Status:
WITHDRAWN
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
Lead Sponsor:
University of Minnesota
Conditions:
Jaundice
Jaundice, Neonatal
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief Summary
This is a descriptive prospective study of safety and efficacy of the reflective PT ring device. Neonates with an elevated total serum bilirubin (TSB) meeting PT criteria per their clinician during ho...
Detailed Description
Neonatal jaundice (NNJ) continues to be a significant global problem affecting over 80% of neonates while severe neonatal jaundice affects at least 481,000 neonates annually. Jaundice and jaundice rel...
Eligibility Criteria
Inclusion
- Males or female neonates greater than or equal to 35 weeks gestational age
- Elevated total serum bilirubin levels meeting PT criteria in the first 7 days of life
Exclusion
- Neonates, who are mechanically ventilated
- Neonates requiring continuous positive airway pressure
- Neonates with a history of apnea, bradycardia
- Patients with known cyanotic heart disease
- Patients experiencing temperature instability or desaturation episodes in 24hr prior to enrollment will be excluded.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04021927
Start Date
September 1 2019
End Date
January 1 2021
Last Update
February 23 2021
Active Locations (1)
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1
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States, 55404