JaundiceNCT04021927
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
A study testing Ring Phototherapy in people with Jaundice and Jaundice, Neonatal, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Jaundice, Jaundice, Neonatal
- What is being tested?
- Ring Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404
About this study
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.
Read the 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.
- Conditions
- Jaundice, Jaundice, Neonatal
- Being tested
- Ring Phototherapy
- Medical subject headings
- Jaundice, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ring PhototherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ring Phototherapy | Experimental | 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. Receives: Device: Ring Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Entirety of hospital admission, approximately 5 days
Secondary outcomes (1)
Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations
Percentage of participants who achieve normal serum bilirubin concentrations during treatment
Measured: Entirety of hospital admission, approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: Study withdrawn by funding organization with no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JaundiceStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021927
- Sponsor's protocol ID
- HSR194709
- Status last verified
- Feb 2021
- First submitted
- 9 Jul 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
- ClinicalTrials.gov ID
- NCT04021927
- Acronym / sponsor ID
- HSR194709
- Conditions
- Jaundice, Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn by funding organization with no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ring Phototherapy | Experimental | Device: Ring PhototherapyThe 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. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ring PhototherapyThe 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 |
Primary outcome
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
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
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
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
1 secondary outcome
Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations
Time frame: Entirety of hospital admission, approximately 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ring Phototherapy in people with Jaundice and Jaundice, Neonatal, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Reflective Ring PT Device: umber of participants who experience fluctuations of body temperature (time frame: Entirety of hospital admission, approximately 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.