A randomized comparison of surfactant dosing via a dual-lumen endotracheal tube in respiratory distress syndrome. The Spanish Surfactant Collaborative Group.
OBJECTIVE
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.


METHODS
Prospective, multicenter, randomized, nonblinded clinical trial.


METHODS
Neonatal intensive care units of the Spanish Surfactant Collaborative Group.


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.


CONCLUSIONS
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.
Valls-i-Soler
A
A
Neonatal Intensive Care Unit, Department of Pediatrics, Hospital de Cruces, Basque University School of Medicine, Bilbao, Bizkaia, Spain.
Fernández-Ruanova
B
B
López-Heredia y Goya
J
J
Román Etxebarría
L
L
Rodriguez-Soriano
J
J
Carretero
V
V
D001688:Biological Products; D001919:Bradycardia / Q000517:prevention & control; D005260:Female; D006801:Humans; D000860:Hypoxia / Q000517:prevention & control; D007231:Infant, Newborn; D007263:Infusions, Parenteral / Q000295:instrumentation; D007442:Intubation, Intratracheal / Q000295:instrumentation; D008297:Male; D010743:Phospholipids; D011446:Prospective Studies; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000150:complications / Q000188:drug therapy* / Q000628:therapy
D001688:Biological Products; D010743:Phospholipids; D011663:Pulmonary Surfactants; C068291:poractant alfa