A RANDOMIZED COMPARISON OF SURFACTANT DOSING VIA A DUAL-LUMEN ENDOTRACHEAL-TUBE IN RESPIRATORY-DISTRESS SYNDROME

Aim. To determine if 1-minute instillation of Curosurf via a dual-lume n endotracheal tube without interruption of mechanical ventilation cou ld decrease the incidence of hypoxia (drop in oxygen saturation [SaO(2 )] to <80%, or of transcutaneous partial pressure of oxygen [PtCO2] to <50 mm Hg [6.6 kPa]) and bradycardia (heart rate below 80 beats/minut e) at dosing, without affecting the efficacy of the standard bolus del ivery. Design. Prospective, multicenter, randomized, nonblinded clinic al trial. Setting. Neonatal intensive care units of the Spanish Surfac tant Collaborative Group. Patients and Methods. One hundred ninety-eig ht infants (birth weight 600-2000 g) with respiratory distress syndrom e needing mechanical ventilation with a fraction of inspired oxygen [F IO2] greater than or equal to 0.40 were randomized before 24 hours to receive 200 mg/kg of Curosurf, either by bolus instillation (n = 99) o r by a simplified dosing technique (n = 99), giving the full dose in 1 minute via a dual-lumen endotracheal tube without positioning, interr uption of mechanical ventilation, or bagging. Two additional doses (10 0 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 FI O2 greater than or equal to 0.30. The effects of both procedures on th e incidence of acute adverse events at dosing, gas exchange, ventilato r requirements, and outcome at 28 days were compared. Results. Fewer e pisodes of hypoxia (18 vs 40% of doses), and a smaller decrease in hea rt rate and SaO(2) were observed in the dual-lumen group. Efficacy of surfactant, based on improvement of oxygenation, ventilator requiremen ts, and number of doses required, was similar in both groups. Infants in the dual-lumen group had a lower total time exposure to supplementa l oxygen (195 +/- 194 vs 266 +/- 221 hours). No differences in the inc idence of air leaks, intraventricular hemorrhage, patent ductus arteri osus, bronchopulmonary dysplasia, or survival were observed. Conclusio n. A simplified 1-minute Curosurf dosing procedure via a dual-lumen en dotracheal tube without fractional doses, ventilator disconnection, ch anges in the infant's position, or manual bagging was found to reduce the number of dosing-related adverse transient episodes of hypoxia. Al though the simplified method appeared to be as effective as bolus deli very, this should be confirmed in a larger trial.