title: Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Resuscitation at birth with 100% oxygen is known to increase the oxidative burden with concomitant deleterious effects. Although fractions of inspired oxygen (FiO₂) < 100% are widely used in preterm infants, starting resuscitation at a (too) low FiO₂ may result in hypoxia. The objective of this study is to compare the safety and efficacy of resuscitating very preterm infants with an initial FiO2 of 30% versus 65%.
  
  
  METHODS
  In this double-blind, randomized controlled trial, 200 very preterm infants with a gestational age < 32 weeks will be randomized to start resuscitation after birth with either 30% or 65% oxygen. The FiO₂ will be adjusted based on oxygen saturation measured by pulse oximetry (SpO₂) and pulse rate (which should be over 100 beats per minute) in order to achieve a target SpO₂ of 88-94% at 10 min of life. The FiO₂ and pulse oximetry data will be continuously recorded.The primary outcome is survival without bronchopulmonary dysplasia, as assessed by a physiological test at 36 weeks postmenstrual age. The secondary outcomes include the time to achieve SpO₂ > 88%, Apgar score at 5 min, cumulative O₂ exposure, oxidative stress (as determined by glutathione synthesis and oxidative stress markers), retinopathy of prematurity, brain injury and neurodevelopmental outcome at 2 years of age.This study will provide insight into determining the appropriate initial FiO₂ to start resuscitation of very preterm infants.
  
  
  BACKGROUND
  http://www.trialregister.nl, NTR243.
authors.affiliation: Department of Pediatrics, Division of Neonatology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.
authors.forename: Denise
authors.initials: D
authors.lastname: Rook
authors.forename: Henk
authors.initials: H
authors.lastname: Schierbeek
authors.forename: Anne C
authors.initials: AC
authors.lastname: van der Eijk
authors.forename: Mariangela
authors.initials: M
authors.lastname: Longini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Buonocore
authors.forename: Maximo
authors.initials: M
authors.lastname: Vento
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Goudoever
authors.forename: Marijn J
authors.initials: MJ
authors.lastname: Vermeulen
mesh_terms: D001034:Apgar Score; D001930:Brain Injuries / Q000209:etiology; D001997:Bronchopulmonary Dysplasia / Q000209:etiology; D002657:Child Development; D004311:Double-Blind Method; D005865:Gestational Age; D006339:Heart Rate; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D015931:Intensive Care, Neonatal / Q000379:methods*; D009426:Netherlands; D018384:Oxidative Stress; D010092:Oximetry; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects / Q000379:methods*; D012107:Research Design; D012151:Resuscitation / Q000009:adverse effects / Q000379:methods*; D012178:Retinopathy of Prematurity / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome