Evidence map›Paper›PMID 39939099›Full record

ArticleBMJ paediatrics open2025

Targeted oxygenation in the respiratory care of premature infants at delivery-effects on outcome: a randomised controlled trial (Torpido 3060) study protocol.

Ju Lee Oei, Javeed Travadi, Adrienne Kirby, Ian Marschner, Carbo Yeung, Melinda Cruz, Ian Wright, Wendy Hague, Peter Davis, Alpana Ghadge and 5 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ paediatrics open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

15 authors.

Ju Lee OeiNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia ju-lee.oei@sydney.edu.au.ORCID http://orcid.org/0000-0002-7799-3771
Javeed TravadiFaculty of Medical and Health Sciences, Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand.
Adrienne KirbyNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Ian MarschnerNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Carbo YeungNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Melinda CruzNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Ian WrightThe University of Queensland, Brisbane, Queensland, Australia.
Wendy HagueNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Peter DavisNeonatal Medicine The Royal Women's Hospital Parkville VIC 3052 Australia, Melbourne, Victoria, Australia.
Alpana GhadgeNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
John SimesNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Anthony KeechNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Kei LuiDepartment of Newborn Care, The Royal Hospital for Women, Randwick, New South Wales, Australia.
David OsbornDepartment of Neonatology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
William Tarnow MordiNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe safest oxygen levels needed for preterm infant respiratory support at birth are uncertain. We aimed to compare the outcomes of infants up to 28

methodsThis randomised controlled phase III trial was stratified by (1) site, (2) gestation and (3) multiplicity. Infants between 23+0 to 28+6 weeks gestation were randomised to initial respiratory support with FiO PRIMARY OUTCOME: Survival to 36 weeks gestation without documented brain injury. ASSESSMENTS: FiO STATISTICAL ANALYSIS PLAN: Assuming 32% of infants would die or survive with brain injury by 36 weeks, 735 infants per arm (1470 total) were needed to detect a risk difference of 8% (25% relative risk reduction), with 10% non-adherence to protocol, 85% β and 5% α. ETHICS: Approved by the John Hunter Human Research Ethics Committee (2019/ETH/3837) for waiver of consent for all Australian sites for randomised allocation and primary outcome.

conclusionRecruitment started in 2018 and was achieved on 30 September 2024. The Data and Safety Committee review found no major safety concerns at 50% recruitment. TRIAL REGISTRATION NUMBER: ACTRN 12618000879268.

Indexed as

Infant, PrematureOxygenOxygen Inhalation TherapyRespiratory Distress Syndrome, NewbornClinical Trials, Phase III as TopicFemaleGestational AgeHumansInfant, NewbornMaleOxygen SaturationRandomized Controlled Trials as TopicOxygenChild HealthNeonatologyResuscitation

Identifiers

PMID39939099
PMCPMC11822438

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.