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

Adrienne G. Randolph, Kathleen L. Meert, Mary E. O'Neil, James H. Hanson, Peter M. Luckett, John H. Arnold, Rainer G. Gedeit, Peter N. Cox, Joan S. Roberts, Shekhar T. Venkataraman, Peter W. Forbes, Ira M. Cheifetz

Research output: Contribution to journalArticlepeer-review

150 Scopus citations


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.

Original languageEnglish
Pages (from-to)1334-1340
Number of pages7
JournalAmerican Journal of Respiratory and Critical Care Medicine
Issue number10
StatePublished - May 15 2003


  • Mechanical ventilation
  • Pediatric
  • Respiratory failure


Dive into the research topics of 'The feasibility of conducting clinical trials in infants and children with acute respiratory failure'. Together they form a unique fingerprint.

Cite this