Evidence map›Paper›PMID 30291883›Full record

Trial reportResuscitation2018

Therapeutic hypothermia after paediatric cardiac arrest: Pooled randomized controlled trials.

Barnaby R Scholefield, Faye S Silverstein, Russell Telford, Richard Holubkov, Beth S Slomine, Kathleen L Meert, James R Christensen, Vinay M Nadkarni, J Michael Dean, Frank W Moler

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Resuscitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. 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

10 authors.

Barnaby R ScholefieldBACR group, Institute of Inflammation and Ageing, University of Birmingham, UK. Electronic address: barney.scholefield1@nhs.net.
Faye S SilversteinUniversity of Michigan, Ann Arbor, MI, United States.
Russell TelfordUniversity of Utah, Salt Lake City, UT, United States.
Richard HolubkovUniversity of Utah, Salt Lake City, UT, United States.
Beth S SlomineKennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, United States.
Kathleen L MeertWayne State University, Detroit, MI, United States.
James R ChristensenKennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, United States.
Vinay M NadkarniChildren's Hospital of Philadelphia, Philadelphia, PA, United States.
J Michael DeanUniversity of Utah, Salt Lake City, UT, United States.
Frank W MolerUniversity of Michigan, Ann Arbor, MI, United States.

Funding

Michigan Institute for Clinical and Health Research (MICHR)UL1TR002240 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LUMENG, JULIE C, MASHOUR, GEORGE ALEXANDER · 2017 to 2022
$54.9M
MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
Michigan Institute for Clinical and Health Research (MCHR)UL1TR000433 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MASHOUR, GEORGE ALEXANDER · 2012 to 2016
$49.9M
Institutional Clinical and Translational Science AwardUL1TR000003 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2012 to 2015
$38.9M
Data Coordinating Center for the Collaborative Pediatric Critical Care Research NetworkU01HD049934 · NICHD · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2005 to 2020
$35.2M
NEUROIMAGING COREP30HD040677 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI MCCARTER, ROBERT JAMES · 2001 to 2015
$15.9M
THAPCA Trials - Scientific ApplicationU01HL094345 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MOLER, FRANK W · 2009 to 2016
$12.7M
THAPCA Trials - DCC ApplicationU01HL094339 · NHLBI · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2009 to 2015
$7.4M
Washington University Intellectual and Developmental Disabilities Research Center-Administrative Down Syndrome SupplementU54HD087011 · NICHD · WASHINGTON UNIVERSITY · PI CONSTANTINO, JOHN N. · 2015 to 2019
$7.1M
Washington University Intellectual and Developmental Disabilities Research CenterP30HD062171 · NICHD · WASHINGTON UNIVERSITY · PI CONSTANTINO, JOHN N. · 2010 to 2014
$4.3M
Physiologically Guided Ventilator Strategies in ChildrenU10HD050012 · NICHD · CHILDREN'S HOSPITAL OF LOS ANGELES · PI NEWTH, CHRISTOPHER JOHN · 2005 to 2014
$3.7M
Neurodevelopmental Outcome after Cardiac Intensive CareU10HD049981 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI WESSEL, DAVID LLOYD · 2005 to 2014
$3.7M
Department of Health CS-2015-15-016NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1 TR000433NCATS NIH HHS UL1 TR002240NCRR NIH HHS UL1 RR024986NHLBI NIH HHS U01 HL094339NHLBI NIH HHS U01 HL094345NICHD NIH HHS P30 HD040677NICHD NIH HHS P30 HD062171NICHD NIH HHS R21 HD044955NICHD NIH HHS R34 HD050531NICHD NIH HHS RL1 HD107773NICHD NIH HHS U01 HD049934NICHD NIH HHS U10 HD049945NICHD NIH HHS U10 HD049981NICHD NIH HHS U10 HD049983NICHD NIH HHS U10 HD050009NICHD NIH HHS U10 HD050012NICHD NIH HHS U10 HD050096NICHD NIH HHS U54 HD087011NICHD NIH HHS UG1 HD050096
6 · The paper itself

Abstract

backgroundSeparate trials to evaluate therapeutic hypothermia after paediatric cardiac arrest for out-of-hospital and in-hospital settings reported no statistically significant differences in survival with favourable neurobehavioral outcome or safety compared to therapeutic normothermia. However, larger sample sizes might detect smaller clinical effects. Our aim was to pool data from identically conducted trials to approximately double the sample size of the individual trials yielding greater statistical power to compare outcomes.

methodsCombine individual patient data from two clinical trials set in forty-one paediatric intensive care units in USA, Canada and UK. Children aged at least 48 h up to 18 years old, who remained comatose after resuscitation, were randomized within 6 h of return of circulation to hypothermia or normothermia (target 33.0 °C or 36.8 °C). The primary outcome, survival 12 months post-arrest with Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score at least 70 (scored from 20 to 160, higher scores reflecting better function, population mean = 100, SD = 15), was evaluated among patients with pre-arrest scores ≥70.

results624 patients were randomized. Among 517 with pre-arrest VABS-II scores ≥70, the primary outcome did not significantly differ between hypothermia and normothermia groups (28% [75/271] and 26% [63/246], respectively; relative risk, 1.08; 95% confidence interval [CI], 0.81 to 1.42; p = 0.61). Among 602 evaluable patients, the change in VABS-II score from baseline to 12 months did not differ significantly between groups (p = 0.20), nor did, proportion of cases with declines no more than 15 points or improvement from baseline [22% (hypothermia) and 21% (normothermia)]. One-year survival did not differ significantly between hypothermia and normothermia groups (44% [138/317] and 38% [113/ 297], respectively; relative risk, 1.15; 95% CI, 0.95 to 1.38; p = 0.15). Incidences of blood-product use, infection, and serious cardiac arrhythmia adverse events, and 28-day mortality, did not differ between groups.

conclusionsAnalysis of combined data from two paediatric cardiac arrest targeted temperature management trials including both in-hospital and out-of-hospital cases revealed that hypothermia, as compared with normothermia, did not confer a significant benefit in survival with favourable functional outcome at one year.

Indexed as

ChildChild, PreschoolComaFemaleHumansHypothermia, InducedInfantIntensive Care Units, PediatricKaplan-Meier EstimateMaleNeuropsychological TestsOutcome Assessment, Health CareOut-of-Hospital Cardiac ArrestPaediatric cardiac arrestRandomised controlled trialsTargeted temperature managementTherapeutic hypothermiaTherapeutic normothermia

Identifiers

PMID30291883
PMCPMC6361524

What OpenQuestion holds

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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.