Evidence map›Paper›PMID 19896902›Full record

Trial reportThe Lancet. Neurology2010

Assessment of brain tissue injury after moderate hypothermia in neonates with hypoxic-ischaemic encephalopathy: a nested substudy of a randomised controlled trial.

Mary Rutherford, Luca A Ramenghi, A David Edwards, Peter Brocklehurst, Henry Halliday, Malcolm Levene, Brenda Strohm, Marianne Thoresen, Andrew Whitelaw, Denis Azzopardi

4 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Neurology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 256 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
256citing papers in PubMed, 8 pooled it
46.0field-weighted citation impact, top 1% 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.

NCT00147030 nacompletednot on this map

Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy

TypeinterventionalSponsorImperial College LondonRan2002 to 2008Enrolled325ConditionsAsphyxia Neonatorum, Hypoxia, Encephalopathy, SeizuresArmsWhole body mild induced hypothermia
NCT01646619 phase3unknown statusnot on this mapstarted 2012, after this paper: background citation

A Multicenter Randomized Controlled Trial of Therapeutic Hypothermia Plus Magnesium Sulphate (MgSO4) Versus Therapeutic Hypothermia Plus Placebo in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy

TypeinterventionalSponsorSajjad RahmanRan2012 to 2014Enrolled300ConditionsSevere Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic EncephalopathyArmsMagnesium Sulphate, Placebo
NCT06730490 completednot on this mapstarted 2016, after this paper: background citation

Autonomic Nervous System Function in Hypoxic-Ischemic Infants Treated With Therapeutic Hypothermia

TypeobservationalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2016 to 2017Enrolled63ConditionsHypoxic-Ischemic Encephalopathy
NCT07292220 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Investigation of Neurofilament Light Chain (NfL) Levels in Newborns Diagnosed With Hypoxic Ischemic Encephalopathy: A Case-Control Study

Typeobservational_patient_registrySponsorMustafa GürkanRan2025 to 2026Enrolled20ConditionsHypoxic-Ischemic Encephalopathy
3 · Its place in the literature

Who cites it

256 citing papers in PubMed, 8 syntheses or guidelines pooled it, 596 citations in OpenAlex.

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196 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 2 countries.

Mary RutherfordPerinatal Imaging, MRC Clinical Sciences Centre, Hammersmith Hospital, London, UK.
Luca A Ramenghi
A David Edwards
Peter Brocklehurst
Henry Halliday
Malcolm Levene
Brenda Strohm
Marianne Thoresen
Andrew Whitelaw
Denis Azzopardi
Hammersmith Hospital · GBUniversity of Oxford · GBFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITQueen's University Belfast · GBSt Michael's Hospital · GBUniversity of Bristol · GBUniversity of Leeds · GB

Funding

Department of HealthMedical Research Council G0100126Medical Research Council G0200270Medical Research Council MC_U120081323Medical Research Council MC_U120088465
6 · The paper itself

Abstract

backgroundModerate hypothermia in neonates with hypoxic-ischaemic encephalopathy might improve survival and neurological outcomes at up to 18 months of age, although complete neurological assessment at this age is difficult. To ascertain more precisely the effect of therapeutic hypothermia on neonatal cerebral injury, we assessed cerebral lesions on MRI scans of infants who participated in the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) trial.

methodsIn the TOBY trial hypoxic-ischaemic encephalopathy was graded clinically according to the changes seen on amplitude integrated EEG, and infants were randomly assigned to intensive care with or without cooling by central telephone randomisation. The relation between allocation to hypothermia or normothermia and cerebral lesions was assessed by logistic regression with perinatal factors as covariates, and adjusted odds ratios (ORs) were calculated. The TOBY trial is registered, number ISRCTN 89547571.

findings325 infants were recruited in the TOBY trial between 2002 and 2006. Images were available for analysis from 131 infants. Therapeutic hypothermia was associated with a reduction in lesions in the basal ganglia or thalamus (OR 0.36, 95% CI 0.15-0.84; p=0.02), white matter (0.30, 0.12-0.77; p=0.01), and abnormal posterior limb of the internal capsule (0.38, 0.17-0.85; p=0.02). Compared with non-cooled infants, cooled infants had fewer scans that were predictive of later neuromotor abnormalities (0.41, 0.18-0.91; p=0.03) and were more likely to have normal scans (2.81, 1.13-6.93; p=0.03). The accuracy of prediction by MRI of death or disability to 18 months of age was 0.84 (0.74-0.94) in the cooled group and 0.81 (0.71-0.91) in the non-cooled group.

interpretationTherapeutic hypothermia decreases brain tissue injury in infants with hypoxic-ischaemic encephalopathy. The predictive value of MRI for subsequent neurological impairment is not affected by therapeutic hypothermia.

fundingUK Medical Research Council; UK Department of Health.

Indexed as

Hypothermia, InducedAge FactorsBrainElectroencephalographyFemaleHumansHypoxia-Ischemia, BrainInfant, NewbornLogistic ModelsMagnetic Resonance ImagingMaleNeuromuscular DiseasesOdds RatioPrognosisSensitivity and SpecificitySeverity of Illness Index

Identifiers

PMID19896902
PMCPMC2795146
OpenAlexW1988501897

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.