Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
1 Department of Pediatrics, Division of Neonatology, Erasmus Medical Center - Sophia Children’s Hospital, Rotterdam, The Netherlands
2 Department of BioMechanical Engineering, Faculty of Mechanical, Maritime & Materials Engineering, Delft University of Technology, Delft, The Netherlands
3 Department of Pediatrics, Obstetrics and Reproductive Medicine, University of Siena, Siena, Italy
4 Department of Pediatrics, Division of Neonatology, University Children’s Hospital La Fe, Valencia, Spain
5 Department of Pediatrics, Emma Children’s Hospital - AMC, Amsterdam, The Netherlands
6 Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands
Trials 2012, 13:65 doi:10.1186/1745-6215-13-65Published: 23 May 2012
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%.
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.