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
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.
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.
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.