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.
RCT Entities:
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.