Evidence map›Paper›PMID 39026197›Full record

ArticleBMC pediatrics2024

Whole-body hypothermia in mild neonatal encephalopathy: protocol for a multicentre phase III randomised controlled trial.

Reema Garegrat, Paolo Montaldo, Constance Burgod, Stuti Pant, Munirah Mazlan, Balamurugan Palanisami, Ela Chakkarapani, Kerry Woolfall, Samantha Johnson, Patricia Ellen Grant and 15 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05889507 (Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT05889507 phase3recruitingnot on this map

Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy: A Multicentre Randomised Controlled Trial

TypeinterventionalSponsorImperial College LondonRan2024 to 2030Enrolled426ConditionsNeonatal Encephalopathy, Newborn AsphyxiaArmsWhole body hypothermia, Targeted normothermia, Supportive neonatal intensive care, Follow up assessment at 2 years of age
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Observational
  4. Review
  5. Review
  6. 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

25 authors.

Reema GaregratCentre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, Du Cane Road, London, W12 0HS, England. r.garegrat@imperial.ac.uk.
Paolo MontaldoCentre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, Du Cane Road, London, W12 0HS, England.
Constance BurgodCentre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, Du Cane Road, London, W12 0HS, England.
Stuti PantCentre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, Du Cane Road, London, W12 0HS, England.
Munirah MazlanCentre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, Du Cane Road, London, W12 0HS, England.
Balamurugan PalanisamiNeonatal Medicine, Liverpool Women's NHS Foundation Trust, Liverpool, UK.
Ela ChakkarapaniUniversity of Bristol and St Michaels Hospital NHS Trust, Bristol, UK.
Kerry WoolfallPublic Health, Policy and Systems, University of Liverpool, Liverpool, UK.
Samantha JohnsonDepartment of Population Health Sciences, University of Leicester, Leicester, UK.
Patricia Ellen GrantDepartments of Radiology and Pediatrics, Boston Children,s Hospital, Harvard Medical School, Boston, USA.
Sarah LandPEEPS HIE Charity, London, UK.
Mariam MahmoudParent representative, London, UK.
Tony BradySealed Envelope, London, USA.
Victoria CorneliusImperial Clinical Trials Unit, Imperial College London, London, UK.
Eleri AdamsNeonatal Medicine, John Radcliffe Hospital NHS Trust, London, UK.
Jon DorlingNeonatal Medicine, University Hospital Southampton NHS Trust, London, UK.
Narendra AladangadiNeonatal Medicine, Homerton Healthcare NHS Foundation Trust, London, UK.
Paul FlemingNeonatal Medicine, Homerton Healthcare NHS Foundation Trust, London, UK.
Ronit PresslerDepartment of Neurophysiology, Great Ormond Street Hospital, London, UK.
Andrew ShennanDepartment of Obstetrics, Kings College London, London, UK.
Stavros PetrouProfessor of Health Economics, University of Oxford, Oxford, UK.
Aung SoeOliver Fisher Neonatal Intensive Care Unit, Medway Maritime Hospital, Medway NHS Foundation Trust, Kent, UK.
Paul BassetStats Consultancy, London, UK.
Seetha ShankaranDepartment of Neonatal-Perinatal Medicine, Wayne State University, Detroit, MI, USA.
Sudhin ThayyilCentre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, Du Cane Road, London, W12 0HS, England.

Funding

Genetic Analysis and Manipulation Core (GAEC)P50HD105351 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI Hisashi Umemori · 2021 to 2026
$9.4M
National Institute for Health Research (NIHR) Health Technology Assessment Programme NIHR152188NICHD NIH HHS P50 HD105351
6 · The paper itself

Abstract

backgroundMild hypoxic ischemic encephalopathy is associated with sub optimal cognition and learning difficulties at school age. Although whole-body hypothermia reduces death and disability after moderate or severe encephalopathy in high-income countries, the safety and efficacy of hypothermia in mild encephalopathy is not known. The cooling in mild encephalopathy (COMET) trial will examine if whole-body hypothermia improves cognitive development of neonates with mild encephalopathy.

methodsThe COMET trial is a phase III multicentre open label two-arm randomised controlled trial with masked outcome assessments. A total of 426 neonates with mild encephalopathy will be recruited from 50 to 60 NHS hospitals over 2 ½ years following parental consent. The neonates will be randomised to 72 h of whole-body hypothermia (33.5 ± 0.5 C) or normothermia (37.0 ± 0.5 C) within six hours or age. Prior to the recruitment front line clinical staff will be trained and certified on expanded modified Sarnat staging for encephalopathy. The neurological assessment of all screened and recruited cases will be video recorded and centrally assessed for quality assurance. If recruitment occurs at a non-cooling centre, neonates in both arms will be transferred to a cooling centre for continued care, after randomisation. All neonates will have continuous amplitude integrated electroencephalography (aEEG) at least for the first 48 h to monitor for seizures. Predefined safety outcomes will be documented, and data collected to assess resource utilization of health care. A central team masked to trial group allocation will assess neurodevelopmental outcomes at 2 years of age. The primary outcome is mean difference in composite cognitive scores on Bayley scales of Infant and Toddler development 4th Edition. DISCUSSION: The COMET trial will establish the safety and efficacy of whole-body hypothermia for mild hypoxic ischaemic encephalopathy and inform national and international guidelines in high income countries. It will also provide an economic assessment of whole-body hypothermia therapy for mild encephalopathy in the NHS on cost-effectiveness grounds. TRIAL REGISTRATION NUMBER: NCT05889507 June 5, 2023.

Indexed as

Hypothermia, InducedHypoxia-Ischemia, BrainClinical Trials, Phase III as TopicHumansInfant, NewbornMulticenter Studies as TopicRandomized Controlled Trials as TopicHypothermiaMagnetic resonance spectroscopyMild encephalopathy

Identifiers

PMID39026197
PMCPMC11256637

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.