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

NCT07665164 | Completed

• 1 other identifier: NIMR/HQ/R.8a/Vol.IX/4983
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Manual neonatal ventilation training with phisical simulator; Medical training; Medical simulation; Neonatal ventilation; Manual ventilation

Outcome Measures

Primary Outcomes (2)

• Peak Inspiratory Pressure (PIP) (Objective 1)

  The primary outcome, used to assess the Objective 1, was the ventilatory performance measured by the simulator, i.e. Peak Inspiratory Pressure (PIP) during hands-on training on Day 2 and Day 3, and the evaluation session on Day 4. In accordance with international guidelines, we considered as gold-standard a PIP of 25 cmH₂O (centimeters of water). For each participant and trial, we computed the mean and standard deviation of PIP.

  Day 2, Day 3 and Day 4

• Ventilation Rate (Objective 1)

  The other primary outcome, used to assess the Objective 1, was the ventilatory performance measured by the simulator, i.e. Ventilation Rate during hands-on training on Day 2 and Day 3, and the evaluation session on Day 4. In accordance with international guidelines, we considered as gold-standard a Ventilation Rate of 40 breaths per minute. For each participant and trial, we computed the mean and standard deviation of the Ventilation Rate .

  Day 2, Day 3 and Day 4

Secondary Outcomes (1)

• Skill acquisition assessment (Objectives 2 and 3)

  Day 1 and day 4

Other Outcomes (1)

• User-reported usability and perceived usefulness (Objective 4)

  Day 4

Study Arms (3)

Training with simulator configuration A

EXPERIMENTAL

Group A used a medium-fidelity passive setup of the simulator without mechanical feedback or mobile user interface guidance.

Other: Training

Training with simulator configuration B

EXPERIMENTAL

Group B used a high-fidelity passive setup of the simulator providing mechanical feedback through chest and/or abdominal rise, without mobile user interface guidance.

Other: Training

Training with simulator configuration C

EXPERIMENTAL

Group C used a high-fidelity active setup of the simulator combining mechanical feedback with real-time sensor-based guidance via a mobile user interface.

Other: Training

Interventions

Training OTHER

Medical training on manual neonatal ventilation with phisical simulator

Training with simulator configuration A; Training with simulator configuration B; Training with simulator configuration C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Third-year nursing students enrolled at the Tosamaganga Institute of Health and Allied Sciences (TIHAS).
• Third-year clinical officer students enrolled at TIHAS.
• Healthcare professionals working at Tosamaganga Hospital within the neonatology, gynecology, midwifery, and pediatrics departments.
• Individuals who voluntarily choose to attend the course.

You may not qualify if:

• Healthcare professionals working in fields outside of nursing, gynecology, midwifery, neonatology, and pediatrics.
• Participants who fail to complete the full training program, either by not attending all sessions or by prematurely withdrawing from the course.

Sponsors & Collaborators

• Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna: lead
• Doctors with Africa - CUAMM: collaborator
• Tosamaganga Regional Referral Hospital: collaborator
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

Tosamaganga Regional Referral Hospital

Tosamaganga, Iringa, P.O. Box 11, Tanzania

Location

Related Publications (4)

• Maglio S, Tamirat S, Tesfaye M, Wolde M, Tognarelli S, Menciassi A, Facci E. Toward the design of a tailored training course for birth assistance: an Ethiopian experience. Pan Afr Med J. 2024 Jan 26;47:32. doi: 10.11604/pamj.2024.47.32.42221. eCollection 2024.

  PMID: 38586071 BACKGROUND

• Turatsinze S, Willson A, Sessions H, Cartledge PT. Medical student satisfaction and confidence in simulation-based learning in Rwanda - Pre and post-simulation survey research. Afr J Emerg Med. 2020 Jun;10(2):84-89. doi: 10.1016/j.afjem.2020.01.007. Epub 2020 Mar 9.

  PMID: 32612914 BACKGROUND

• Boling B, Hardin-Pierce M. The effect of high-fidelity simulation on knowledge and confidence in critical care training: An integrative review. Nurse Educ Pract. 2016 Jan;16(1):287-93. doi: 10.1016/j.nepr.2015.10.004. Epub 2015 Oct 23.

  PMID: 26520213 BACKGROUND

• Lee HC, Strand ML, Finan E, Illuzzi J, Kamath-Rayne BD, Kapadia V, Mahgoub M, Niermeyer S, Schexnayder SM, Schmolzer GM, Weglarz J, Williams AL, Weiner GM, Wyckoff M, Yamada NK, Szyld E. Part 5: Neonatal Resuscitation: 2025 American Heart Association and American Academy of Pediatrics Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2025 Oct 21;152(16_suppl_2):S385-S423. doi: 10.1161/CIR.0000000000001367. Epub 2025 Oct 22.

  PMID: 41122887 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 24, 2026
• Study Start: June 17, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting date: Janualy 1st 2026 End date: November 30st 2026
• Access Criteria: Data can be accessed by reseachers upon request only for reseach purpose and with a signed data access agreement after approval of a proposal. Any request can be sent to arianna.menciassi@santannapisa.it

Locations

TA (1)