Two RCTs were included in the review (120 infants). The authors could not combine results from both studies for analysis because one trial (48 infants) used haemocoagulase an active treatment and the other (72 infants) focused on haemocoagulase as a prophylactic treatment. The included studies were poor quality due to unclear randomisation, allocation concealment, blinding and outcome measure.
Active treatment: The trial reported that preterm infants in the haemocoagulase therapy group had a 48% reduction in mortality compared to the control group (RR 0.52, 95% CI 0.31 to 0.89). The absolute risk reduction for mortality was 35.7%. Three preterm infants would need to be treated with haemocoagulase to save one life. Compared to the control group, results showed shorter duration of pulmonary haemorrhage (WMD -1.74, 95% CI -2.22 to -1.26) and a shorter period required for ventilation (WMD -1.55, 95% CI -2.07 to -1.03) with haemocoagulase therapy.
Prophylaxis: No statistically significant difference of mortality was found between haemocoagulase and control groups. Analyses showed that infants in haemocoagulase had a shorter duration of pulmonary haemorrhage (WMD -2.22, 95% CI -2.57 to -1.87) and shorter period required for ventilation (WMD -1.84, 95% CI -2.39 to -1.29) compared to the control group.
There were no significant differences between haemocoagulase and controls in both trials for incidence of respiratory distress syndrome, perinatal asphyxia, intracranial haemorrhage, patent ductus arteriosus, bronchopulmonary dysplasia, pneumonia, sepsis and the number of infants who received surfactant.