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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: |
NCT03184948 |
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Date of registration:
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05/06/2017 |
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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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Understanding Neonatal Jaundice in Rwanda
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Scientific title:
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Understanding Neonatal Jaundice in Rwanda |
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Date of first enrolment:
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May 29, 2017 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03184948 |
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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: Crossover 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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Rwanda
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Contacts
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Name:
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Ketki Sheth, 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 California, Merced |
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Name:
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Lisine Tuysenge, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rwanda Pediatric Association |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For patient level record (de-identified), diagnosed by the facility for having infant
jaundice
- The facilities are included based on selection by the Ministry of Health for receiving
additional phototherapy machines.
Exclusion Criteria:
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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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Jaundice, Neonatal
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Intervention(s)
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Device: Brilliance
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Primary Outcome(s)
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Length of treatment for infant jaundice
[Time Frame: Through study completion, an average of 9 months]
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Length of hospital duration for infant jaundice
[Time Frame: Through study completion, an average of 9 months]
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Secondary Outcome(s)
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Improved Treatment of Jaundice by Not Sharing Phototherapy
[Time Frame: Through study completion, an average of 9 months]
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Improved Treatment of Jaundice by Reducing Exchange Transfusions
[Time Frame: Through study completion, an average of 9 months]
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Improved Treatment of Jaundice
[Time Frame: Through study completion, an average of 9 months]
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Improved Treatment of Jaundice by Using Single Phototherapy Device
[Time Frame: Through study completion, an average of 9 months]
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Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion
[Time Frame: Through study completion, an average of 9 months]
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Improved Treatment of Jaundice by Receiving Phototherapy
[Time Frame: Through study completion, an average of 9 months]
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Improved Treatment of Jaundice By Not Being Referred Elsewhere
[Time Frame: Through study completion, an average of 9 months]
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Increased rate of reduction in bilirubin
[Time Frame: Through study completion, an average of 9 months]
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Secondary ID(s)
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FWA Assurance No: 00001973
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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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