PEEP Resuscitation Trial (PEEPrest)

June 11, 2019 updated by: Helse Stavanger HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Manyara
      • Haydom, Manyara, Tanzania, 9041
        • Haydom Lutheran Hospital, Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Upright Resuscitator with PEEP
Ventilation with the Upright Resuscitator with PEEP
Device: Upright Resuscitator with PEEP
ACTIVE_COMPARATOR: Upright Resuscitator
Ventilation with the Upright Resuscitator (without PEEP)
Device: Upright Resuscitator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Neonatal outcome dead versus alive
Time Frame: Up to 24 hours
Up to 24 hours
Time to cessation of ventilation
Time Frame: Up to 1 hour
Up to 1 hour
Time to heart rate above 140 beats/minute
Time Frame: Up to 1 hour
Up to 1 hour
Mean ariway pressures given
Time Frame: Up to 1 hour
Up to 1 hour
Time to detection of exhaled CO2 above 1% and 4%
Time Frame: Up to 1 hour
Up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

Haydom Lutheran Hospital

Investigators

  • Principal Investigator: Hussein Kidanto, MD, PhD, Muhimibili National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 19, 2016

First Posted (ESTIMATE)

November 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Upright PEEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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