Open Access Study protocol

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

Denise Rook1, Henk Schierbeek1, Anne C van der Eijk1,2, Mariangela Longini3, Giuseppe Buonocore3, Maximo Vento4, Johannes B van Goudoever5,6* and Marijn J Vermeulen1

Author Affiliations

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

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Trials 2012, 13:65 doi:10.1186/1745-6215-13-65

Published: 23 May 2012

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/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 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.

Trial registration

http://www.trialregister.nl webcite, NTR243.

Keywords:
Preterm infants; Resuscitation; Oxygen; Bronchopulmonary dysplasia; Oxidative stress; Glutathione synthesis