Clinical trial design—effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome

Abstract

Purpose-This paper describes the methodology of an ongoing clinical trial of prone positioning in pediatric patients with acute lung injury (ALI). Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/ARDS without the risk of serious iatrogenic injury. It is not known if these improvements in oxygenation result in improvements in clinical outcomes. A clinical trial was needed to answer this question. Materials and Methods-The pediatric prone study is a multi-center, randomized, non-crossover, controlled clinical trial. The trial is designed to test the hypothesis that at the end of 28 days, children with ALI treated with prone positioning will have more ventilator free days than children treated with supine positioning. Secondary endpoints include the time to recovery of lung injury, organ failure free days, functional outcome, adverse events, and mortality from all causes. Pediatric patients, 42 weeks post-conceptual age to 18 years of age, are enrolled within 48 hours of meeting ALI criteria. Patients randomized to the prone group are positioned prone within 4 hours of randomization and remain prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days. Both groups are managed according to ventilator protocol, extubation readiness testing, and sedation protocols and hemodynamic, nutrition and skin care guidelines.

Effect of mechanical ventilation in the prone position on clinical outcomes in patients with acute hypoxemic respiratory failure: a systematic review and meta-analysis

“…Of these citations and additional citations retrieved from other sources, we retrieved 50 studies for detailed evaluation and excluded 29. We selected 13 primary randomized and quasi-randomized trials for inclusion in our review and meta-analysis, [22][23][24][25][26][27][28][29][30][31][32][33][34] along with 8 citations providing duplicate or supplementary data (data from 4 of 13 primary trials were distributed among several additional publications) [35][36][37][38][39][40][41][42] ( Figure 1). Reviewers had perfect agreement on study inclusion.…”

Pediatric acute lung injury

“…Many clinical case series have shown that prone position improves oxygenation in children [108][109][110][111][112][113][114][115][116][117][118]. Oxygenation improves within a short period (1-2 hours) after position change and can be sustained.…”

Respiratory Research in the Critically Ill Pediatric Patient: Why Is It So Difficult?

“…The primary reason for this eligibilityenrollment gap is parent or legal guardian refusal. 24 Parents are ethically entitled and legally empowered to make decisions on behalf of their children. 25 There is site-to-site variability in consent rates, based on PICU and investigatorspecific characteristics.…”