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NCT03587987
Comparison of Two Different Resuscitation Devices
NA trial testing Neopff in Manual Ventilation in 20 participants. Completed in 30 August 2018.
30 July 2018
Quick facts
| Lead sponsor | University College Cork |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 3 July 2018 |
| Primary completion | 30 July 2018 |
| Estimated completion | 30 August 2018 |
| Sites | 1 location across Ireland |
Drugs / interventions tested
- Neopff
- rPap
Conditions studied
- Manual Ventilation — all drugs for Manual Ventilation →
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.
Verify or expand the search:
- PubMed search for NCT03587987
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Related trials
Other University College Cork trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03587987 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University College Cork
- Last refreshed: 28 February 2023
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