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

Rook, Denise; Schierbeek, Henk; van der Eijk, Anne C; Longini, Mariangela; Buonocore, Giuseppe; Vento, Maximo; van Goudoever, Johannes B; Vermeulen, Marijn J

BACKGROUND Resuscitation at birth with 100% oxygen is known to increase the oxidative burden with concomitant deleterious effects. Although fractions of inspired oxygen (FiOâ‚‚) < 100% are widely used in preterm infants, starting resuscitation at a (too) low FiOâ‚‚ 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/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 FiOâ‚‚ will be adjusted based on oxygen saturation measured by pulse oximetry (SpOâ‚‚) and pulse rate (which should be over 100 beats per minute) in order to achieve a target SpOâ‚‚ of 88-94% at 10 min of life. The FiOâ‚‚ 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 SpOâ‚‚ > 88%, Apgar score at 5 min, cumulative Oâ‚‚ 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 FiOâ‚‚ to start resuscitation of very preterm infants. TRIAL REGISTRATION http://www.trialregister.nl, NTR243.