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NCT04666233

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

Completed NA Last updated 1 April 2021
What this trial tests

NA trial testing Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection in Neonates Needing Resuscitation at Birth in 48 participants. Completed in 23 March 2021.

Timeline
16 March 2021
Primary endpoint
23 March 2021
23 March 2021

Quick facts

Lead sponsorUniversity Hospital Padova
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment48
Start date16 March 2021
Primary completion23 March 2021
Estimated completion23 March 2021
Sites2 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Padova

Who can join

Eligibility, any sex, with Neonates Needing Resuscitation at Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Impact of personal protective equipment on neonatal resuscitation procedures: a randomised, cross-over, simulation study.
    Cavallin F, Lupi F, Bua B, Bellutti M, et al · · 2022 · cited 6× · PMID 34489350 · DOI 10.1136/archdischild-2021-322216

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