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出境医 / 临床实验 / 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
Study Description
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | N/A |
| 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 |
| Actual Primary Completion Date : | January 1, 2021 |
| Actual Study Completion Date : | January 1, 2021 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Eligibility Criteria
| 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.
Contacts and Locations
Locations
| United States, Minnesota | |
| Hennepin Healthcare Research Institute | |
| Minneapolis, Minnesota, United States, 55404 | |
Sponsors and Collaborators
University of Minnesota
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 9, 2019 | ||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||
| Last Update Posted Date | February 23, 2021 | ||||||
| Actual Study Start Date ICMJE | September 1, 2019 | ||||||
| Actual Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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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| Original Secondary Outcome Measures ICMJE |
Efficacy: 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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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy | ||||||
| Official Title ICMJE | Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy | ||||||
| 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
| Condition ICMJE |
|
||||||
| Intervention ICMJE | 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.
|
||||||
| Study Arms ICMJE | 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.
Intervention: Device: Ring Phototherapy
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Withdrawn | ||||||
| Actual Enrollment ICMJE |
0 | ||||||
| Original Estimated Enrollment ICMJE |
150 | ||||||
| Actual Study Completion Date ICMJE | January 1, 2021 | ||||||
| Actual Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | up to 7 Days (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04021927 | ||||||
| Other Study ID Numbers ICMJE | HSR194709 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | University of Minnesota | ||||||
| Study Sponsor ICMJE | University of Minnesota | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | University of Minnesota | ||||||
| Verification Date | February 2021 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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