AIM: To determine if 1-minute instillation of Curosurf via a dual-lumen endotracheal tube without interruption of mechanical ventilation could decrease the incidence of hypoxia (drop in oxygen saturation [SaO2] to <80%, or of transcutaneous partial pressure of oxygen [PtcO2] to <50 mm Hg [6.6 kPa]) and bradycardia (heart rate below 80 beats/minute) at dosing, without affecting the efficacy of the standard bolus delivery. DESIGN: Prospective, multicenter, randomized, nonblinded clinical trial. SETTING:Neonatal intensive care units of the Spanish Surfactant Collaborative Group. PATIENTS AND METHODS: One hundred ninety-eight infants (birth weight 600-2000 g) with respiratory distress syndrome needing mechanical ventilation with a fraction of inspired oxygen [FIO2] 0.40 were randomized before 24 hours to receive 200 mg/kg of Curosurf, either by bolus instillation (n = 99) or by a simplified dosing technique (n = 99), giving the full dose in 1 minute via a dual-lumen endotracheal tube without positioning, interruption of mechanical ventilation, or bagging. Two additional doses (100 mg/kg) were given within 12 and 24 hours of first dose, by the same method, if the infant still needed mechanical ventilation and had a FIO2 0.30. The effects of both procedures on the incidence of acute adverse events at dosing, gas exchange, ventilator requirements, and outcome at 28 days were compared. RESULTS: Fewer episodes of hypoxia (18 vs 40% of doses), and a smaller decrease in heart rate and SaO2 were observed in the dual-lumen group. Efficacy of surfactant, based on improvement of oxygenation, ventilator requirements, and number of doses required, was similar in both groups. Infants in the dual-lumen group had a lower total time exposure to supplemental oxygen (195+/-199 vs 266+/-221 hours). No differences in the incidence of air leaks, intraventricular hemorrhage, patent ductus arteriosus, bronchopulmonary dysplasia, or survival were observed. CONCLUSION: A simplified 1-minute Curosurf dosing procedure via a dual-lumen endotracheal tube without fractional doses, ventilator disconnection, changes in the infant's position, or manual bagging was found to reduce the number of dosing-related adverse transient episodes of hypoxia. Although the simplified method appeared to be as effective as bolus delivery, this should be confirmed in a larger trial.
RCT Entities:
AIM: To determine if 1-minute instillation of Curosurf via a dual-lumen endotracheal tube without interruption of mechanical ventilation could decrease the incidence of hypoxia (drop in oxygen saturation [SaO2] to <80%, or of transcutaneous partial pressure of oxygen [PtcO2] to <50 mm Hg [6.6 kPa]) and bradycardia (heart rate below 80 beats/minute) at dosing, without affecting the efficacy of the standard bolus delivery. DESIGN: Prospective, multicenter, randomized, nonblinded clinical trial. SETTING: Neonatal intensive care units of the Spanish Surfactant Collaborative Group. PATIENTS AND METHODS: One hundred ninety-eight infants (birth weight 600-2000 g) with respiratory distress syndrome needing mechanical ventilation with a fraction of inspired oxygen [FIO2] 0.40 were randomized before 24 hours to receive 200 mg/kg of Curosurf, either by bolus instillation (n = 99) or by a simplified dosing technique (n = 99), giving the full dose in 1 minute via a dual-lumen endotracheal tube without positioning, interruption of mechanical ventilation, or bagging. Two additional doses (100 mg/kg) were given within 12 and 24 hours of first dose, by the same method, if the infant still needed mechanical ventilation and had a FIO2 0.30. The effects of both procedures on the incidence of acute adverse events at dosing, gas exchange, ventilator requirements, and outcome at 28 days were compared. RESULTS: Fewer episodes of hypoxia (18 vs 40% of doses), and a smaller decrease in heart rate and SaO2 were observed in the dual-lumen group. Efficacy of surfactant, based on improvement of oxygenation, ventilator requirements, and number of doses required, was similar in both groups. Infants in the dual-lumen group had a lower total time exposure to supplemental oxygen (195+/-199 vs 266+/-221 hours). No differences in the incidence of air leaks, intraventricular hemorrhage, patent ductus arteriosus, bronchopulmonary dysplasia, or survival were observed. CONCLUSION: A simplified 1-minute Curosurf dosing procedure via a dual-lumen endotracheal tube without fractional doses, ventilator disconnection, changes in the infant's position, or manual bagging was found to reduce the number of dosing-related adverse transient episodes of hypoxia. Although the simplified method appeared to be as effective as bolus delivery, this should be confirmed in a larger trial.