NCT02971553

PEEP Resuscitation Trial

A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Newborn Resuscitation

Interventions

Type	Name	Description
DEVICE	Upright Resuscitator with PEEP
DEVICE	Upright Resuscitator

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2016-11-23
• Last updated: 2019-06-12

Locations

1 site across 1 country: Tanzania