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

Withdrawn before enrolling · Not applicable

Conditions studied: Jaundice, Jaundice, Neonatal

In brief

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.

Key facts

Study ID

NCT04021927

Run by

University of Minnesota

People needed

0

Starts

2019-09-01

Expected to finish

2021-01-01

Last updated by the study team

2021-02-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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