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. 2019 Jul 2;2019(7):CD011785. doi: 10.1002/14651858.CD011785.pub2

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.
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
  1. Duration of gastric bleeding.

  2. Mortality.

Notes Conflicts of interest: not reported.
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) 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.