An interventional study of Upright Resuscitator with PEEP and Upright Resuscitator in Newborn Resuscitation, sponsored by Helse Stavanger HF. Completed at 1 site in Tanzania. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Treatment
Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.
Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.
The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.
Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Ventilation with the Upright Resuscitator with PEEP
Device: Upright Resuscitator with PEEP
Ventilation with the Upright Resuscitator (without PEEP)
Device: Upright Resuscitator
Delta heart rate (beats/minute) during each ventilation sequence
Time frame: 10 minutes
Neonatal outcome dead versus alive
Time frame: Up to 24 hours
Time to cessation of ventilation
Time frame: Up to 1 hour
Time to heart rate above 140 beats/minute
Time frame: Up to 1 hour
Mean ariway pressures given
Time frame: Up to 1 hour
Time to detection of exhaled CO2 above 1% and 4%
Time frame: Up to 1 hour
Plan to share: No
Ran from Oct 2016 to primary completion in May 2018, 19 months.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF