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NCT03587987

Comparison of Two Different Resuscitation Devices

Completed NA Last updated 28 February 2023
What this trial tests

NA trial testing Neopff in Manual Ventilation in 20 participants. Completed in 30 August 2018.

Timeline
3 July 2018
Primary endpoint
30 July 2018
30 August 2018

Quick facts

Lead sponsorUniversity College Cork
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment20
Start date3 July 2018
Primary completion30 July 2018
Estimated completion30 August 2018
Sites1 location across Ireland

Drugs / interventions tested

Conditions studied

Sponsor

University College Cork

Who can join

Adults 20 to 60, any sex, with Manual Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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