Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
Primary Purpose
Jaundice, Jaundice, Neonatal
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ring Phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Jaundice
Eligibility Criteria
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.
Sites / Locations
- Hennepin Healthcare Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ring Phototherapy
Arm Description
The product will be an open-faced ring device with an angular reflective surface that redirects unused light sideways onto the neonate's body illuminating previously unexposed regions where treatable bilirubin exists while protecting the baby from head roll with an inner transparent corral. This device is superior to current PT devices because it converts existing waste light into treatment efficacy while integrating into existing single overhead lamp systems avoiding the purchase of secondary devices that are expensive and create hospital system complexity and inefficiency issues.
Outcomes
Primary Outcome Measures
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
Safety of Reflective Ring PT Device: Number of participants who experience apnea
Number of participants who experience apnea during treatment
Safety of Reflective Ring PT Device: Number of participants who experience a bradycardic episode
Number of participants who experience a bradycardic episode during treatment
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
Secondary Outcome Measures
Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations
Percentage of participants who achieve normal serum bilirubin concentrations during treatment
Full Information
NCT ID
NCT04021927
First Posted
July 9, 2019
Last Updated
February 19, 2021
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04021927
Brief Title
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
Official Title
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn by funding organization with no participants enrolled
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 hospital admission will be eligible for enrollment after informed parental consent.
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 related complications like Kernicterus Spectrum Disorder (KDS) are gaining recognition among the world's health policy leaders as an important area for further research and development. The long-term sequelae of KSD include choreoathetoid cerebral palsy, sensorineural hearing loss, and upward gaze palsy. KSD is irreversible resulting in a lifetime of physical, emotional, social and economic challenges. Access to cost-effective methods of improving pediatric jaundice care along with improved circumferential (full body) illumination technologies is an affirmed objective of the AAP (American Academy of Pediatrics). The investigators hypothesize that unused therapy light (irradiance) surrounding the neonate using an existing single-lamp bank phototherapy (PT) device is sufficient in quantity and if redirected onto the patients untreated or poorly illuminated skin surfaces, it will accelerate metabolism and excretion of bilirubin. This PT ring device redirects unused phototherapy light sideways onto the neonate body using an open-faced ring approach. The technology will illuminate previously unexposed and poorly exposed skin regions where treatable bilirubin exists. The device is superior to current PT devices in that it converts existing waste light into treatment efficacy while integrating into existing overhead lamp systems offsetting the purchase of secondary devices that are often unaffordable and create hospital complexity, cost and inefficiency issues. A further benefit of the device will be reduced ambient blue-light spillover in patient care areas, an ongoing concern for medical staff.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Jaundice, Neonatal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ring Phototherapy
Arm Type
Experimental
Arm Description
The product will be an open-faced ring device with an angular reflective surface that redirects unused light sideways onto the neonate's body illuminating previously unexposed regions where treatable bilirubin exists while protecting the baby from head roll with an inner transparent corral. This device is superior to current PT devices because it converts existing waste light into treatment efficacy while integrating into existing single overhead lamp systems avoiding the purchase of secondary devices that are expensive and create hospital system complexity and inefficiency issues.
Intervention Type
Device
Intervention Name(s)
Ring Phototherapy
Intervention Description
The product will be an open-faced ring device with an angular reflective surface that redirects unused light sideways onto the neonate's body illuminating previously unexposed regions where treatable bilirubin exists while protecting the baby from head roll with an inner transparent corral. This device is superior to current PT devices because it converts existing waste light into treatment efficacy while integrating into existing single overhead lamp systems avoiding the purchase of secondary devices that are expensive and create hospital system complexity and inefficiency issues.
Primary Outcome Measure Information:
Title
Safety of Reflective Ring PT Device: umber of participants who experience fluctuations of body temperature
Description
Number of participants who experience fluctuations of body temperature outside the normal range during treatment
Time Frame
Entirety of hospital admission, approximately 5 days
Title
Safety of Reflective Ring PT Device: Number of participants who experience apnea
Description
Number of participants who experience apnea during treatment
Time Frame
Entirety of hospital admission, approximately 5 days
Title
Safety of Reflective Ring PT Device: Number of participants who experience a bradycardic episode
Description
Number of participants who experience a bradycardic episode during treatment
Time Frame
Entirety of hospital admission, approximately 5 days
Title
Safety of Reflective Ring PT Device: Number of participants who experience an episode of oxygen desaturation
Description
Number of participants who experience an episode of oxygen desaturation during treatment
Time Frame
Entirety of hospital admission, approximately 5 days
Secondary Outcome Measure Information:
Title
Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations
Description
Percentage of participants who achieve normal serum bilirubin concentrations during treatment
Time Frame
Entirety of hospital admission, approximately 5 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hennepin Healthcare Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
We'll reach out to this number within 24 hrs