Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: Study protocol for a randomized controlled trial

Background: Resuscitation at birth with 100% oxygen is known to increase the oxidative burden with concomitant deleterious effects. Although fractions of inspired oxygen (FiO 2) < 100% are widely used in preterm infants, starting resuscitation at a (too) low FiO 2 may result in hypoxia. The objective of this study is to compare the safety and efficacy of resuscitating very preterm infants with an initial FiO 2 of 30% versus 65%.Methods/design: 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 FiO 2 will be adjusted based on oxygen saturation measured by pulse oximetry (SpO 2) and pulse rate (which should be over 100 beats per minute) in order to achieve a target SpO 2 of 88-94% at 10 min of life. The FiO 2 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 SpO 2 > 88%, Apgar score at 5 min, cumulative O 2 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 FiO 2 to start resuscitation of very preterm infants.Trial registration: http://www.trialregister.nl, NTR243.

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