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A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns

NCT03723005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2023-04-10

No results posted yet for this study

Summary

The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices.

Conditions

  • Hyperbilirubinemia, Neonatal

Interventions

DEVICE

Neolight Phototherapy Mattress

Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.

DEVICE

Standard-of-Care

Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.

Sponsors & Collaborators

Principal Investigators

  • Ronald J Wong, MD · Investigator

Eligibility

Min Age
28 Weeks
Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2023-04-04
Completion
2023-04-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723005 on ClinicalTrials.gov