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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03133572 |
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Date of registration:
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26/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Neonatal Resuscitation With Supraglottic Airway Trial
NeoSupra |
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Scientific title:
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Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity |
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Date of first enrolment:
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May 8, 2018 |
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Target sample size:
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1163 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03133572 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Mozambique
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Uganda
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Contacts
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Name:
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Thorkild Tylleskär, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Bergen, Norway |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Inborn baby (=born in the hospital)
- Expected = 34-week gestation
- Expected birth weight = 2000 g
- Need for PPV at birth
- Parental consent
Exclusion Criteria:
- Major malformations (incompatible with sustained life or affecting the airways)
Age minimum:
N/A
Age maximum:
10 Minutes
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asphyxia Neonatorum
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Intervention(s)
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Device: Face-mask
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Device: Supraglottic airway
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Primary Outcome(s)
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Composite outcome of either a) early neonatal death or b) neonatal encephalopathy
[Time Frame: Day 7 of life]
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Secondary Outcome(s)
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Neonatal encephalopathy
[Time Frame: Day 7 of life]
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Advanced resuscitation
[Time Frame: Day 7 of life]
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Very early neonatal death
[Time Frame: Day 1 of life]
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Mild neonatal encephalopathy
[Time Frame: Day 7 of life]
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Number of adverse events (AEs) and serious adverse events (SAEs)
[Time Frame: Day 7 of life]
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Any hospital admission
[Time Frame: Day 7 of life]
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Early neonatal death
[Time Frame: Day 7 of life]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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