Denise Rook1, Henk Schierbeek2, Maximo Vento3, Hester Vlaardingerbroek1, Anne C van der Eijk4, Mariangela Longini5, Giuseppe Buonocore5, Javier Escobar6, Johannes B van Goudoever7, Marijn J Vermeulen1. 1. Department of Pediatrics, Division of Neonatology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands. 2. Department of Pediatrics, Academic Medical Center-Emma Children's Hospital, Amsterdam, The Netherlands. 3. Division of Neonatology, La Fe University and Polytechnic Hospital, Valencia, Spain; Neonatal Research Unit, La Fe Health Research Institute, Valencia, Spain. 4. Department of Pediatrics, Division of Neonatology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands; Department of Biomechanical Engineering, Faculty of Mechanical, Maritime, and Materials Engineering, Delft University of Technology, Delft, The Netherlands. 5. Department of Pediatrics, Obstetrics, and Reproductive Medicine, University of Siena, Siena, Italy. 6. Neonatal Research Unit, La Fe Health Research Institute, Valencia, Spain. 7. Department of Pediatrics, Academic Medical Center-Emma Children's Hospital, Amsterdam, The Netherlands; Department of Pediatrics, VU University Medical Centre, Amsterdam, The Netherlands. Electronic address: h.vangoudoever@amc.uva.nl.
Abstract
OBJECTIVE: To test the hypothesis that an initial fraction of inspired oxygen (FiO2) of 30% during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with an FiO2 of 65%. STUDY DESIGN:Preterm infants of gestational age <32 weeks (n = 193) were randomized to start resuscitation with either 30% oxygen (low-oxygen group) or 65% oxygen (high-oxygen group), after which the FiO2 was adjusted based on oxygen saturation values. The primary outcome was bronchopulmonary dysplasia (BPD) assessed at 36 weeks postmenstrual age. Secondary outcomes included major neonatal illnesses and markers of oxidative stress. RESULTS: The median gestational age of included infants was 28(6)/7 weeks (IQR, 26(5)/7-30(3)/7 weeks). The incidence of BPD was not significantly different between the low-oxygen and high-oxygen groups (24% vs. 17%; P = .15). The FiO2 in both groups was adjusted to a mean of 40% by 7 minutes in the low-oxygen group and by 11 minutes in the high-oxygen group. No differences in markers of oxidative stress were noted between groups. CONCLUSION: Initial supplementation of preterm infants with 30% oxygen during the fetal-to-neonatal transition is as safe as 65% oxygen, with no differences in oxidative stress markers or BPD.
RCT Entities:
OBJECTIVE: To test the hypothesis that an initial fraction of inspired oxygen (FiO2) of 30% during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with an FiO2 of 65%. STUDY DESIGN: Preterm infants of gestational age <32 weeks (n = 193) were randomized to start resuscitation with either 30% oxygen (low-oxygen group) or 65% oxygen (high-oxygen group), after which the FiO2 was adjusted based on oxygen saturation values. The primary outcome was bronchopulmonary dysplasia (BPD) assessed at 36 weeks postmenstrual age. Secondary outcomes included major neonatal illnesses and markers of oxidative stress. RESULTS: The median gestational age of included infants was 28(6)/7 weeks (IQR, 26(5)/7-30(3)/7 weeks). The incidence of BPD was not significantly different between the low-oxygen and high-oxygen groups (24% vs. 17%; P = .15). The FiO2 in both groups was adjusted to a mean of 40% by 7 minutes in the low-oxygen group and by 11 minutes in the high-oxygen group. No differences in markers of oxidative stress were noted between groups. CONCLUSION: Initial supplementation of preterm infants with 30% oxygen during the fetal-to-neonatal transition is as safe as 65% oxygen, with no differences in oxidative stress markers or BPD.
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