PEEP Resuscitation Trial
PEEPrest
A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
1 other identifier
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJune 12, 2019
June 1, 2019
1.6 years
November 17, 2016
June 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Delta heart rate (beats/minute) during each ventilation sequence
10 minutes
Secondary Outcomes (5)
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
Study Arms (2)
Upright Resuscitator with PEEP
EXPERIMENTALVentilation with the Upright Resuscitator with PEEP
Upright Resuscitator
ACTIVE COMPARATORVentilation with the Upright Resuscitator (without PEEP)
Interventions
Eligibility Criteria
You may qualify if:
- Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.
You may not qualify if:
- Babies with major deformities not deemed to be viable.
- Missing parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- Haydom Lutheran Hospitalcollaborator
Study Sites (1)
Haydom Lutheran Hospital, Research Institute
Haydom, Manyara Region, 9041, Tanzania
Related Publications (1)
Holte K, Ersdal H, Eilevstjonn J, Gomo O, Klingenberg C, Thallinger M, Linde J, Stigum H, Yeconia A, Kidanto H, Stordal K. Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial. Pediatrics. 2020 Oct;146(4):e20200494. doi: 10.1542/peds.2020-0494. Epub 2020 Sep 11.
PMID: 32917847DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hussein Kidanto, MD, PhD
Muhimibili National Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 23, 2016
Study Start
October 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
June 12, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share