NCT02971553|CompletedDMC
PEEP Resuscitation Trial
PEEPrest
A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
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PEEPrest
A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
Sponsor study identifier
interventional
330
1 country
1
Study Start
October 2016
Actual (reported)Primary Completion
May 2018
Actual (reported)Study Completion
May 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2016
Actual (reported)November 17, 2016
Actual (reported)November 23, 2016
Actual (reported)May 2018
Actual (reported)May 2018
Actual (reported)Delta heart rate (beats/minute) during each ventilation sequence
10 minutes
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
Ventilation with the Upright Resuscitator with PEEP
Ventilation with the Upright Resuscitator (without PEEP)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Haydom Lutheran Hospital, Research Institute
Haydom, Manyara Region, 9041, Tanzania
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.
Hussein Kidanto, MD, PhD
Muhimibili National Hospital
330 participants (actual enrollment reported by the registry).
First Submitted
November 17, 2016
First Posted
November 23, 2016
Study Start
October 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 2018
Actual (reported)Study Completion
May 2018
Actual (reported)Last Updated
June 12, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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