COMPARISON OF PROPHYLAXIS AND RESCUE TREATMENT WITH CUROSURF IN NEONATES LESS-THAN 30 WEEKS GESTATION - A RANDOMIZED TRIAL

ABSTRACT. Objective. The aim of this randomized clinical trial was to evaluate the immediate effects of prophylactic administration of Curos urf and to compare outcomes after prophylactic or expectant management . Study design. Porcine surfactant (Curosurf, 200 mg/kg body weight) w as administered intratracheally within 10 minutes of birth to preterm neonates with a gestational age of 26 to 29 weeks (n = 75); rescue-eli gible neonates (n = 72) were initially subjected to a sham maneuver. T he primary end points of the trial, evaluated at the age of 6 hours, w ere to obtain (1) a 40% decrease in the ratio between transcutaneous o xygen tension (tcPO2) (kPa) and fraction of inspired oxygen (FIO2), an d (2) a 50% decrease in the incidence of radiologically verified respi ratory distress syndrome (RDS). After 6 to 24 hours, a similar dose of surfactant was given to the neonates of both the prophylaxis and the rescue-eligible group, if they needed mechanical ventilation with an F IO2 greater-than-or-equal-to 0.6. Results. At 6 hours the prophylaxis group had, in comparison with the rescue-eligible group, significantly higher tCPO2/FIO2 ratios (mean +/- SD: 39.7 +/- 15.3 vs 28.1 +/-18.1; P <.001) and less severe RDS by radiological scoring (chi2 = 14.9; P =.005). Severe RDS was present in 19% of the prophylactically treated neonates versus 32% in the rescue-eligible group (P < .05). The prophy laxis group needed shorter periods of FIO2 > 0.40 than the rescue-elig ible neonates (P < .01), and eight neonates of the prophylaxis group ( 11%) versus 23 of the rescue-eligible group (32%) qualified for rescue treatment with surfactant in the interval 6 to 24 hours (P < .01). Th ere were no differences in the incidence or severity of pneumothorax, pulmonary interstitial emphysema, cerebral hemorrhage, periventricular leukomalacia, patent ductus arteriosus, in the duration of mechanical ventilation or time in supplemental oxygen, or in mortality. Conclusi ons. Subgroup analysis revealed (1) that administration of corticoster oids reduced the risk of developing neonatal RDS as effectively as did surfactant prophylaxis at birth, and (2) that prophylaxis was effecti ve especially in neonates with gestational age <28 weeks or birth weig ht <1000 g, in male neonates, and in neonates who had received no ante natal treatment with corticosteroids. Our data indicate that prophylac tic treatment with surfactant should be considered in high-risk neonat es fulfilling these latter criteria.