Epidemiology, ventilation management, and clinical outcomes in children (PRoVENT-PED): first results from the 10-year, investigator-initiated, international, multicentre, prospective cohort study

Abstract

Background: Evidence supporting lung-protective ventilation in children overwhelmingly stems from adult trials. This study aimed to assess the epidemiology, ventilation management, and outcomes across predefined age groups of invasively ventilated critically ill children with or without paediatric acute respiratory distress syndrome (PARDS), and to identify potentially modifiable factors associated with outcome. Methods: This 10-year, investigator-initiated, international, multicentre, observational prospective cohort study was conducted in 83 ICUs across 34 countries worldwide. Paediatric intensive care units were invited to participate in a registry. This phase of the study enrolled children (younger than 18 years) admitted to a participating centre who received invasive ventilation for at least 12 h. Preterm infants of a postconceptional age younger than 40 weeks and those receiving extracorporeal membrane oxygenation were excluded from participation. All data collected, including patient demographics, baseline characteristics, and ventilation data, were part of standard clinical care and retrieved from medical records. The primary outcome was 28-day intensive care unit (ICU) mortality. This study is registered at ClinicalTrials.gov (NCT06220825), the first phase of the study is completed, subsequent phases on different topics are currently running. Findings: 1427 children (median age 24 months [IQR 7–96]; 799 [56%] were male and 628 [44%] were female) were enrolled between April 1, and June 30, 2024, and Oct 1, and Dec 31, 2024. PARDS was identified in 164 (11%) of 1427 children and occurred most frequently in preschool-aged children (aged 3 years to younger than 6 years). Ventilator management varied by age and PARDS status; decreased age and the presence of PARDS were associated with exposure to high airway pressures. 28-day ICU mortality was 14% (201 of 1427 children), and it was lowest in neonates (3 [3%] of 112 children) and higher in patients with PARDS than those without PARDS (44 [27%] of 164 vs 157 [12%] of 1263). Positive end-expiratory pressure (PEEP), driving pressure (ΔP) and fractional concentration of oxygen (FiO<inf>2</inf>) were identified as potentially modifiable factors independently associated with ICU mortality. Interpretation: Ventilation management in children varies substantially by age and PARDS status. Among potentially modifiable ventilation factors, only PEEP, ΔP, and FiO<inf>2</inf> were associated with 28-day mortality. Funding: Amsterdam University Medical Centre and University Medical Centre Groningen.