PEEP Resuscitation Trial

Newborn Resuscitation Clinical Trial

— PEEPrest  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971553
• Other study ID #: Upright PEEP
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2019
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Newborn Resuscitation

Intervention

Device:
• Upright Resuscitator with PEEP

• Upright Resuscitator

Locations

Country	Name	City	State
Tanzania	Haydom Lutheran Hospital, Research Institute	Haydom	Manyara

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	Haydom Lutheran Hospital

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta heart rate (beats/minute) during each ventilation sequence		10 minutes
Secondary	Neonatal outcome dead versus alive		Up to 24 hours
Secondary	Time to cessation of ventilation		Up to 1 hour
Secondary	Time to heart rate above 140 beats/minute		Up to 1 hour
Secondary	Mean ariway pressures given		Up to 1 hour
Secondary	Time to detection of exhaled CO2 above 1% and 4%		Up to 1 hour