Evidence map›Paper›PMID 38576007›Full record

ArticleTrials2024

Does the use of higher versus lower oxygen concentration improve neurodevelopmental outcomes at 18-24 months in very low birthweight infants?

Georg M Schmölzer, Elizabeth V Asztalos, Marc Beltempo, Hector Boix, Eugene Dempsey, Walid El-Naggar, Neil N Finer, Jo-Anna Hudson, Amit Mukerji, Brenda H Y Law and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03825835 (Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
3.8field-weighted citation impact, top 6% 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.

NCT03825835 narecruitingnot on this map

Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial

TypeinterventionalSponsorUniversity of AlbertaRan2022 to 2029Enrolled1,200ConditionsPremature Infant, Respiratory Distress Syndrome in Premature Infant, Neurodevelopmental OutcomeArms30% oxygen group, 60% oxygen group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 14 institutions in 5 countries.

Georg M SchmölzerCentre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, 10240 Kingsway Avenue NW, Edmonton, AB, T5H 3V9, Canada. georg.schmoelzer@me.com.ORCID http://orcid.org/0000-0001-9798-2415
Elizabeth V AsztalosDepartment of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.
Marc BeltempoDepartement of Pediatrics, Montreal Children's HospitalMcGill University Health CenterMcGill University, Montreal, QC, Canada.
Hector BoixDivision of Neonatology, Dexeus Quironsalud University Hospital, Barcelona, Spain.
Eugene DempseyINFANT Research Centre, University College Cork, Cork, Ireland.
Walid El-NaggarDepartment of Paediatrics, Dalhousie University, Halifax, Canada.
Neil N FinerSchool of Medicine, University of California, San Diego, CA, USA.
Jo-Anna HudsonFaculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada.
Amit MukerjiDivision of Neonatology, Department of Pediatrics, McMaster University, Hamilton, ON, Canada.
Brenda H Y LawCentre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, 10240 Kingsway Avenue NW, Edmonton, AB, T5H 3V9, Canada.
Maryna YaskinaWomen and Children's Health Research Institute (WCHRI), University of Alberta, Edmonton, Canada.
Prakesh S ShahDepartment of Pediatrics, Mount Sinai Hospital and University of Toronto, Toronto, Canada.
Ayman ShetaDepartment of Pediatrics and Child Health, University of Manitoba, Winnipeg, MB, Canada.
Amuchou SoraishamDepartment of Pediatrics, Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.
William Tarnow-MordiTrials Centre, National Health and Medical Research Council Clinical, University of Sydney, Camperdown, Australia.
Max VentoDepartment of Pediatrics, La Fe University and Polytechnic Hospital, Valencia, Spain.
behalf of the HiLo trial collaborators
University of Alberta · CADalhousie University · CAHospital Universitari i Politècnic La Fe · ESHospital Universitario Dexeus · ESMcMaster University · CAMemorial University of Newfoundland · CAMontreal Children's Hospital · CAMount Sinai Hospital · CASunnybrook Health Science Centre · CAThe University of Sydney · AUUniversity College Cork · IEUniversity of Calgary · CAUniversity of California San Diego · USUniversity of Manitoba · CA

Funding

Canadian Institute for Health Research Project Grant scheme - 201909
6 · The paper itself

Abstract

backgroundImmediately after birth, the oxygen saturation is between 30 and 50%, which then increases to 85-95% within the first 10 min. Over the last 10 years, recommendations regarding the ideal level of the initial fraction of inspired oxygen (FiO

methodsAn international cluster, cross-over randomized trial of initial FiO DISCUSSION: The use of supplementary oxygen may be crucial but also potentially detrimental to preterm infants at birth. The HiLo trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants. Should 60% initial oxygen concertation increase survival free of major neurodevelopmental outcomes at 18-24 months corrected age, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice.

trial registrationThe trial was registered on January 31, 2019, at ClinicalTrials.gov with the Identifier: NCT03825835.

Indexed as

Infant, Very Low Birth WeightResuscitationGestational AgeHumansInfantInfant, Extremely PrematureInfant, NewbornOxygenPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicOxygenDelivery roomExtremely pretermInfantNeonatal intensive careNeonatal mortalityOxygen

Identifiers

PMID38576007
PMCPMC10996184
OpenAlexW4393932994

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.