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

NCT ID: NCT03723005

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2023-04-04

Brief 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.

Detailed Description

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. It is believed that this device will not only avoid many of the side effects when fluorescent tube lights are used, since it delivers safer, non-ultraviolet light; but may also be more effective than currently-used blankets or mattresses, which use blue halogen lamps or fluorescent tubes as light sources. The light is emitted under the baby. This study will discover if this device should be used in place of the currently-used devices.

Conditions

Hyperbilirubinemia, Neonatal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Neolight Phototherapy Mattress

Intervention Type: DEVICE

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.

Standard-of-Care Phototherapy

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.

Standard-of-Care

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male and female newborns greater of equal to 28 weeks GA
• Parental informed consent
• Enrollment at age greater than 6 hrs of age until neonatal discharge
• Phototherapy routine order

Exclusion Criteria

• Infant requiring respiratory assistance (such as mechanical ventilation)
• Severe or life-threatening congenital anomalies
• Blood transfusion history

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 8 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeoLight, LLC.

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David K Stevenson

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald J Wong, MD

Role: STUDY_DIRECTOR

Investigator

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

IRB-41341

Identifier Type: -

Identifier Source: org_study_id