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Randomized Controlled Trial
. 2016 Dec;109:40-48.
doi: 10.1016/j.resuscitation.2016.09.026. Epub 2016 Oct 11.

Exploring the Safety and Efficacy of Targeted Temperature Management Amongst Infants With Out-Of-Hospital Cardiac Arrest Due to Apparent Life Threatening Events

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Free PMC article
Randomized Controlled Trial

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 et al. Resuscitation. .
Free PMC article

Abstract

Objective: To 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.

Methods: Fifty-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.

Results: Amongst 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).

Conclusions: Mortality 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).

Keywords: Apparent life threatening event; Cardiac arrest; Functional outcome; Mortality; Sudden infant death syndrome; Therapeutic hypothermia.

Figures

Figure 1
Figure 1
Survival curve though 365 days for therapeutic hypothermia and therapeutic normothermia groups

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