TY - JOUR
T1 - Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial
AU - Rook, Denise
AU - Schierbeek, Henk
AU - van der Eijk, Anne C.
AU - Longini, Mariangela
AU - Buonocore, Giuseppe
AU - Vento, Maximo
AU - van Goudoever, Johannes B.
AU - Vermeulen, Marijn J.
PY - 2012
Y1 - 2012
N2 - 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
AB - 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
U2 - https://doi.org/10.1186/1745-6215-13-65
DO - https://doi.org/10.1186/1745-6215-13-65
M3 - Article
C2 - 22621326
SN - 1745-6215
VL - 13
SP - 65
JO - Trials
JF - Trials
M1 - 65
ER -