Published ahead of print on February 25, 2003, doi:10.1164/rccm.200210-1175OC Am. J. Respir. Crit. Care Med., Volume 167, Number 10, May 2003, 1334-1340 A more recent version of this article appeared on May 15, 2003
Submitted on October 17, 2002 The feasibility of conducting clinical trials in infants and children with acute respiratory failureAdrienne G Randolph1*,1 Anesthesia, Children's Hospital, Boston, MA, USA; Anesthesia and Pediatrics, Harvard Medical School, Boston, MA, USA, 2 Pediatrics, Children's Hospital of Michigan, Detroit, MI, USA, 3 Anesthesia, Children's Hospital, Boston, MA, USA, 4 Pediatrics, Children's Hospital Oakland, Oakland, CA, USA, 5 Pediatrics, Children's Medical Center of Dallas, Dallas, TX, USA, 6 Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI, USA, 7 Critical Care Medicine, The Hospital for Sick Children, Toronto, ON, Canada, 8 Pediatrics, Children's Hospital and Regional Medical Center, Seattle, WA, USA, 9 Critical Care Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA, 10 Clinical Research Center, Children's Hospital, Boston, MA, USA, 11 Pediatrics, Duke Children's Hospital, Durham, NC, USA * To whom correspondence should be addressed. E-mail: adrienne.randolph{at}tch.harvard.edu.
Designing robust clinical trials in critically ill, mechanically ventilated children requires an understanding of the epidemiology and course of pediatric respiratory failure. As part of a clinical trial, we screened all mechanically ventilated children in nine large pediatric intensive care units (ICUs) across North America for 6 consecutive months. Of 6,403 total ICU admissions, 1,096 (17.1%) required mechanical ventilator support for a minimum of 24 hours. Of these, 701 (64%) met one or more exclusion criteria for trial enrollment. Common reasons for exclusion were upper airway obstruction (13.5%) and cyanotic congenital heart disease (11.5%). Life support interventions were restricted for 9.7% of patients, and 5.5% were chronically ventilator dependent. In the patients eligible for respiratory failure studies, 62.4% had an acute primary diagnosis of pulmonary disease, 14.2% neurologic disease and 8.9% cardiac disease. Chronic underlying conditions were present in 43.2% of patients. The most common acute diagnosis was bronchiolitis in infants (43.6%) and pneumonia in children one year and older (24.5%). Mortality was rare (1.6%), and the median duration of ventilation was 7 days. The design of clinical trials in critically ill children is feasible but must account for the diverse population, infrequent mortality and short duration of mechanical ventilation. Key words: pediatric, respiratory failure, mechanical ventilation
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