PROspective Meta-analysis Of Trials of Initial Oxygen in preterm Newborns (PROMOTION): Protocol for a systematic review and prospective meta-analysis with individual participant data on initial oxygen concentration for resuscitation of preterm infants.
individual participant data meta-analysis
neonatal resuscitation
oxygen concentration
preterm birth
prospective meta-analysis
Journal
Acta paediatrica (Oslo, Norway : 1992)
ISSN: 1651-2227
Titre abrégé: Acta Paediatr
Pays: Norway
ID NLM: 9205968
Informations de publication
Date de publication:
03 2023
03 2023
Historique:
revised:
15
11
2022
received:
16
09
2022
accepted:
08
12
2022
pubmed:
10
12
2022
medline:
14
2
2023
entrez:
9
12
2022
Statut:
ppublish
Résumé
Clinicians favour low oxygen concentrations when resuscitating preterm infants immediately after birth despite inconclusive evidence to support this practice. Prospective meta-analysis (PMA) is a novel approach where studies are identified as eligible for inclusion in the meta-analysis before their results are known. To explore whether high (60%) or low (30%) oxygen is associated with greater efficacy and safety for the initial resuscitation (immediately after birth) of preterm infants born at <29 weeks' gestation. We will conduct a prospective meta-analysis (PMA) with individual participant data (IPD). We will perform a systematic search to identify ongoing RCTs including infants <29 weeks' gestation randomised to high (60%) or low (30%) oxygen for initial resuscitation after birth. IPD will be sought for all infants randomised for the purpose of meta-analysis. We will employ a one-stage random-effects approach to IPD meta-analysis. Potential heterogeneity and the differential effect of high or low oxygen will be explored through subgroup and interaction analyses. The primary outcome of this study is all-cause mortality prior to hospital discharge. There will be a follow-up analysis of neurodevelopmental outcomes once available. The results of neonatal outcomes at hospital discharge are expected by 2025, and neurodevelopmental outcomes by 2027.
Sections du résumé
BACKGROUND
Clinicians favour low oxygen concentrations when resuscitating preterm infants immediately after birth despite inconclusive evidence to support this practice. Prospective meta-analysis (PMA) is a novel approach where studies are identified as eligible for inclusion in the meta-analysis before their results are known.
AIMS
To explore whether high (60%) or low (30%) oxygen is associated with greater efficacy and safety for the initial resuscitation (immediately after birth) of preterm infants born at <29 weeks' gestation.
METHODS
We will conduct a prospective meta-analysis (PMA) with individual participant data (IPD). We will perform a systematic search to identify ongoing RCTs including infants <29 weeks' gestation randomised to high (60%) or low (30%) oxygen for initial resuscitation after birth. IPD will be sought for all infants randomised for the purpose of meta-analysis. We will employ a one-stage random-effects approach to IPD meta-analysis. Potential heterogeneity and the differential effect of high or low oxygen will be explored through subgroup and interaction analyses. The primary outcome of this study is all-cause mortality prior to hospital discharge. There will be a follow-up analysis of neurodevelopmental outcomes once available.
RESULTS/CONCLUSION
The results of neonatal outcomes at hospital discharge are expected by 2025, and neurodevelopmental outcomes by 2027.
Substances chimiques
Oxygen
S88TT14065
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
372-382Subventions
Organisme : CIHR
ID : 426498
Pays : Canada
Organisme : National Health and Medical Research Council
ID : GNT 2009432
Organisme : CIHR
ID : 426498
Pays : Canada
Informations de copyright
© 2022 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.
Références
Obladen M. History of neonatal resuscitation - part 2: oxygen and other drugs. Neonatology. 2009;95(1):91-96. doi:10.1159/000151761
Vento M, Moro M, Escrig R, et al. Preterm resuscitation with low oxygen causes less oxidative stress, inflammation, and chronic lung disease. Pediatrics. 2009;124(3):e439-e449. doi:10.1542/peds.2009-0434
Torres-Cuevas I, Parra-Llorca A, Sánchez-Illana A, et al. Oxygen and oxidative stress in the perinatal period. Redox Biol. 2017;12:674-681. doi:10.1016/j.redox.2017.03.011
Vento M, Asensi M, Sastre J, et al. Hyperoxemia caused by resuscitation with pure oxygen may alter intracellular redox status by increasing oxidized glutathione in asphyxiated newly born infants. Semin Perinatol. 2002;26(6):406-410. doi:10.1053/sper.2002.37312
Vento M, Asensi M, Sastre J, Garcı́a-Sala F, Pallardó FV, Viña J. Resuscitation with room air instead of 100% oxygen prevents oxidative stress in moderately asphyxiated term neonates. Pediatrics. 2001;107(4):642-647. doi:10.1542/peds.107.4.642
Saugstad OD, Ramji S, Irani SF, et al. Resuscitation of newborn infants with 21% or 100% oxygen: follow-up at 18 to 24 months. Pediatrics. 2003;112(2):296-300. doi:10.1542/peds.112.2.296
Saugstad OD, Rootwelt T, Aalen O. Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study. Pediatrics. 1998;101:e1. doi:10.1542/peds.102.1.e1
Ramji S, Ahuja S, Thirupuram S, Rootwelt T, Rooth G, Saugstad OD. Resuscitation of Asphyxic newborn infants with room air or 100% oxygen. Pediatr Res. 1993;34(6):809-812. doi:10.1203/00006450-199312000-00023
Davis PG, Tan A, O'Donnell CPF, Schulze A. Resuscitation of newborn infants with 100% oxygen or air: a systematic review and meta-analysis. Lancet. 2004;364(9442):1329-1333. doi:10.1016/S0140-6736(04)17189-4
Rabi Y, Rabi D, Yee W. Room air resuscitation of the depressed newborn: a systematic review and meta-analysis. Resuscitation. 2007;72(3):353-363. doi:10.1016/j.resuscitation.2006.06.134
Saugstad OD, Ramji S, Soll RF, Vento M. Resuscitation of newborn infants with 21% or 100% oxygen: an updated systematic review and meta-analysis. Neonatology. 2008;94(3):176-182. doi:10.1159/000143397
Welsford M, Nishiyama C, Shortt C, et al. Room air for initiating term newborn resuscitation: a systematic review with meta-analysis. Pediatrics. 2019;143(1):e20181825. doi:10.1542/peds.2018-1825
Wyckoff Myra H, Wyllie J, Aziz K, et al. Neonatal life support: 2020 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Circulation. 2020;142(16):S185-S221. doi:10.1161/CIR.0000000000000895
Welsford M, Nishiyama C, Shortt C, et al. Initial oxygen use for preterm newborn resuscitation: a systematic review with meta-analysis. Pediatrics. 2019;143(1):e20181828. doi:10.1542/peds.2018-1828
Kapadia VS, Chalak LF, Sparks JE, Allen JR, Savani RC, Wyckoff MH. Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics. 2013;132(6):e1488-e1496. doi:10.1542/peds.2013-0978
Oei JL, Saugstad OD, Lui K, et al. Targeted oxygen in the resuscitation of preterm infants, a randomized clinical trial. Pediatrics. 2017;139(1):e20161452. doi:10.1542/peds.2016-1452
Dekker J, Martherus T, Lopriore E, et al. The effect of initial high vs. low FiO2 on breathing effort in preterm infants at birth: a randomized controlled trial. Front Pediatr. 2019;7:504. doi:10.3389/fped.2019.00504
Tataranno M, Oei J, Perrone S, et al. Resuscitating preterm infants with 100% oxygen is associated with higher oxidative stress than room air. Acta Paediatr. 2015;104(8):759-765. doi:10.1111/apa.13039
Bhola K, Lui K, Oei JL. Use of oxygen for delivery room neonatal resuscitation in non-tertiary Australian and New Zealand hospitals: a survey of current practices, opinions and equipment. J Paediatr Child Health. 2012;48(9):828-832. doi:10.1111/j.1440-1754.2012.02545.x
Sotiropoulos JX, Kapadia V, Vento M, et al. Oxygen for the delivery room respiratory support of moderate to late preterm infants. An international survey of clinical practice from 21 countries. Acta Paediatr. 2021;110(12):3261-3268. doi:10.1111/apa.16091
Seidler AL, Hunter KE, Cheyne S, Ghersi D, Berlin JA, Askie L. A guide to prospective meta-analysis. BMJ. 2019;367:l5342. doi:10.1136/bmj.l5342
Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365. doi:10.1136/bmj.c365
Seidler AL, Hunter KE, Espinoza D, Mihrshahi S, Askie LM. Quantifying the advantages of conducting a prospective meta-analysis (PMA): a case study of early childhood obesity prevention. Trials. 2021;22(1):78. doi:10.1186/s13063-020-04984-x
Askie L, Offringa M. Systematic reviews and meta-analysis. Semin Fetal Neonatal Med. 2015;20(6):403-409. doi:10.1016/j.siny.2015.10.002
Oei JL. Targeted oxygenation in the respiratory care of premature infants at delivery: effects on outcome (TORPIDO 30/60). Australian New Zealand clinical trials registry. Updated 17 Feburary 2020. Accessed March 16, 2021. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367049&isReview=true
Schmolzer G 30% or 60% oxygen at birth to improve neurodevelopmental outcomes in very low birthweight infants (HiLo). Accessed October 5, 2021. https://clinicaltrials.gov/ct2/show/NCT03825835
Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1. doi:10.1186/2046-4053-4-1
Stewart LA, Clarke M, Rovers M, et al. Preferred reporting items for a systematic review and meta-analysis of individual participant data. JAMA. 2015;313(16):1657. doi:10.1001/jama.2015.3656
Webbe JWH, Duffy JMN, Afonso E, et al. Core outcomes in neonatology: development of a core outcome set for neonatal research. Arch Dis Child Fetal Neonatal Ed. 2020;105(4):425-431. doi:10.1136/archdischild-2019-317501
Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: A study of infants with birth weights less than 1,500 gm. J Pediatr. 1978;92(4):529-534. doi:10.1016/s0022-3476(78)80282-0
Bayley N. Bayley Scales of Infant and Toddler Development, Third Edition: Administration Manual. Harcourt; 2006.
Bayley NA, Aylward GP. Bayley Scales of Infant and Toddler Development. 4th ed. Pearson Clinical; 2019.
Squires J, Bricker D. Ages & Stages Questionnaires®, Third Edition (ASQ®-3): a Parent-Completed Child Monitoring System. Paul H. Brookes Publishing Co., Inc.; 2009.
Hunter KE, Webster AC, Page MJ, et al. Searching clinical trials registers: guide for systematic reviewers. BMJ. 2022;377:e068791. doi:10.1136/bmj-2021-068791
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71
Griffin JW. metapoweR: an R package for comput meta-analytic statistical power. https://CRAN.R-project.org/package=metapower
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, eds Cochrane handbook for systematic reviews of interventions version 6.2 (updated February 2021). Cochrane. Accessed 5 October, 2022. www.training.cochrane.org/handbook
Higgins JPT, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928. doi:10.1136/bmj.d5928
Riley RD, Tierney JF, Stewart LA. Individual Participant Data Meta-Analysis: A Handbook for Healthcare Research. John Wiley & Sons; 2021.
Debray TPA, Moons KGM, Valkenhoef G, et al. Get real in individual participant data (IPD) meta-analysis: a review of the methodology. Res Synth Methods. 2015;6(4):293-309. doi:10.1002/jrsm.1160
Sterne JAC, White IR, Carlin JB, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. doi:10.1136/bmj.b2393
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162. doi:10.1186/s12874-017-0442-1
Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557-560. doi:10.1136/bmj.327.7414.557
Von Hippel PT. The heterogeneity statistic I2 can be biased in small meta-analyses. BMC Med Res Methodol. 2015;15(1):35. doi:10.1186/s12874-015-0024-z
Olkin I, Dahabreh IJ, Trikalinos TA. GOSH - a graphical display of study heterogeneity. Res Synth Methods. 2012;3(3):214-223. doi:10.1002/jrsm.1053
Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383-394. doi:10.1016/j.jclinepi.2010.04.026
Sotiropoulos JX, Oei JL, Schmölzer GM, et al. NETwork meta-analysis of trials of initial oxygen in preterm newborns (NETMOTION): a protocol for systematic review and individual participant data network meta-analysis of preterm infants <32 Weeks' gestation randomized to initial oxygen concentration for resuscitation. Neonatology. 2022;119:517-524. doi:10.1159/000525127
Chawanpaiboon S, Vogel JP, Moller A-B, et al. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019;7(1):e37-e46. doi:10.1016/s2214-109x(18)30451-0