Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy

Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy

Sponsors

Lead Sponsor: University of Minnesota

Source University of Minnesota
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.

Overall Status Recruiting
Start Date September 1, 2019
Completion Date December 1, 2021
Primary Completion Date December 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety of Reflective Ring PT Device: umber of participants who experience fluctuations of body temperature Entirety of hospital admission, approximately 5 days
Safety of Reflective Ring PT Device: Number of participants who experience apnea Entirety of hospital admission, approximately 5 days
Safety of Reflective Ring PT Device: Number of participants who experience a bradycardic episode Entirety of hospital admission, approximately 5 days
Safety of Reflective Ring PT Device: Number of participants who experience an episode of oxygen desaturation Entirety of hospital admission, approximately 5 days
Secondary Outcome
Measure Time Frame
Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations Entirety of hospital admission, approximately 5 days
Enrollment 150
Condition
Intervention

Intervention Type: Device

Intervention Name: Ring Phototherapy

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.

Arm Group Label: Ring Phototherapy

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.

Gender: All

Minimum Age: N/A

Maximum Age: 7 Days

Healthy Volunteers: No

Overall Contact

Last Name: Tina M Slusher, MD

Phone: 612-840-8883

Email: [email protected]

Location
Facility: Status: Contact: Hennepin Healthcare Research Institute Tina M. Slusher, MD 612-840-8883 [email protected]
Location Countries

United States

Verification Date

January 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ring Phototherapy

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov