title: A multicenter randomized controlled trial comparing effectiveness of two nasal continuous positive airway pressure devices in very-low-birth-weight infants.
abstract: OBJECTIVE
  Many 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.
  
  
  METHODS
  Our 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.
  
  
  METHODS
  Twelve leading tertiary care neonatal centers in Poland.
  
  
  METHODS
  Among 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.
  
  
  RESULTS
  Treatment 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.
  
  
  CONCLUSIONS
  We 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.
authors.affiliation: Neonatal Intensive Care Unit, Medical University of Silesia, Hospital No. 2, Bytom, Poland. bober_k@interia.pl
authors.forename: Klaudiusz
authors.initials: K
authors.lastname: Bober
authors.forename: Janusz
authors.initials: J
authors.lastname: Świetliński
authors.forename: Jan
authors.initials: J
authors.lastname: Zejda
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Kornacka
authors.forename: Dorota
authors.initials: D
authors.lastname: Pawlik
authors.forename: Jakub
authors.initials: J
authors.lastname: Behrendt
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Gajewska
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Czyżewska
authors.forename: Piotr
authors.initials: P
authors.lastname: Korbal
authors.forename: Janusz
authors.initials: J
authors.lastname: Witalis
authors.forename: Wojciech
authors.initials: W
authors.lastname: Walas
authors.forename: Maria
authors.initials: M
authors.lastname: Wilińska
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Turzańska
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Zieliński
authors.forename: Beata
authors.initials: B
authors.lastname: Czeszyńska
authors.forename: Thomas
authors.initials: T
authors.lastname: Bachman
mesh_terms: D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D011044:Poland; D011446:Prospective Studies; D012127:Respiratory Distress Syndrome, Newborn / Q000628:therapy*; D016896:Treatment Outcome