Evidence map›Paper›PMID 23842585›Full record

Trial reportPediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies2013

Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

Frank W Moler, Faye S Silverstein, Kathleen L Meert, Amy E Clark, Richard Holubkov, Brittan Browning, Beth S Slomine, James R Christensen, J Michael Dean

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing 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

27 citing papers in PubMed.

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  10. Pediatric Out-of-Hospital Cardiac Arrest Characteristics and Their Association With Survival and Neurobehavioral Outcome.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016
    Trial
  11. Trial
  12. Targeted Temperature Management After Pediatric Cardiac Arrest Due To Drowning: Outcomes and Complications.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016
    Trial
  13. Family Burden After Out-of-Hospital Cardiac Arrest in Children.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016
    Trial
  14. Trial
  15. Efficacy outcome selection in the therapeutic hypothermia after pediatric cardiac arrest trials.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2015
    Trial
  16. Observational
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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

9 authors.

Frank W Moler1Department of Pediatrics, University of Michigan, Ann Arbor, MI. 2Department of Pediatrics, Wayne State University, Detroit, MI. 3Department of Pediatrics, University of Utah, Salt Lake City, UT. 4Department of Neuropsychology, Kennedy Krieger Institute, Baltimore, MD. 5Department of Pediatric Rehabilitation Medicine, Kennedy Krieger Institute, Baltimore, MD.
Faye S Silverstein
Kathleen L Meert
Amy E Clark
Richard Holubkov
Brittan Browning
Beth S Slomine
James R Christensen
J Michael Dean

Funding

Data Coordinating Center for the Collaborative Pediatric Critical Care Research NetworkU01HD049934 · NICHD · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2005 to 2020
$35.2M
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
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
Collaborative Pediatric Critical Care Research NetworkU10HD050096 · NICHD · WAYNE STATE UNIVERSITY · PI MEERT, KATHLEEN L. · 2005 to 2014
$3.2M
Metoclopramide prevents PICU nosocomial infectionU10HD049983 · NICHD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI CARCILLO, JOSEPH A · 2005 to 2014
$3.1M
Collaborative Pediatric Critical Care Research NetworkUG1HD050096 · NICHD · WAYNE STATE UNIVERSITY · PI MEERT, KATHLEEN L. · 2015 to 2020
$1.6M
1st Tier Drugs+Theophylline in Pediatric Severe AsthmaU10HD049945 · NICHD · SEATTLE CHILDREN'S HOSPITAL · PI ZIMMERMAN, JERRY JOHN · 2005 to 2010
$1.6M
Collaborative Pediatric Critical Care Research Network - Clinical SiteRL1HD107773 · NICHD · CENTRAL MICHIGAN UNIVERSITY · PI KATHLEEN L. MEERT · 2021 to 2026
$862k
Hypothermia for Pediatric Cardiac Arrest Planning GrantR21HD044955 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MOLER, FRANK W · 2003 to 2004
$306k
Planning Hypothermia Trial for Pediatric Cardiac ArrestR34HD050531 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MOLER, FRANK W · 2006 to 2006
$189k
NHLBI NIH HHS HL094339NHLBI NIH HHS HL094345NHLBI NIH HHS U01 HL094339NHLBI NIH HHS U01 HL094345NICHD NIH HHS HD044955NICHD NIH HHS HD050531NICHD NIH HHS R21 HD044955NICHD NIH HHS R34 HD050531NICHD NIH HHS RL1 HD107773NICHD NIH HHS U01 HD049934NICHD NIH HHS U01HD049934NICHD NIH HHS U10 HD049945NICHD NIH HHS U10HD049945NICHD NIH HHS U10 HD049981NICHD NIH HHS U10HD049981NICHD NIH HHS U10 HD049983NICHD NIH HHS U10HD049983,NICHD NIH HHS U10 HD050012NICHD NIH HHS U10HD050012NICHD NIH HHS U10 HD050096NICHD NIH HHS U10HD050096NICHD NIH HHS U10HD500009NICHD NIH HHS UG1 HD050096PHS HHS U03MC00001PHS HHS U03MC00003PHS HHS U03MC00006PHS HHS U03MC00007PHS HHS U03MC00008
6 · The paper itself

Abstract

objectiveTo describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials.

designMulticenter randomized controlled trials.

settingPediatric intensive care and cardiac ICUs in the United States and Canada. PATIENTS: Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent.

interventionsTherapeutic hypothermia or therapeutic normothermia. MEASUREMENTS AND MAIN

resultsFrom concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015.

conclusionsOver a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

Indexed as

Clinical ProtocolsIntensive Care Units, PediatricResearch DesignAdolescentCanadaChildChild, PreschoolFemaleHeart ArrestHumansHypothermia, InducedInfantInfant, NewbornIntensive Care UnitsMaleUnited States

Identifiers

PMID23842585
PMCPMC3947631

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.