Abstract
Acute respiratory failure (ARF) in children is a major cause of morbidity and Pediatric Intensive Care Unit (PICU) admission and often requires timely respiratory support to prevent deterioration. Traditionally, invasive mechanical ventilation has been the cornerstone of management, yet it carries risks such as ventilator-associated pneumonia, airway injury, and sedation-related complications. Non-invasive ventilation (NIV), including Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP), has emerged as a promising alternative that may reduce the need for intubation while maintaining adequate ventilation. However, evidence comparing the efficacy of NIV with intubation in pediatric ARF remains fragmented across diverse study designs and clinical contexts. This meta-analysis aimed to evaluate the comparative efficacy and safety of NIV versus invasive mechanical ventilation in pediatric patients with acute respiratory failure. Key clinical outcomes assessed included intubation rates, mortality, PICU length of stay, treatment failure, and ventilation-related complications. A comprehensive literature search was conducted across PubMed, Embase, Cochrane Library, Web of Science, and Google Scholar, supplemented by clinical trial registries and grey literature. Studies were included if they involved children under 18 years with ARF and compared NIV (CPAP/BiPAP) with intubation or standard therapy. Randomized controlled trials, prospective and retrospective cohorts, before-after studies, and meta-analyses were eligible. Data extraction and risk-of-bias assessments were performed independently by two reviewers using Cochrane Risk of Bias 2 tool (RoB 2) and Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tools. Meta-analysis was conducted using random-effects models, and outcomes were summarized as risk ratios or mean differences where appropriate. Fifteen studies involving over 10,000 pediatric patients met the inclusion criteria. Across randomized trials and observational cohorts, NIV significantly reduced the need for intubation, with pooled estimates demonstrating a 21% relative reduction in intubation risk (risk ratio or RR=0.79, 95% CI 0.63-1.00). Early NIV failure commonly occurred within 24 hours and was associated with severe hypoxemia, pneumonia, and apnea. Mortality rates were low across all groups and did not significantly differ between NIV and invasive ventilation. Successful NIV use was associated with fewer invasive procedures, reduced ventilator-associated complications, and a trend toward shorter PICU stays, although hospital length of stay findings were variable across studies. NIV was generally well tolerated, with minimal complications primarily related to mask interface issues. This meta-analysis demonstrates that NIV is an effective and safe first-line therapy for pediatric ARF, substantially reducing the need for intubation without increasing mortality or complications. Its success is strongly dependent on early initiation, careful patient selection, and close monitoring within experienced PICU settings. While NIV does not appear to change survival outcomes, it meaningfully decreases procedure-related risks and supports more efficient use of critical care resources. Standardized protocols and further large-scale randomized trials are needed to refine indications, optimize modality selection, and strengthen evidence regarding long-term outcomes.