Neonates Needing Resuscitation at BirthNCT04666233
Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation
A study testing Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection and Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection in people with Neonates Needing Resuscitation at Birth, run by University Hospital Padova at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonates Needing Resuscitation at Birth
- What is being tested?
- Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection and Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Mar 2021to 23 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Central Teaching Hospital of Bolzano/Bozen
Bolzano
Daniele Trevisanuto
Padova, 35128
About this study
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
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.
- Conditions
- Neonates Needing Resuscitation at Birth
- Being tested
- Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection, Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infectionProcedure or surgery
The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection
Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infectionProcedure or surgery
The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation with PPE for prevention of SARS-Cov-2 infection | Experimental | Not described Receives: 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 | Not described Receives: Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of positive pressure ventilation
Measured: 5 minutes
Secondary outcomes (4)
Duration of intubation procedure
Measured: 5 minutes
Correct use of personal protective equipment
Measured: 20 minutes
Participant's opinion on discomfort using personal protective equipment
Level of discomfort in performing the procedures: 0 (no discomfort), 1 (low discomfort) ,2 (high discomfort)
Measured: 20 minutes
Time of initiation of chest compressions
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start16 Mar 2021
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonates Needing Resuscitation at BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666233
- Sponsor's protocol ID
- SARS-CoV-2-NEO-Res-01
- Status last verified
- Mar 2021
- First submitted
- 11 Dec 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22132664Trevisanuto 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.
PubMed 32335559Aziz 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.
PubMed 33081528Cavallin 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.
PubMed 34489350
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666233
- Acronym / sponsor ID
- SARS-CoV-2-NEO-Res-01
- Conditions
- Neonates Needing Resuscitation at Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuscitation with PPE for prevention of SARS-Cov-2 infection | Experimental | 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 | Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infectionThe team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection | Procedure or surgery | Resuscitation with PPE for prevention of SARS-Cov-2 infection |
| Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infectionThe team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection | Procedure or surgery | Resuscitation without PPE for prevention of SARS-Cov-2 infection |
Primary outcome
Initiation of positive pressure ventilation
Time frame: 5 minutes
4 secondary outcomes
Duration of intubation procedure
Time frame: 5 minutes
Correct use of personal protective equipment
Time frame: 20 minutes
Participant's opinion on discomfort using personal protective equipment
Time frame: 20 minutes
Time of initiation of chest compressions
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Results publication: PubMed 22132664Watson 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.
- Results publication: PubMed 32335559Trevisanuto 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.
- Results publication: PubMed 33081528Aziz 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.
- Derived from this study: PubMed 34489350Cavallin 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection and Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection in people with Neonates Needing Resuscitation at Birth, run by University Hospital Padova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of positive pressure ventilation (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666233, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.