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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04666233

Enrollment

Registered

2020-12-14

Start date

2021-03-16

Completion date

2021-03-23

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates Needing Resuscitation at Birth

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.

Interventions

PROCEDURENeonatal 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

PROCEDURENeonatal 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Masking description

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

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Initiation of positive pressure ventilation	5 minutes

Secondary

Measure	Time frame	Description
Duration of intubation procedure	5 minutes	—
Correct use of personal protective equipment	20 minutes	—
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)
Time of initiation of chest compressions	20 minutes	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026