Jaundice, Neonatal Clinical Trial
Official title:
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
Verified date | February 2021 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 hospital admission will be eligible for enrollment after informed parental consent.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Days |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin Healthcare Research Institute | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Reflective Ring PT Device: umber of participants who experience fluctuations of body temperature | Number of participants who experience fluctuations of body temperature outside the normal range during treatment | Entirety of hospital admission, approximately 5 days | |
Primary | Safety of Reflective Ring PT Device: Number of participants who experience apnea | Number of participants who experience apnea during treatment | Entirety of hospital admission, approximately 5 days | |
Primary | Safety of Reflective Ring PT Device: Number of participants who experience a bradycardic episode | Number of participants who experience a bradycardic episode during treatment | Entirety of hospital admission, approximately 5 days | |
Primary | Safety of Reflective Ring PT Device: Number of participants who experience an episode of oxygen desaturation | Number of participants who experience an episode of oxygen desaturation during treatment | Entirety of hospital admission, approximately 5 days | |
Secondary | Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations | Percentage of participants who achieve normal serum bilirubin concentrations during treatment | Entirety of hospital admission, approximately 5 days |
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