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Completed

NCT Number: NCT04666233

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

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.

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Key information

Conditions

Neonates Needing Resuscitation at Birth

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Teaching Hospital of Bolzano/Bozen, Bolzano, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection

Procedure

The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection

Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection

Procedure

The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection

Primary outcomes

  1. Initiation of positive pressure ventilation

    Time frame: 5 minutes

Secondary outcomes

  1. Duration of intubation procedure

    Time frame: 5 minutes

  2. Correct use of personal protective equipment

    Time frame: 20 minutes

  3. 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)

  4. Time of initiation of chest compressions

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.