RT Journal Article
SR Electronic
T1 Randomized European Multicenter Trial of Surfactant Replacement Therapy for Severe Neonatal Respiratory Distress Syndrome: Single Versus Multiple Doses of Curosurf
JF Pediatrics
JO Pediatrics
FD American Academy of Pediatrics
SP 13
OP 20
VO 89
IS 1
A1 Speer, Christian P.
A1 Robertson, Bengt
A1 Curstedt, Tore
A1 Halliday, Henry L.
A1 Compagnone, Daniele
A1 Gefeller, Olaf
A1 Harms, Karsten
A1 Herting, Egbert
A1 McClure, Garth
A1 Reid, Marc
A1 Tubman, Richard
A1 Herin, Peter
A1 Noack, Gerd
A1 Kok, Joke
A1 Koppe, Janna
A1 van Sonderen, Loekie
A1 Laufkötter, Edgar
A1 Köhler, Wolfgang
A1 Boenisch, Herbert
A1 Albrecht, Klaus
A1 Hanssler, Ludwig
A1 Haim, Michaela
A1 Oetomo, Sidarto B.
A1 Okken, Albert
A1 Altfeld, Peter C.
A1 Groneck, Peter
A1 Kachel, Walter
A1 Relier, Jean-Pierre
A1 Walti, Herve
YR 1992
UL http://pediatrics.aappublications.org/content/89/1/13.abstract
AB There is now convincing evidence that the severity of neonatal respiratory distress syndrome can be reduced by surfactant replacement therapy; however, the optimal therapeutic regimen has not been defined. This randomized European multicenter trial was designed to determine whether the beneficial effects of a single large dose of Curosurf (200 mg/kg) in babies with severe respiratory distress syndrome (arterial to alveolar oxygen tension ratio ∼0.10) could be enhanced by using multiple doses of surfactant. Preterm neonates (birth weight 700 to 2000 g) with severe respiratory distress syndrome requiring artificial ventilation with fraction of inspired oxygen ≥0.6 were randomized into two groups at an age of 2 to 15 hours. Both groups received the usual dose of Curosurf(200 mg/kg) immediately after randomization. In neonates randomized to receive multiple-dose treatment, two additional doses of Curosurf (100 mg/kg each) were instilled into the airways (12 and 24 hours after the initial dose) provided that the patients still needed artificial ventilation with fraction of inspired oxygen >0.21. In both groups (single dose: n = 176, multiple doses: n = 167) there was a rapid improvement in oxygenation as reflected by a threefold increase in arterial to alveolar oxygen tension ratio within 5 minutes after surfactant instillation (P < .001), and peak inspiratory pressure and mean airway pressure could be reduced significantly during the first 6 hours after surfactant treatment. In addition, ventilatory requirement (peak inspiratory pressure, ventilatory efficiency index) was reduced in the multiple-dose group 2 to 4 days after randomization (P < .05 to .01). Sixty-five percent of the patients randomized to the multiple-dose regimen and 68% of the single-dose group needed supplemental oxygen 12 hours after the first treatment. Analysis of 28-day outcome data showed a reduction of the incidence of pneumothorax in the multiple-dose group (9% vs 18%, P < .01). The primary end point, of combined incidence of mortality and bronchopulmonary dysplasia, was 33% in the single-dose group and 27% in the multiple-dose group (P = .08). Mortality at 28 days was reduced from 21% in the single-dose group to 13% in the multiple-dose group (P < .05 by logistic regression). It is concluded that treatment with multiple doses of surfactant is more effective than single-dose treatment in severe neonatal respiratory distress syndrome, further reducing pneumothorax mortality.