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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2021-03-23

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.

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Resuscitation

COMPLETED PHASE3

Detailed Description

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Conditions

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Neonates Needing Resuscitation at Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The statistician performing data analysis will be masked to treatment allocation.

Study Groups

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Resuscitation with PPE for prevention of SARS-Cov-2 infection

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Resuscitation without PPE for prevention of SARS-Cov-2 infection

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No