An interventional study of Training on Neonatal Resuscitation in Neonatal Complication and Neonatal Asphyxia, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Prevention
The goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin simulation.
The main questions it aims to answer are:
Maintaining airways and ensuring effective ventilation are the primary goals in the neonatal resuscitation algorithm.To achieve it, there are several devices, more or less invasive, such as a face mask, laryngeal Mask or tracheal tube.Among these, Laryngeal Mask can have significant advantages, including ease of use and speed of application even if used by inexperienced health personnel after a short training program.
The protocol involves the use of a neonatal manikin, which is already in the use at our simulation center. Ventilation of the manikin will be conducted using two possible masks: a face mask and a laryngeal mask. Before the simulations begin, each participant will receive a brief introduction on the technical characteristics of the manikin and how to use the two masks. A stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage. Consideration will also be given to whether corrective maneuvers will need to be performed during the use of each mask and the timing with which these maneuvers will be applied.
Finally, a pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's planned enrollment of 150 is below the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthcare Workers (physicians, nurses and midwives) of Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS
Other: Training on Neonatal Resuscitation
Improve training of health care personnel (physicians, nurses and midwives) on neonatal resuscitation through manikin simulation using two different devices: a face mask and a laryngeal mask. Before the simulations begin, each participant will receive a brief introduction on the technical characteristics of the manikin and how to use the two masks. A stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage. Consideration will also be given to whether corrective maneuvers will need to be performed during the use of each mask and the timing with which these maneuvers will be applied. Finally, a pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask.
Comparison of ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin training
. A stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage.
Time frame: During Training session
Comparison of differences in the time required to achieve optimal skills in using the two masks
. A stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage.
Time frame: During Training session
Evaluation of health care personnel's level of confidence in using laryngeal mask versus face mask
A pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask
Time frame: During Training session
Start is estimated for May 2025; primary completion for Jun 2025, 1 month later.
Of 33 non-industry interventional studies with no phase under Asphyxia Neonatorum, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 1 month is below that.
Counting every sponsor, half of 33 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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