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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: |
NCT02612727 |
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Date of registration:
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20/10/2015 |
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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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Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
FSPT |
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Scientific title:
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Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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174 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02612727 |
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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: 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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Nigeria
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Contacts
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Name:
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Tina M Slusher |
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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 Minnesota |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects will be eligible to participate in the study if all of the following
conditions exist:
1. At time of birth, infant is > 35 weeks gestation (or = 2.2 kg if gestational age
is not available.
2. Infant is < 14 days old at the time of enrollment.
3. Infant has an elevated TB defined as at the level recommended for high-risk
infants per AAP guidelines or higher.
4. Parent or guardian has given consent for the infant to participate.
Exclusion Criteria:
- Subjects will be excluded from enrollment in the study if any of the following
conditions exist:
1. Infants with a condition requiring referral for treatment not available at the
hospital study site.
2. Infants with a life-expectancy of < 24 hours at screening enrollment.
3. Infants requiring oxygen therapy unless that can be provided while under PT.
4. Infants clinically dehydrated or sunburned at the time of screening enrollment.
5. Infants with a temperature < 36.0 or > 37.5 degrees Centigrade that does not
return to normothermia within 1 hour.
Age minimum:
N/A
Age maximum:
14 Days
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: Filtered-sunlight phototherapy
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Device: Intensive phototherapy
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Primary Outcome(s)
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Efficacy of Phototherapy
[Time Frame: 2 to 10 days]
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Safety of Phototherapy
[Time Frame: 2 to 10 days]
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Secondary ID(s)
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1108M03601_Phase 2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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