PEEP Resuscitation Trial

Not Applicable

Completed

• Conditions: Newborn Resuscitation
• Interventions: Device: Upright Resuscitator with PEEP; Device: Upright Resuscitator

• Registration Number: NCT02971553
• Lead Sponsor: Helse Stavanger HF

Brief 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-19
• Study First Posted: 2016-11-23
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.

Exclusion Criteria

• Babies with major deformities not deemed to be viable.
• Missing parental consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upright Resuscitator with PEEP	Upright Resuscitator with PEEP	Ventilation with the Upright Resuscitator with PEEP
Upright Resuscitator	Upright Resuscitator	Ventilation with the Upright Resuscitator (without PEEP)

Primary Outcome Measures

Name	Time	Method
Delta heart rate (beats/minute) during each ventilation sequence	10 minutes

Secondary Outcome Measures

Name	Time	Method
Neonatal outcome dead versus alive	Up to 24 hours
Time to cessation of ventilation	Up to 1 hour
Time to heart rate above 140 beats/minute	Up to 1 hour
Mean ariway pressures given	Up to 1 hour
Time to detection of exhaled CO2 above 1% and 4%	Up to 1 hour

Trial Locations

Locations (1)

Haydom Lutheran Hospital, Research Institute; 🇹🇿 Haydom, Manyara, Tanzania