title: Exploring the safety and efficacy of targeted temperature management amongst infants with out-of-hospital cardiac arrest due to apparent life threatening events.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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).
authors.affiliation: Children's Hospital of Michigan, Wayne State University, 3901 Beaubien Boulevard, Detroit, MI 48201, USA. Electronic address: kmeert@med.wayne.edu.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Meert
authors.affiliation: University of Utah, 295 Chipeta Way, P. O. Box 581289, Salt Lake City, UT 84158, USA.
authors.forename: Russell
authors.initials: R
authors.lastname: Telford
authors.affiliation: University of Utah, 295 Chipeta Way, P. O. Box 581289, Salt Lake City, UT 84158, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Holubkov
authors.affiliation: Kennedy Krieger Institute, Johns Hopkins University, 707 North Broadway, Baltimore, MD 21205, USA.
authors.forename: Beth S
authors.initials: BS
authors.lastname: Slomine
authors.affiliation: Kennedy Krieger Institute, Johns Hopkins University, 707 North Broadway, Baltimore, MD 21205, USA.
authors.forename: James R
authors.initials: JR
authors.lastname: Christensen
authors.affiliation: University of Utah, 295 Chipeta Way, P. O. Box 581289, Salt Lake City, UT 84158, USA.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Dean
authors.affiliation: University of Michigan, CS Mott Children's Hospital, 1540 East Hospital Drive, Ann Arbor, MI 48109, USA.
authors.forename: Frank W
authors.initials: FW
authors.lastname: Moler
mesh_terms: D016887:Cardiopulmonary Resuscitation; D003128:Coma / Q000209:etiology / Q000628:therapy*; D005260:Female; D006336:Heart Massage; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D007223:Infant; D008297:Male; D058687:Out-of-Hospital Cardiac Arrest / Q000150:complications / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
keywords: Apparent life threatening event; Cardiac arrest; Functional outcome; Mortality; Sudden infant death syndrome; Therapeutic hypothermia