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

Abstract

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. 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. 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. 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. 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). 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. 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. ClinicalTrials.gov Identifier: NCT07665164.