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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 obj...

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Autores principales: Rook, Denise, Schierbeek, Henk, van der Eijk, Anne C, Longini, Mariangela, Buonocore, Giuseppe, Vento, Maximo, van Goudoever, Johannes B, Vermeulen, Marijn J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474149/
https://www.ncbi.nlm.nih.gov/pubmed/22621326
http://dx.doi.org/10.1186/1745-6215-13-65
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author Rook, Denise
Schierbeek, Henk
van der Eijk, Anne C
Longini, Mariangela
Buonocore, Giuseppe
Vento, Maximo
van Goudoever, Johannes B
Vermeulen, Marijn J
author_facet Rook, Denise
Schierbeek, Henk
van der Eijk, Anne C
Longini, Mariangela
Buonocore, Giuseppe
Vento, Maximo
van Goudoever, Johannes B
Vermeulen, Marijn J
author_sort Rook, Denise
collection PubMed
description 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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spelling pubmed-34741492012-10-23 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 Trials Study Protocol 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. BioMed Central 2012-05-23 /pmc/articles/PMC3474149/ /pubmed/22621326 http://dx.doi.org/10.1186/1745-6215-13-65 Text en Copyright ©2012 Rook et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Rook, Denise
Schierbeek, Henk
van der Eijk, Anne C
Longini, Mariangela
Buonocore, Giuseppe
Vento, Maximo
van Goudoever, Johannes B
Vermeulen, Marijn J
Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
title Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
title_full Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
title_fullStr Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
title_full_unstemmed Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
title_short Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
title_sort resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474149/
https://www.ncbi.nlm.nih.gov/pubmed/22621326
http://dx.doi.org/10.1186/1745-6215-13-65
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