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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04021927
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : January 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Jaundice Jaundice, Neonatal Device: Ring Phototherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Ring Phototherapy
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
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 Measures :
  1. Safety of Reflective Ring PT Device: umber of participants who experience fluctuations of body temperature [ Time Frame: Entirety of hospital admission, approximately 5 days ]
    Number of participants who experience fluctuations of body temperature outside the normal range during treatment

  2. Safety of Reflective Ring PT Device: Number of participants who experience apnea [ Time Frame: Entirety of hospital admission, approximately 5 days ]
    Number of participants who experience apnea during treatment

  3. Safety of Reflective Ring PT Device: Number of participants who experience a bradycardic episode [ Time Frame: Entirety of hospital admission, approximately 5 days ]
    Number of participants who experience a bradycardic episode during treatment

  4. Safety of Reflective Ring PT Device: Number of participants who experience an episode of oxygen desaturation [ Time Frame: Entirety of hospital admission, approximately 5 days ]
    Number of participants who experience an episode of oxygen desaturation during treatment


Secondary Outcome Measures :
  1. Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations [ Time Frame: Entirety of hospital admission, approximately 5 days ]
    Percentage of participants who achieve normal serum bilirubin concentrations during treatment



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021927


Contacts
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Contact: Tina M Slusher, MD 612-840-8883 Tina.Slusher@hcmed.org
Contact: Katie Satrom, MD 612-626-0644 ksatrom@umn.edu

Locations
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United States, Minnesota
Hennepin Healthcare Research Institute Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Tina M. Slusher, MD    612-840-8883    Tina.Slusher@hcmed.org   
Sponsors and Collaborators
University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04021927    
Other Study ID Numbers: HSR194709
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: January 16, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Jaundice, Neonatal
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases