Evidence map›Paper›PMID 29872859›Full record

SynthesisJAMA2018

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration.

Lisa M Askie, Brian A Darlow, Neil Finer, Barbara Schmidt, Ben Stenson, William Tarnow-Mordi, Peter G Davis, Waldemar A Carlo, Peter Brocklehurst, Lucy C Davies and 20 more

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMeta-Analysis
In one paragraph

Synthesis in JAMA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 197 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
197citing papers in PubMed, 8 pooled it
33.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01124331 nacompletednot on this map

Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis

TypeinterventionalSponsorUniversity of SydneyRan2005 to 2014Enrolled4,965ConditionsInfant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, DiseasesArmsHigher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)
NCT05017727 completednot on this mapstarted 2021, after this paper: background citation

Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce Hypoxic Events? A Randomised Controlled Crossover Study in Ventilated Infants

TypeobservationalSponsorKing's College Hospital NHS TrustRan2021 to 2023Enrolled31ConditionsPre-Term, Respiratory DiseaseArmsClosed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)
NCT05508308 nacompletednot on this mapstarted 2022, after this paper: background citation

Automated Oxygen Control for Preterm Infants On Continuous Positive Airway Pressure (CPAP): Phase 1/2 Trial In Southwest Nigeria

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2022 to 2023Enrolled49ConditionsNeonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure, Prematurity, Oxygen ToxicityArmsOxyMate, Manual oxygen control
3 · Its place in the literature

Who cites it

197 citing papers in PubMed, 8 syntheses or guidelines pooled it, 415 citations in OpenAlex.

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137 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 18 institutions in 6 countries.

Lisa M AskieNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
Brian A DarlowDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
Neil FinerDepartment of Pediatrics, University of California, San Diego.
Barbara SchmidtDivision of Neonatology, University of Pennsylvania, Philadelphia.
Ben StensonDepartment of Neonatology, Royal Infirmary of Edinburgh, Edinburgh, Scotland.
William Tarnow-MordiNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
Peter G DavisNewborn Research, Royal Women's Hospital, Departments of Obstetrics and Gynaecology, and Paediatrics, University of Melbourne, Melbourne, Australia.
Waldemar A CarloDepartment of Pediatrics, University of Alabama, Birmingham.
Peter BrocklehurstBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, England.
Lucy C DaviesNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
Abhik DasStatistics and Epidemiology Unit, RTI International, Rockville, Maryland.
Wade RichDepartment of Pediatrics, University of California, San Diego.
Marie G GantzStatistics and Epidemiology Unit, RTI International, Research Triangle Park, North Carolina.
Robin S RobertsDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Robin K WhyteDepartment of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
Lorrie CostantiniDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Christian PoetsDepartment of Neonatology, Tuebingen University Hospital, Tuebingen, Germany.
Elizabeth AsztalosDepartment of Paediatrics, University of Toronto, Toronto, Ontario, Canada.
Malcolm BattinNewborn Services, Auckland City Hospital, Auckland, New Zealand.
Henry L HallidayRoyal Maternity Hospital, Belfast, Ireland.
Neil MarlowEGA Institute for Women's Health, University College London, London, England.
Win TinDepartment of Neonatal Medicine, James Cook University, Middlesbrough, England.
Andrew KingNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, England.
Edmund JuszczakNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, England.
Colin J MorleyUniversity of Cambridge, Department of Obstetrics and Gynaecology, Cambridge, England.
Lex W DoyleNewborn Research, Royal Women's Hospital, Departments of Obstetrics and Gynaecology, and Paediatrics, University of Melbourne, Melbourne, Australia.
Val GebskiNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
Kylie E HunterNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
Robert J SimesNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.
Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration
McMaster University · CANational Health and Medical Research Council · AUThe University of Sydney · AUMurdoch Children's Research Institute · AURTI International · USUniversity of California San Diego · USUniversity of Oxford · GBAuckland City Hospital · NZDalhousie University · CAEdinburgh Royal Infirmary · GBJames Cook University Hospital · GBNational Maternity Hospital · IEUniversity College London · GBUniversity of Alabama at Birmingham · USUniversity of Birmingham · GBUniversity of Cambridge · GBUniversity of Otago · NZUniversity of Toronto · CA

Funding

Neonatal Research Network Data Coordinating Center (DCC)U10HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2008 to 2017
$62.3M
YALE UNIVERSITY CLINICAL AND TRANSLATIONAL SCIENCE AWARD PROGRAMUL1RR024139 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$56.8M
WORKER PROTECTION AGAINST AIRBORNE INFLUENZA - A PILOT STUDYM01RR007122 · NCRR · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KOCH, KENNETH L · 1992 to 2010
$35.2M
XOLAIR IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH FOOD ALLERGYM01RR000070 · NCRR · STANFORD UNIVERSITY · PI PARSONNET, JULIE · 1985 to 2008
$32.4M
UNIVERSITY OF IOWA CTSA FOR PEDIATRIC RESEARCHUL1RR024979 · NCRR · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2007 to 2011
$31.8M
ZUNI KIDNEY PROJECT STUDY I--POPULATION BASED SURVEY OF RENAL DISEASEM01RR000997 · NCRR · UNIVERSITY OF NEW MEXICO · PI MERTZ, GREGORY JAMES · 1985 to 2010
$30.0M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
ZOSUQUIDAR TRIHYDROCHLORIDE DURING CONVENTIONAL INDUCTION AND POST-REMISSIONM01RR000750 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI STORNIOLO, ANNA · 1985 to 2008
$25.5M
ZIPRASIDONE IN TOURETTES SYNDROME, OBSESSIVE COMPULSIVE &PERVASIVE DEV. DISORDERM01RR000125 · NCRR · YALE UNIVERSITY · PI ALPERN, ROBERT J · 1985 to 2006
$24.1M
Zevalin Radioimmunotherapy Using a Modified TreatmentM01RR000032 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI RICH, ROBERT R. · 1985 to 2008
$23.6M
Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1UL1RR025744 · NCRR · STANFORD UNIVERSITY · PI GREENBERG, HARRY BERNARD · 2008 to 2011
$22.4M
XANTHINE OXIDASE PRODUCTS IN MODULATION OF ENDOTHELIAL DYSFUNCTIONM01RR000059 · NCRR · UNIVERSITY OF IOWA · PI FAKHRY, ALI · 1985 to 2007
$22.3M
CIHRMedical Research Council G0400415NCRR NIH HHS M01 RR000030NCRR NIH HHS M01 RR000032NCRR NIH HHS M01 RR000039NCRR NIH HHS M01 RR000044NCRR NIH HHS M01 RR000054NCRR NIH HHS M01 RR000059NCRR NIH HHS M01 RR000064NCRR NIH HHS M01 RR000070NCRR NIH HHS M01 RR000080NCRR NIH HHS M01 RR000125NCRR NIH HHS M01 RR000633NCRR NIH HHS M01 RR000750NCRR NIH HHS M01 RR000997NCRR NIH HHS M01 RR006022NCRR NIH HHS M01 RR007122NCRR NIH HHS M01 RR008084NCRR NIH HHS M01 RR016587NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1 RR024979NCRR NIH HHS UL1 RR025008NCRR NIH HHS UL1 RR025744NICHD NIH HHS R03 HD079867NICHD NIH HHS U10 HD021364NICHD NIH HHS U10 HD021373NICHD NIH HHS U10 HD021385NICHD NIH HHS U10 HD021397NICHD NIH HHS U10 HD027851NICHD NIH HHS U10 HD027853NICHD NIH HHS U10 HD027856NICHD NIH HHS U10 HD027871NICHD NIH HHS U10 HD027880NICHD NIH HHS U10 HD027904NICHD NIH HHS U10 HD034216NICHD NIH HHS U10 HD036790NICHD NIH HHS U10 HD040461NICHD NIH HHS U10 HD040492NICHD NIH HHS U10 HD040498NICHD NIH HHS U10 HD040521NICHD NIH HHS U10 HD040689NICHD NIH HHS U10 HD053089NICHD NIH HHS U10 HD053109NICHD NIH HHS U10 HD053119NICHD NIH HHS U10 HD053124
6 · The paper itself

Abstract

Importance: There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen. Objective: To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity. Design, Setting, and Participants: Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation. Exposures: Spo2 target range that was lower (85%-89%) vs higher (91%-95%). Main Outcomes and Measures: The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities. Results: A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003). Conclusions and Relevance: In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.

Indexed as

Infant, Extremely PrematureBlindnessCerebral PalsyDeafnessDevelopmental DisabilitiesEnterocolitis, NecrotizingFemaleHumansIncidenceInfantInfant MortalityInfant, NewbornInfant, Premature, DiseasesKaplan-Meier EstimateMaleOximetryOxygen

Identifiers

PMID29872859
PMCPMC6583054
OpenAlexW2805867498

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.