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Randomized Controlled Trial Multicenter Study
Exploring the safety and efficacy of targeted temperature management amongst infants with out-of-hospital cardiac arrest due to apparent life threatening events.
- Kathleen Meert, Russell Telford, Richard Holubkov, Beth S Slomine, James R Christensen, J Michael Dean, Frank W Moler, and Therapeutic Hypothermia after Paediatric Cardiac Arrest (THAPCA) Trial Investigators.
- Children's Hospital of Michigan, Wayne State University, 3901 Beaubien Boulevard, Detroit, MI 48201, USA. Electronic address: kmeert@med.wayne.edu.
- Resuscitation. 2016 Dec 1; 109: 404840-48.
ObjectiveTo explore the safety and efficacy of targeted temperature management amongst infants with out-of-hospital cardiac arrest due to an apparent life threatening event (ALTE) recruited to the Therapeutic Hypothermia after Paediatric Cardiac Arrest Out-of-Hospital trial.MethodsFifty-four infants (48h to <1year of age) with ALTE who received chest compressions for ≥2min, were comatose, and required mechanical ventilation after return of circulation were included. Infants were randomised to therapeutic hypothermia (33°C) (n=26) or therapeutic normothermia (36.8°C) (n=28) within six hours of return of circulation. Outcomes included 12-month survival with Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score ≥70, 12-month survival, change in VABS-II score from pre-arrest to 12 months post-arrest, and select safety measures.ResultsAmongst infants with pre-arrest VABS-II ≥70 (n=52), there was no difference in 12-month survival with VABS-II ≥70 between therapeutic hypothermia and therapeutic normothermia groups (2/25 (8.0%) vs. 1/27 (3.7%); relative risk 2.16; 95% confidence interval 0.21-22.38, p=0.60). Amongst all evaluable infants (n=53), the change in VABS-II score from pre-arrest to 12 months post-arrest did not differ (p=0.078) between therapeutic hypothermia and therapeutic normothermia groups, nor did 12-month survival (5/26 (19.2%) vs. 1/27 (3.7%); relative risk 5.19; 95% confidence interval 0.65-41.50, p=0.10).ConclusionsMortality was high amongst infants that were comatose after out-of-hospital cardiac arrest due to ALTE in both therapeutic hypothermia and therapeutic normothermia treated groups. Functional status was markedly reduced among survivors. (ClinicalTrials.gov, NCT00878644).Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
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