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

Study Overview
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Brief Summary
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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.

Official Title
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Does Personal Protective Equipment for the Prevention of SARS-Cov-2 Infection Impact the Timing of Ventilation in Neonates Needing Resuscitation at Birth? A Crossover Randomized Controlled Trial

Conditions
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Neonates Needing Resuscitation at Birth

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: There are no exclusion criteria for this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resuscitation with PPE for prevention of SARS-Cov-2 infection<br> | Procedure: Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection<br>* The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection<br>|
| Active Comparator: Resuscitation without PPE for prevention of SARS-Cov-2 infection<br> | Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection<br>* The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of positive pressure ventilation |  | 5 minutes | 

Secondary Outcome Measures

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