Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation

Not Applicable

Completed

• Conditions: Neonates Needing Resuscitation at Birth
• Interventions: Procedure: Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection; Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection

• Registration Number: NCT04666233
• Lead Sponsor: University Hospital Padova

Brief Summary

There has been an increasing number of SARS-CoV-2 infections in pregnant women and neonates. Interventions including open airway suctioning, positive pressure ventilation, non-invasive respiratory support, tracheal intubation, and endotracheal drug administration are aerosol-generating medical procedures and may create a risk to the unprotected healthcare providers. The impact of using personal protective equipment during neonatal resuscitation maneuvers is unknown.

The objective of this study will be to compare the beginning of PPV and the duration of intubation between performing resuscitation with PPE for the prevention of SARS-Cov-2 infection and resuscitation without PPE for the prevention of SARS-Cov-2 infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-14
• Status Verified: 2021-03
• Study Start: 2021-03-16
• Primary Completion: 2021-03-23
• Study Completion: 2021-03-23
• Last Update Submitted: 2021-03-27
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Level III neonatal intensive care unit consultants, pediatric residents, and nurses. Participants will be divided into teams including a consultant and a nurse or a resident and a nurse during the simulation.

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Exclusion Criteria

• There are no exclusion criteria for this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Resuscitation with PPE for prevention of SARS-Cov-2 infection	Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection	-
Resuscitation without PPE for prevention of SARS-Cov-2 infection	Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection	-

Primary Outcome Measures

Name	Time	Method
Initiation of positive pressure ventilation	5 minutes

Secondary Outcome Measures

Name	Time	Method
Participant's opinion on discomfort using personal protective equipment	20 minutes	Level of discomfort in performing the procedures: 0 (no discomfort), 1 (low discomfort) ,2 (high discomfort)
Correct use of personal protective equipment	20 minutes
Duration of intubation procedure	5 minutes
Time of initiation of chest compressions	20 minutes

Trial Locations

Locations (2)

Daniele Trevisanuto; 🇮🇹 Padova, Italy

Central Teaching Hospital of Bolzano/Bozen; 🇮🇹 Bolzano, Italy