The feasibility of conducting clinical trials in infants and children with acute respiratory failure.
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.
Randolph
Adrienne G
AG
Department of Anesthesia, Children's Hospital, Boston, MA 02115, USA. adrienne.randolph@tch.harvard.edu
Meert
Kathleen L
KL
O'Neil
Mary E
ME
Hanson
James H
JH
Luckett
Peter M
PM
Arnold
John H
JH
Gedeit
Rainer G
RG
Cox
Peter N
PN
Roberts
Joan S
JS
Venkataraman
Shekhar T
ST
Forbes
Peter W
PW
Cheifetz
Ira M
IM
D000208:Acute Disease; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D008297:Male; D015337:Multicenter Studies as Topic; D011336:Probability; D012016:Reference Values; D012121:Respiration, Artificial / Q000592:standards* / Q000639:trends; D012128:Respiratory Distress Syndrome / Q000175:diagnosis* / Q000628:therapy*; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis* / Q000628:therapy*; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome