PEDIATRICS Vol. 101 No. 4 April 1998, p. e4
Received Jul 28, 1997; accepted Dec 11, 1997.
,
From the * Neonatal Division and
Research Unit, and the
§ Department of Pediatrics, Hospital de Cruces, Osakidetza, Basque
University School of Medicine, Bilbao, Bizkaia, Spain.
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.
Key words: Curosurf, drug administration, prematurity, pulmonary surfactant, respiratory distress syndrome.