Faculty Collaboration Database

The feasibility of conducting clinical trials in infants and children with acute respiratory failure. Am J Respir Crit Care Med 2003 May 15;167(10):1334-40

Date

03/05/2003

Pubmed ID

12615617

DOI

10.1164/rccm.200210-1175OC

Scopus ID

2-s2.0-0038628989 (requires institutional sign-in at Scopus site)   152 Citations

Abstract

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.

Author List

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

Author

Rainer G. Gedeit MD Associate Chief Medical Officer in the Children's Administration department at Children's Wisconsin

MESH terms used to index this publication - Major topics in bold

Acute Disease
Adolescent
Child
Child, Preschool
Clinical Trials as Topic
Feasibility Studies
Female
Follow-Up Studies
Humans
Infant
Infant, Newborn
Intensive Care Units, Pediatric
Male
Multicenter Studies as Topic
Probability
Reference Values
Respiration, Artificial
Respiratory Distress Syndrome, Newborn
Risk Assessment
Severity of Illness Index
Treatment Outcome