Effect of hemocoagulase for prevention of pulmonary hemorrhage in critical newborns on mechanical ventilation: a randomized controlled trial.

OBJECTIVE To investigate the role of hemocoagulase to prevent pulmonary hemorrhage in critical newborns on mechanical ventilation. DESIGN Randomized controlled trial. SETTING Neonatal Intensive Care Unit of an affiliated hospital of a Medical University. CHILDREN Seventy-two critical newborn infants on mechanical ventilation. INTERVENTION The involved neonates were divided randomly into two groups. Forty-one patients were treated with prophylactic hemocoagulase(dripped through the endotracheal tube), and other 31 neonates served as controls. OUTCOME MEASURES Incidence of pulmonary hemorrhage, time of ceasing pulmonary hemorrhage if occurred, time of withdrawing of mechanical ventilation in the survivors, and mortality. RESULTS The incidence of pulmonary hemorrhage (12% vs 42%) and the time of ceasing pulmonary hemorrhage (1.36 +/- 0.65 vs 3.58 +/- 0.82, days), were significantly less in infants treated with prophylactic hemocoagulase as compared with the controls (P<0.05). The time to withdrawal of mechanical ventilation was less in the intervention group (3.20 +/- 0.45 vs 5.04 +/- 1.51 days) (P < 0.05). The mortality in children who received hemocoagulase was 22.0%, which was significantly less than controls (41.9 %) (P < 0.05). CONCLUSION Prophylactic use of hemocoagulase in mechanically ventilated neonates is effective against pulmonary hemorrhage.