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Experimental Study and Training for Tanzanian Students and Health Professionals With a New Simulator for Manual Neonatal Ventilation

NCT07665164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-06-24

No results posted yet for this study

Summary

The goal of this clinical trial is to build capacity and assess the teaching effectiveness of a new simulator for manual neonatal ventilation in third-year nursing and clinical officer students, as well as healthcare professionals from the neonatology, gynecology, and pediatric departments.

The main questions it aims to answer are:

* Does the high-fidelity active setup of the simulator improve the percentage of target pressure achieved and the mean ventilation frequency compared to other configurations?
* How do different simulator configurations affect the training outcomes of unexperienced and experienced personnel, based on objective evaluations by expert clinicians and knowledge surveys?
* What is the self-reported usability and perceived usefulness of the different simulator configurations among the trainees? Researchers will compare a medium-fidelity passive setup, a high-fidelity passive setup with mechanical feedback, and a high-fidelity active setup with both mechanical and sensor feedback to see if the high-fidelity active configuration results in significantly higher clinical performance scores and better achievement of ventilation targets.

Participants will:

* Attend theoretical frontal lectures covering manual emergency ventilation procedures and medical simulation.
* Complete pre-training and post-training surveys to assess baseline knowledge, evaluate acquired skills, and report on the simulator's usability.
* Participate in hands-on simulator training, practicing the clinical procedure (positioning the newborn, positioning the mask, and ventilating) three times.
* Undergo a final simulation session for evaluation, where performance is objectively scored by a tutor and automatically recorded by the simulator's sensors.

Conditions

  • Teaching Manual Neonatal Ventilation

Interventions

OTHER

Training

Medical training on manual neonatal ventilation with phisical simulator

Sponsors & Collaborators

  • Doctors with Africa - CUAMM

    collaborator OTHER

  • Tosamaganga Regional Referral Hospital

    collaborator UNKNOWN

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2025-06-20
Completion
2025-06-20

Countries

  • Tanzania

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665164 on ClinicalTrials.gov