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PEEP Resuscitation Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02971553
Acronym
PEEPrest
Enrollment
330
Registered
2016-11-23
Start date
2016-10-31
Completion date
2018-05-31
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Resuscitation

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.

Interventions

DEVICEUpright Resuscitator with PEEP
DEVICEUpright Resuscitator

Sponsors

Haydom Lutheran Hospital
CollaboratorOTHER
Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Delta heart rate (beats/minute) during each ventilation sequence10 minutes

Secondary

MeasureTime frame
Neonatal outcome dead versus aliveUp to 24 hours
Time to cessation of ventilationUp to 1 hour
Time to heart rate above 140 beats/minuteUp to 1 hour
Mean ariway pressures givenUp to 1 hour
Time to detection of exhaled CO2 above 1% and 4%Up to 1 hour

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026