The feasibility of conducting clinical trials in infants and children with acute respiratory failure.


Journal Article

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 who were 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 the patients. The most common acute diagnosis was bronchiolitis in infants (43.6%) and pneumonia in children 1 year old 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.

Full Text

Duke Authors

Cited Authors

  • Randolph, AG; Meert, KL; O'Neil, ME; Hanson, JH; Luckett, PM; Arnold, JH; Gedeit, RG; Cox, PN; Roberts, JS; Venkataraman, ST; Forbes, PW; Cheifetz, IM; Pediatric Acute Lung Injury and Sepsis Investigators Network,

Published Date

  • May 15, 2003

Published In

Volume / Issue

  • 167 / 10

Start / End Page

  • 1334 - 1340

PubMed ID

  • 12615617

Pubmed Central ID

  • 12615617

International Standard Serial Number (ISSN)

  • 1073-449X

Digital Object Identifier (DOI)

  • 10.1164/rccm.200210-1175OC


  • eng

Conference Location

  • United States