4 treatment group, 6 control) of 48 infants (21%) not reported for other clinical outcomes who died. 3 infants died after intracranial haemorrhage; 3 from hypoxic‐ischaemic encephalopathy; and 4 from respiratory distress syndrome. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
Other bias | Low risk | Infant characteristics were similar between intervention and control groups. |