Evidence map›Paper›PMID 39908019›Full record

Trial reportJAMA network open2025

Neurodevelopmental Outcomes After Nitric Oxide During Cardiopulmonary Bypass for Open Heart Surgery: A Randomized Clinical Trial.

Debbie A Long, Kristen S Gibbons, Stephen B Horton, Kerry Johnson, David H F Buckley, Simon Erickson, Marino Festa, Yves d'Udekem, Nelson Alphonso, Renate Le Marsney and 8 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA network open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Resuscitation in paediatric septic shock using vitamin C and hydrocortisone (RESPOND): The RESPOND randomised controlled trial statistical analysis plan.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2026
    Article
  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

18 authors.

Debbie A LongSchool of Nursing, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Australia.
Kristen S GibbonsChildren's Intensive Care Research Program, Child Health Research Centre, The University of Queensland, Brisbane, Australia.
Stephen B HortonCardiac Surgical Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.
Kerry JohnsonChildren's Intensive Care Research Program, Child Health Research Centre, The University of Queensland, Brisbane, Australia.
David H F BuckleyPaediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand.
Simon EricksonPaediatric Critical Care, Perth Children's Hospital, Western Australia and The University of Western Australia, Crawley, Australia.
Marino FestaKids Critical Care Research, Paediatric Intensive Care Unit, Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Yves d'UdekemFaculty of Medicine, Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
Nelson AlphonsoCardiac Surgery, Queensland Children's Hospital, Brisbane, Australia.
Renate Le MarsneyChildren's Intensive Care Research Program, Child Health Research Centre, The University of Queensland, Brisbane, Australia.
David S WinlawHeart Centre for Children, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Kate MastersonClinical Sciences Theme, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
Kim van LoonDepartment of Anaesthesiology, University Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, the Netherlands.
Paul J YoungIntensive Care Unit, Wellington Hospital, Wellington, New Zealand.
Andreas SchiblerJames Cook University, Townsville, Queensland, Australia.
Luregn J SchlapbachPaediatric Intensive Care Unit, Queensland Children's Hospital, Children's Health Queensland, Brisbane, Australia.
Warwick ButtFaculty of Medicine, Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
NITRIC Study Group and the Australian and New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Children with congenital heart defects who undergo cardiopulmonary bypass (CPB) surgery are at risk for delayed or impaired neurodevelopmental outcomes. Nitric oxide (NO) added to the CPB oxygenator may reduce systemic inflammation due to CPB and improve recovery from surgery, including improved neurodevelopmental outcomes. Objective: To investigate neurodevelopment, health-related quality of life (HRQOL), and factors associated with impaired neurodevelopment at 12 months post surgery in infants who received CPB with NO or standard CPB. Design, Setting, and Participants: This double-masked randomized clinical trial was conducted in 6 centers in Australia, New Zealand, and the Netherlands between July 19, 2017, and April 28, 2021, with a preplanned prospective follow-up 12 months postrandomization completed on August 5, 2022. The cohort included 1364 infants younger than 2 years who underwent open heart surgery with CPB for congenital heart disease. Interventions: The intervention group received NO 20 ppm into the CPB oxygenator. The control group received standard CPB. Main Outcomes and Measures: The primary outcome was neurodevelopment, defined as the Ages and Stages Questionnaire, Third Edition (ASQ-3) total score. Secondary outcomes were HRQOL and functional status as measured by Pediatric Quality of Life Inventory and modified Pediatric Overall Performance Category scores, respectively. Sensitivity analyses modeled the outcome for patients lost to follow-up. Results: Of 1318 infants alive 12 months after randomization, follow-up was performed in 927, with 462 patients in the NO group and 465 in the standard care group (median [IQR] age at follow-up, 16.6 [13.7-19.8] months; median [IQR] time since randomization, 12.7 [12.1-13.9] months; 516 male [55.7%]). There were no differences between the NO and standard care groups in ASQ-3 total score (mean [SD], 196.6 [75.4] vs 198.7 [73.8], respectively; adjusted mean difference, -2.24; 95% CI, -11.84 to 7.36). There were no differences in secondary outcomes. Prematurity (gestational age <37 weeks), univentricular lesions, congenital syndromes, and longer intensive care unit length of stay were associated with lower ASQ-3 total scores in adjusted multivariable analyses. Conclusions and Relevance: In this randomized clinical trial of infants with congenital heart disease, NO administered via the CPB oxygenator did not improve neurodevelopmental outcomes or HRQOL 12 months after open heart surgery. Further research should explore homogenous cohorts with higher surgical risk and higher-dose or alternative therapies. Trial Registration: ANZCTR Identifier: ACTRN12617000821392.

Indexed as

Cardiac Surgical ProceduresCardiopulmonary BypassHeart Defects, CongenitalNeurodevelopmental DisordersNitric OxideAustraliaDouble-Blind MethodFemaleHumansInfantInfant, NewbornMaleNetherlandsNew ZealandProspective StudiesQuality of LifeNitric Oxide

Identifiers

PMID39908019
PMCPMC11800016

What OpenQuestion holds

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LicenceCC BY
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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.