Therapeutic hypothermia after pediatric cardiac arrest trials: the vanguard phase experience and implications for other trials.

ABSTRACT:

Objective

To determine whether an 18-month vanguard phase, in the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials, confirmed study feasibility and patient safety, a prerequisite to continued funding by the sponsor.

Design

Randomized controlled trial.

Setting

Pediatric intensive care and pediatric cardiac care units in 15 clinical sites in the United States and Canada.

Patients

Children aged 48 hrs to 18 yrs of age, with return of circulation after cardiac arrest.

Interventions

Therapeutic hypothermia vs. therapeutic normothermia.

Measurements and main results

The first 15 of 20 potential sites to obtain Institutional Review Board and subcontract approvals were selected as vanguard sites. Institutional Review Board approvals were obta

SUBMITTER: Pemberton VL 

PROVIDER: S-EPMC3540393 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature