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

NCT04021927 | Withdrawn FDA Device

• 1 other identifier: HSR194709
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaundice; Jaundice, Neonatal

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Entirety of hospital admission, approximately 5 days

Secondary Outcomes (1)

• Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations

  Entirety of hospital admission, approximately 5 days

Study Arms (1)

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.

Device: Ring Phototherapy

Interventions

Ring Phototherapy DEVICE

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.

Ring Phototherapy

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Jaundice; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 16, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)