title: Randomized trial of early bubble continuous positive airway pressure for very low birth weight infants.
abstract: OBJECTIVE
  To determine whether very low birth weight infants (VLBWIs), initially supported with continuous positive airway pressure (CPAP) and then selectively treated with the INSURE (intubation, surfactant, and extubation to CPAP; CPAP/INSURE) protocol, need less mechanical ventilation than those supported with supplemental oxygen, surfactant, and mechanical ventilation if required (Oxygen/mechanical ventilation [MV]).
  
  
  METHODS
  In a multicenter randomized controlled trial, spontaneously breathing VLBWIs weighing 800-1500 g were allocated to receive either therapy. In the CPAP/INSURE group, if respiratory distress syndrome (RDS) did not occur, CPAP was discontinued after 3-6 hours. If RDS developed and the fraction of inspired oxygen (FiO(2)) was >0.35, the INSURE protocol was indicated. Failure criteria included FiO(2) >0.60, severe apnea or respiratory acidosis, and receipt of more than 2 doses of surfactant. In the Oxygen/MV group, in the presence of RDS, supplemental oxygen without CPAP was given, and if FiO(2) was >0.35, surfactant and mechanical ventilation were provided.
  
  
  RESULTS
  A total of 256 patients were randomized to either the CPAP/INSURE group (n = 131) or the Oxygen/MV group (n = 125). The need for mechanical ventilation was lower in the CPAP/INSURE group (29.8% vs 50.4%; P = .001), as was the use of surfactant (27.5% vs 46.4%; P = .002). There were no differences in death, pneumothorax, bronchopulmonary dysplasia, and other complications of prematurity between the 2 groups.
  
  
  CONCLUSIONS
  CPAP and early selective INSURE reduced the need for mechanical ventilation and surfactant in VLBWIs without increasing morbidity and death. These results may be particularly relevant for resource-limited regions.
authors.affiliation: Department of Pediatrics, Pontificia Universidad Catolica de Chile, Santiago, Chile. jlta@med.puc.cl
authors.forename: Jose L
authors.initials: JL
authors.lastname: Tapia
authors.forename: Soledad
authors.initials: S
authors.lastname: Urzua
authors.forename: Aldo
authors.initials: A
authors.lastname: Bancalari
authors.forename: Javier
authors.initials: J
authors.lastname: Meritano
authors.forename: Gabriela
authors.initials: G
authors.lastname: Torres
authors.forename: Jorge
authors.initials: J
authors.lastname: Fabres
authors.forename: Claudia A
authors.initials: CA
authors.lastname: Toro
authors.forename: Fabiola
authors.initials: F
authors.lastname: Rivera
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Cespedes
authors.forename: Jaime F
authors.initials: JF
authors.lastname: Burgos
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Mariani
authors.forename: Liliana
authors.initials: L
authors.lastname: Roldan
authors.forename: Fernando
authors.initials: F
authors.lastname: Silvera
authors.forename: Agustina
authors.initials: A
authors.lastname: Gonzalez
authors.forename: Angelica
authors.initials: A
authors.lastname: Dominguez
mesh_terms: D045422:Continuous Positive Airway Pressure / Q000379:methods*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D008297:Male