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

February 19, 2021 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin Healthcare Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Entirety of hospital admission, approximately 5 days
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
Entirety of hospital admission, approximately 5 days
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
Entirety of hospital admission, approximately 5 days
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
Entirety of hospital admission, approximately 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Entirety of hospital admission, approximately 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSR194709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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