• Pediatr Crit Care Me · Mar 2012

    Randomized Controlled Trial Multicenter Study Comparative Study

    A multicenter randomized controlled trial comparing effectiveness of two nasal continuous positive airway pressure devices in very-low-birth-weight infants.

    • Klaudiusz Bober, Janusz Świetliński, Jan Zejda, Katarzyna Kornacka, Dorota Pawlik, Jakub Behrendt, Elżbieta Gajewska, Małgorzata Czyżewska, Piotr Korbal, Janusz Witalis, Wojciech Walas, Maria Wilińska, Agnieszka Turzańska, Grzegorz Zieliński, Beata Czeszyńska, and Thomas Bachman.
    • Neonatal Intensive Care Unit, Medical University of Silesia, Hospital No. 2, Bytom, Poland. bober_k@interia.pl
    • Pediatr Crit Care Me. 2012 Mar 1;13(2):191-6.

    ObjectiveMany studies suggest nasal continuous positive airway pressure is an effective and relatively complication-free means of respiratory support in premature infants. However, only limited data exist regarding the practical aspects of nasal continuous positive airway pressure delivery, including the best way to provide the positive airway pressure.DesignOur aim was to compare the results of treatment using two different nasal continuous positive airway pressure devices: variable flow Infant Flow and constant flow nasal continuous positive airway pressure in two different groups of very-low-birth-weight infants in a multicenter randomized controlled trial. The indication groups were elective to avoid intubation and weaning from mechanical ventilation.SettingTwelve leading tertiary care neonatal centers in Poland.PatientsAmong 276 infants (weighing between 750-1500g, with a gestational age ≤32 wks) enrolled, 51% were randomized to receive Infant Flow and 49% to receive constant flow nasal continuous positive airway pressure.Measurements And Main ResultsTreatment success (i.e., no need for intubation/reintubation) occurred in 75% of our patients with a nonstatistically significant advantage seen with Infant Flow. The incidence of severe nasal complications and necrotizing enterocolitis were statistically significantly lower in the infants treated with Infant Flow. In our study, factors associated with elective nasal continuous positive airway pressure failure were birth weight ≤1000 g, gestational age ≤28 wks, clinical risk index for babies score >1, and PaO(2)/FIO(2) ratio of <150. Only birth weight ≤1000 g was associated with weaning failure.ConclusionsWe found fewer severe nasal complications but no statistically significant advantage in treatment success in infants assigned to Infant Flow nasal continuous positive airway pressure compared with those assigned to constant flow nasal continuous positive airway pressure treatment. Significant risk factors of treatment failure include small size, maturity, and severity of respiratory distress syndrome.

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