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

March 27, 2021 updated by: Daniele Trevisanuto, University Hospital Padova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bolzano, Italy
        • Central Teaching Hospital of Bolzano/Bozen
      • Padova, Italy, 35128
        • Daniele Trevisanuto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
Procedure: Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection
The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection
Active Comparator: Resuscitation without PPE for prevention of SARS-Cov-2 infection
Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection
The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Initiation of positive pressure ventilation
Time Frame: 5 minutes
5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Actual)

March 23, 2021

Study Completion (Actual)

March 23, 2021

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SARS-CoV-2-NEO-Res-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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