Evidence map›Paper›PMID 42289845›Full record

ArticleActa paediatrica (Oslo, Norway : 1992)2026

Budesonide and Surfactant Therapy Versus Surfactant Alone on Incidence of Lung Disease in Preterm Infants (BEST Lung): Study Protocol for a Systematic Review and Individual Participant Data Meta-Analysis With Nested Prospective Meta-Analysis.

James X Sotiropoulos, Brett J Manley, Sol Libesman, Namasivayam Ambalavanan, Abhik Das, Christopher J D Mckinlay, Nalinikanta Panigrahy, Melinda Cruz, David Nguyen, Jonathan Williams and 3 more

Abstract read
In one paragraph

Article in Acta paediatrica (Oslo, Norway : 1992), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

James X SotiropoulosNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
Brett J ManleyDepartment of Obstetrics, Gynaecology and Newborn Health, The University of Melbourne, Melbourne, Victoria, Australia.
Sol LibesmanNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
Namasivayam AmbalavananDivision of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0003-0731-9092
Abhik DasSocial, Statistical and Environmental Sciences Unit, RTI International, Rockville, Maryland, USA.ORCID https://orcid.org/0000-0003-2722-0479
Christopher J D MckinlayDepartment of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.
Nalinikanta PanigrahyRainbow Children's Hospital, Hyderabad, Telangana, India.ORCID https://orcid.org/0000-0003-4316-0517
Melinda CruzNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
David NguyenNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.ORCID https://orcid.org/0009-0009-7045-8600
Jonathan WilliamsNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
Peter DavisDepartment of Obstetrics, Gynaecology and Newborn Health, The University of Melbourne, Melbourne, Victoria, Australia.
Kylie E HunterNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-2796-9220
Anna Lene SeidlerNHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-0027-1623

Funding

Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School AgeR01HL157256 · NHLBI · NORTHWESTERN UNIVERSITY · PI Namasivayam Ambalavanan, NELSON R CLAURE · 2022 to 2026
$7.7M
NICHD Neonatal Research Network Clinical Center UABUG1HD034216 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WALDEMAR A. CARLO FONT · 2016 to 2026
$3.3M
Let-7b in BPDR01HL156275 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Namasivayam Ambalavanan · 2023 to 2026
$2.2M
National Health and Medical Research Council GNT2016662National Health and Medical Research Council GNT2031240National Health and Medical Research Council GNT2040943NHLBI NIH HHS R01 HL156275NHLBI NIH HHS R01 HL157256NICHD NIH HHS UG1 HD034216NIH HHS R01HL156275NIH HHS R01HL157256NIH HHS UG1HD034216Thrasher Research Fund
6 · The paper itself

Abstract

introductionBronchopulmonary dysplasia (BPD) is a leading cause of morbidity and mortality in preterm infants. Combining surfactant with budesonide has been proposed to prevent BPD, but results from existing randomised controlled trials (RCTs) are conflicting. Individual participant data meta-analysis (IPD-MA) synthesises raw trial data, increasing precision, improving assessment of data quality and enabling subgroup analyses. This IPD-MA aims to examine the effect of surfactant plus budesonide versus surfactant alone.

methodsWe will systematically search medical databases and trial registers for RCTs enrolling preterm infants born at < 32 weeks' gestation randomised to intratracheal surfactant alone or surfactant plus budesonide. Studies with major quality concerns will be excluded. Risk of bias will be assessed using Cochrane's RoB 2 tool. Two-stage fixed-effects IPD-MA will be performed with co-primary outcomes of all-cause mortality at hospital discharge and BPD at 36 weeks' postmenstrual age. Subgroups will be examined using treatment-covariate interactions. Certainty of evidence will be assessed using GRADE. A nested prospective meta-analysis will also be conducted. The study is preregistered on PROSPERO (CRD42023456941).

conclusionIf effective, surfactant plus corticosteroid would be a low-cost addition to standard care to reduce BPD and increase survival. IPD-MA will allow further insight into treatment effects.

Indexed as

Bronchopulmonary DysplasiaBudesonidePulmonary SurfactantsDrug Therapy, CombinationHumansIncidenceInfant, NewbornInfant, PrematureMeta-Analysis as TopicProspective StudiesRandomized Controlled Trials as TopicSystematic Reviews as TopicBudesonidePulmonary Surfactantsbronchopulmonary dysplasiabudesonideindividual participant data meta‐analysissteroidssurfactant

Identifiers

PMID42289845
PMCPMC13552583

What OpenQuestion holds

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Registered trials

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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.