Comparison of Two Different Resuscitation Devices
Manikin Study of the Comparison of Two Different Resuscitation Devices (Neopuff and rPAP) During Simulated Resuscitation in the Neonatal Unit
1 other identifier
interventional
20
1 country
1
Brief Summary
There is a complex physiological process involved in establishing regular breaths at birth. After initiation of the first breath, fluid is removed from the alveoli and enough pressure must be generated to inflate the lungs . Most newborns will establish spontaneous regular breathing sufficient to maintain the heart rate above 100 beats/min and to improve perfusion within 3 minutes of birth. According to the neonatal resuscitation programme (NRP), if heart rate is below 100 or there is persistence of apnoea or gasping after the initial steps of drying/stimulation and oropharyngeal suction, intervention is required . The main focus of neonatal resuscitation is effective ventilation to improve gas exchange and prevent respiratory failure. After birth, approximately 4% to 10% of term and late preterm newborns will receive help breathing with positive-pressure ventilation (PPV). Adequate mask ventilation is essential when providing breaths during neonatal resuscitation. However, this can be difficult, especially for less experienced staff and may be affected by inadequate seal of the mask, gas leaks and airway obstruction. In addition, trauma may be caused by the volumes being given during pressure controlled ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2018
CompletedStudy Start
First participant enrolled
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedFebruary 28, 2023
February 1, 2023
27 days
July 3, 2018
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins
1 minutre
Study Arms (2)
Neopuff
ACTIVE COMPARATORneopuff
r PAP
EXPERIMENTALrPap device
Interventions
Eligibility Criteria
You may qualify if:
- Neonatology consultants and NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology
You may not qualify if:
- Any history of cardiac or respiratory disorder
- Physicians who are post-call
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCC
Cork, Ireland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 3, 2018
First Posted
July 16, 2018
Study Start
July 3, 2018
Primary Completion
July 30, 2018
Study Completion
August 30, 2018
Last Updated
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share