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Comparison of Two Different Resuscitation Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03587987
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Information provided by (Responsible Party):
Dr. Gene Dempsey, University College Cork

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.

Condition or disease Intervention/treatment Phase
Manual Ventilation Device: Neopff Device: rPap Not Applicable

Detailed Description:

Comparison of two different neonatal resuscitation devices (Neopuff and rPAP) in the Neonatal Unit in Cork University Maternity Hospital. Participants will use the devices on a mannequin. Performance of the two devices is judged by comparing the tidal volumes produced.

Participants will be recruited from the medical staff (Non-consultant Hospital Doctors and Consultants) of the neonatal unit.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manikin Study of the Comparison of Two Different Resuscitation Devices (Neopuff and rPAP) During Simulated Resuscitation in the Neonatal Unit
Estimated Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : August 30, 2018

Arm Intervention/treatment
Active Comparator: Neopuff
Device: Neopff
manual ventilation

Experimental: r PAP
rPap device
Device: rPap
Manual ventilation

Primary Outcome Measures :
  1. Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins [ Time Frame: 1 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Neonatology consultants and NCHD's from CUMH
  2. Participants must have completed Neonatal Resuscitation Programme (NRP)
  3. Participants must be working as doctors in the area of neonatology

Exclusion Criteria:

  1. Any history of cardiac or respiratory disorder
  2. Physicians who are post-call

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03587987

Contact: Eugene M Dempsey 0214920525

Sponsors and Collaborators
University College Cork

Responsible Party: Dr. Gene Dempsey, Principal Investigator, University College Cork Identifier: NCT03587987     History of Changes
Other Study ID Numbers: ECM 4 (x) 05/06/18
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No