PEEP Resuscitation Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Newborn Resuscitation

Intervention / Treatment
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* Device: Upright Resuscitator with PEEP
* Device: Upright Resuscitator


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upright Resuscitator with PEEP<br>Ventilation with the Upright Resuscitator with PEEP | Device: Upright Resuscitator with PEEP<br> <br> |
| Active Comparator: Upright Resuscitator<br>Ventilation with the Upright Resuscitator (without PEEP) | Device: Upright Resuscitator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta heart rate (beats/minute) during each ventilation sequence |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |