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

University Hospital Padova

Status: Completed

Conditions: Neonates Needing Resuscitation at Birth

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04666233

SARS-CoV-2-NEO-Res-01

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Volunteers: No 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 exclusion criteria for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

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

Experimental group

Treatment:

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

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

Active Comparator group

Treatment:

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