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CURPAP STUDY—AN INTERNATIONAL RANDOMISED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF COMBINING PROPHYLACTIC SURFACTANT AND EARLY NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE IN VERY PRETERM INFANTS: PRELIMINARY RESULTS
  1. R Plavka1,
  2. U Simeoni2,
  3. F Sandri3,
  4. CURPAP Study Group
  1. 1General Faculty Hospital in Prague, Prague, Czech Republic
  2. 2Faculté de Médecine, Université de la Méditerranée and AP-HM, Hopital de la Conception, Marseille, France
  3. 3Ospedale Maggiore; Via Dell’Ospedale, Bologna, Italy

Abstract

Background and Aims Despite measures that enable avoidance of the use of mechanical ventilation (MV), a major factor in the causation of bronchopulmonary dysplasia, there is still a high number of extremely preterm infants who fail on continuous positive airway pressure. The CURPAP study was designed to answer a current question in neonatology: “Is the prophylactic administration of surfactant superior to early rescue treatment in extremely preterm but spontaneously breathing infants supported on nasal continuous positive airway pressure (NCPAP) in reducing the need for MV, during the first five days of life?”.

Methods Preterm neonates with a gestational age of 25 + 0 to 28 + 6 weeks with spontaneous breathing activity were randomly assigned immediately after birth to two groups: group 1, early stabilisation on NCPAP with early rescue surfactant administration according to defined criteria; group 2, intubation, prophylactic surfactant administration shortly after delivery and rapid extubation followed by NCPAP. Surfactant (Curosurf, Chiesi Farmaceutici), in a first dose of 200 mg/kg, was administered in both groups. The immediate extubation to NCPAP after the surfactant administration was recommended as soon as possible but not later than 1 h; further management was the same in both groups. The calculated sample size of 208 infants was stratified according to gestational age to two subgroups (25–26 weeks and 27–28 weeks). The primary outcome, the need for MV during the first 5 days of life, and the other variables regarding neonatal morbidity were statistically calculated and evaluated.

Results A total of 208 infants was enrolled in 24 European neonatal intensive care units. The recruitment was proportional to the gestational age: 25 weeks, 10%; 26 weeks, 22%; 27 weeks, 30% and 28 weeks, 38%. The demographic and clinical characteristics were similar in both groups. The primary outcome and the other variables are being analysed and will be presented.

Conclusion The CURPAP study could give some new information about the respiratory management of this group of extremely immature neonates.

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