Clinical trial NCT04666233: Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonates Needing Resuscitation at Birth
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Initiation of positive pressure ventilation
timeFrame: 5 minutes
Secondary outcomes:
measure: Duration of intubation procedure
timeFrame: 5 minutes
measure: Correct use of personal protective equipment
timeFrame: 20 minutes
measure: Participant's opinion on discomfort using personal protective equipment
timeFrame: 20 minutes
measure: Time of initiation of chest compressions
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Central Teaching Hospital of Bolzano/Bozen
city: Padova
country: Italy
facility: Daniele Trevisanuto
Study officials:
References:
citation: Watson CM, Duval-Arnould JM, McCrory MC, Froz S, Connors C, Perl TM, Hunt EA. Simulated pediatric resuscitation use for personal protective equipment adherence measurement and training during the 2009 influenza (H1N1) pandemic. Jt Comm J Qual Patient Saf. 2011 Nov;37(11):515-23. doi: 10.1016/s1553-7250(11)37066-3.
citation: Trevisanuto D, Moschino L, Doglioni N, Roehr CC, Gervasi MT, Baraldi E. Neonatal Resuscitation Where the Mother Has a Suspected or Confirmed Novel Coronavirus (SARS-CoV-2) Infection: Suggestion for a Pragmatic Action Plan. Neonatology. 2020;117(2):133-140. doi: 10.1159/000507935. Epub 2020 Apr 24.
citation: Aziz K, Lee HC, Escobedo MB, Hoover AV, Kamath-Rayne BD, Kapadia VS, Magid DJ, Niermeyer S, Schmolzer GM, Szyld E, Weiner GM, Wyckoff MH, Yamada NK, Zaichkin J. Part 5: Neonatal Resuscitation: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S524-S550. doi: 10.1161/CIR.0000000000000902. Epub 2020 Oct 21. No abstract available.
citation: Cavallin F, Lupi F, Bua B, Bellutti M, Staffler A, Trevisanuto D. Impact of personal protective equipment on neonatal resuscitation procedures: a randomised, cross-over, simulation study. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):211-215. doi: 10.1136/archdischild-2021-322216. Epub 2021 Sep 6.