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Completed

NCT Number: NCT02971553

PEEP Resuscitation Trial

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.

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Key information

Conditions

Newborn Resuscitation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydom Lutheran Hospital, Research Institute

Haydom, Manyara Region, 9041, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upright Resuscitator with PEEP

Device

Upright Resuscitator

Device

Primary outcomes

  1. Delta heart rate (beats/minute) during each ventilation sequence

    Time frame: 10 minutes

Secondary outcomes

  1. Neonatal outcome dead versus alive

    Time frame: Up to 24 hours

  2. Time to cessation of ventilation

    Time frame: Up to 1 hour

  3. Time to heart rate above 140 beats/minute

    Time frame: Up to 1 hour

  4. Mean ariway pressures given

    Time frame: Up to 1 hour

  5. Time to detection of exhaled CO2 above 1% and 4%

    Time frame: Up to 1 hour

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Haydom Lutheran Hospital

Registry information

Official study title

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

Acronym: PEEPrest

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2016
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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