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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: |
NCT03210194 |
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Date of registration:
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30/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized Cluster Trial on Innovative and Standard Strategies for Neonatal Resuscitation Training (RCPNEOPERU Project)
RCPNEOPERU |
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Scientific title:
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Continuous Training and Certification in Neonatal Resuscitation in Remote Areas Using a Multi-platform Information and Communication Technology Intervention Compared to Standard Training: A Randomized Cluster Trial |
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Date of first enrolment:
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April 1, 2017 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03210194 |
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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: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Peru
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Contacts
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Name:
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Carlos A Delgado, 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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Universidad Nacional Mayor de San Marcos, School of Medicine, Department of Pediatrics, NEO research group; Instituto Nacional de Salud del Niño, Neonatal Unit; Universidad Peruana Cayetano Heredia, CIDIS and MAMAWAWA research centers. Lima-Peru |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary and secondary level facilities located in Ayacucho and Cusco that have a
neonatal mortality rate higher than 15 per 1,000 livebirths will be eligible
Exclusion Criteria:
- Health facilities whose authorities refuse participation of their health
professionals, facilities with less than 290 births a year, facilities located at more
than 210 kilometres from the department capital and those located in high risk areas
due to social unrest will be excluded
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neonatal Asphyxia
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Intervention(s)
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Behavioral: Standard Neonatal Resuscitation Training
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Behavioral: MP-ICT Neonatal Resuscitation Training
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Primary Outcome(s)
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Heart rate at two minutes of life
[Time Frame: Up to six months]
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Secondary Outcome(s)
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Certified NRP providers
[Time Frame: Up to six months]
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Early neonatal mortality
[Time Frame: Up to six months]
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Oxygen requirement at 30 minutes
[Time Frame: Up to six months]
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Starting positive pressure ventilation
[Time Frame: Up to six months]
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Certified NRP instructors
[Time Frame: Up to six months]
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Apgar
[Time Frame: Up to six months]
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Early neonatal referral
[Time Frame: Up to six months]
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Heart rate >= 100 bpm
[Time Frame: Up to six months]
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Oxygen requirement at 10 minutes
[Time Frame: Up to six months]
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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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