Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 2:02 PM
Study NCT ID:
NCT04666233
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2020-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The statistician performing data analysis will be masked to treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-27', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initiation of positive pressure ventilation', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'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', 'description': 'Level of discomfort in performing the procedures: 0 (no discomfort), 1 (low discomfort) ,2 (high discomfort)'}, {'measure': 'Time of initiation of chest compressions', 'timeFrame': '20 minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonates Needing Resuscitation at Birth']}, 'referencesModule': {'references': [{'pmid': '22132664', 'type': 'RESULT', '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.'}, {'pmid': '32335559', 'type': 'RESULT', '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.'}, {'pmid': '33081528', 'type': 'RESULT', '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.'}, {'pmid': '34489350', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT04666233', 'briefTitle': 'Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Padova'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SARS-CoV-2-NEO-Res-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resuscitation with PPE for prevention of SARS-Cov-2 infection', 'interventionNames': ['Procedure: Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resuscitation without PPE for prevention of SARS-Cov-2 infection', 'interventionNames': ['Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection']}], 'interventions': [{'name': 'Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection', 'type': 'PROCEDURE', 'description': 'The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection', 'armGroupLabels': ['Resuscitation with PPE for prevention of SARS-Cov-2 infection']}, {'name': 'Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection', 'type': 'PROCEDURE', 'description': 'The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection', 'armGroupLabels': ['Resuscitation without PPE for prevention of SARS-Cov-2 infection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bolzano', 'country': 'Italy', 'facility': 'Central Teaching Hospital of Bolzano/Bozen', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Daniele Trevisanuto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniele Trevisanuto', 'investigatorAffiliation': 'University Hospital Padova'}}}}