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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resuscitation with PPE for prevention of SARS-Cov-2 infection | Experimental |
| |
| Resuscitation without PPE for prevention of SARS-Cov-2 infection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection | Procedure | The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of positive pressure ventilation | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of intubation procedure | 5 minutes | |
| Correct use of personal protective equipment | 20 minutes | |
| Participant's opinion on discomfort using personal protective equipment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Teaching Hospital of Bolzano/Bozen | Bolzano | Italy | ||||
| Daniele Trevisanuto |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22132664 | Result | 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. | |
| 32335559 | Result |
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The statistician performing data analysis will be masked to treatment allocation.
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| Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection | Procedure | The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection |
|
Level of discomfort in performing the procedures: 0 (no discomfort), 1 (low discomfort) ,2 (high discomfort) |
| 20 minutes |
| Time of initiation of chest compressions | 20 minutes |
| Padova |
| 35128 |
| Italy |
| 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. |
| 33081528 | Result | 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. |
| 34489350 | Derived | 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. |