Neonatal Ventilation Training Using a Low-Cost, High-Fidelity Simulator in a Low-Resource Setting: A Randomized Clinical Trial.

Importance: Neonatal mortality rates in sub-Saharan Africa remain high (26 per 1000 live births). Limited access to advanced respiratory support and shortage of trained health personnel make manual ventilation a lifesaving, yet high-risk, essential competence. Simulation-based training may strengthen neonatal ventilation skills, but evidence on acceptability and educational effectiveness of low-cost, high-fidelity simulators in resource-limited settings is limited. Objective: To build local capacity in manual neonatal ventilation and to assess acceptability and educational effectiveness of different simulator configurations across participants with varying levels of clinical experience. Design, Setting, and Participants: This randomized clinical trial was conducted from June 17 to 20, 2025, at a regional-level referral hospital in Tanzania. Participants included undergraduate medical students with no prior neonatal ventilation experience and local health professionals. Interventions: Participants were randomly assigned to 1 of 3 simulator configurations (medium-fidelity passive setup with no feedback, high-fidelity passive setup with mechanical feedback, and high-fidelity active setup with mechanical and sensors feedback). All participants received a 4-day training program consisting of theoretical lectures, hands-on simulation training with 1 of the 3 simulator configurations, and a standardized final evaluation. Main Outcomes and Measures: The primary outcome was objective ventilatory performance measured by the simulator during the hands-on sessions, defined as ventilation frequency and peak inspiratory pressure (PIP). Secondary outcomes included tutor-based performance evaluation, theoretical knowledge assessment in a 10-item questionnaire, and practical ventilation performance evaluation in a 12-item checklist. Tertiary outcomes were user-reported acceptability, perceived usefulness, perceived ease of use, behavioral intention, and simulator fidelity, assessed using the Technology Acceptance Model (TAM). Results: Both students (42 participants; median [IQR] age, 21 [20-22] years; 25 female [59.5%]) and health professionals (37 participants; median [IQR] age, 26 [23-29] years; 30 female [81.1%]) demonstrated improvements in theoretical knowledge (posttraining vs pretraining mean [SE] score [maximum 10 points]: students, 8.88 [0.13] vs 8.29 [0.17]; P < .001; health professionals, 9.14 [0.13] vs 8.65 [0.17]; P = .03) and practical ventilation performance following training (mean [SD] evaluation score [maximum 12 points]: students, 10.4 [0.7]; health professionals, 10.2 [0.9]). Training effectiveness varied by simulator configuration and participant experience. Among students, a medium-fidelity configuration was associated with improved ventilation frequency and PIP, whereas among health professionals, an active high-fidelity configuration supported improved performance during hands-on training. TAM scores confirmed a high simulator acceptability with no differences between groups. Conclusions and Relevance: In this randomized clinical trial of an adaptable, low-cost, high-fidelity neonatal ventilation simulator, effective training across heterogeneous learner groups in a resource-limited setting was supported; tailoring simulator feedback to learners' baseline experience enhanced training effectiveness. These findings support the feasibility of scalable, simulation-based neonatal ventilation training in low-resource environments. Further research on skill retention, transfer to clinical practice, and neonatal outcomes are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT07665164.