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
Accepted on February 12, 2003
The feasibility of conducting clinical trials in infants and children with acute respiratory failure
Adrienne G Randolph1*, Kathleen L Meert2, Mary E O'Neil3, James H Hanson4, Peter M Luckett5, John H Arnold1, Rainer G Gedeit6, Peter N Cox7, Joan S Roberts8, Shekhar T Venkataraman9, Peter W Forbes10, and Ira M Cheifetz11
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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