PEEP Resuscitation Trial (PEEPrest)

Helse Stavanger HF

Status: Completed

Conditions: Newborn Resuscitation

Treatments: Device: Upright Resuscitator with PEEP; Device: Upright Resuscitator

Study type: Interventional

Funder types: Other

Identifiers

NCT02971553

Upright PEEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

Upright Resuscitator with PEEP

Experimental group

Description:

Ventilation with the Upright Resuscitator with PEEP

Treatment:

Device: Upright Resuscitator with PEEP

Upright Resuscitator

Active Comparator group

Description:

Ventilation with the Upright Resuscitator (without PEEP)

Treatment:

Device: Upright Resuscitator