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Comparison of Two Different Resuscitation Devices

U

University College Cork (UCC)

Status

Completed

Conditions

Manual Ventilation

Treatments

Device: rPap
Device: Neopff

Study type

Interventional

Funder types

Other

Identifiers

NCT03587987
ECM 4 (x) 05/06/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Neopuff
Active Comparator group
Description:
neopuff
Treatment:
Device: Neopff
r PAP
Experimental group
Description:
rPap device
Treatment:
Device: rPap

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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