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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03587987
Other study ID # ECM 4 (x) 05/06/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 3, 2018
Est. completion date August 30, 2018

Study information

Verified date February 2023
Source University College Cork
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Neopff
manual ventilation
rPap
Manual ventilation

Locations

Country Name City State
Ireland UCC Cork

Sponsors (1)

Lead Sponsor Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins 1 minutre
See also
  Status Clinical Trial Phase
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