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

Study Overview
=================
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.

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

Conditions
-----------------
Jaundice, Neonatal, Jaundice

Intervention / Treatment
-----------------
* Device: Ring Phototherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ring Phototherapy<br>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. | Device: Ring Phototherapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |