- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599258
Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
Study Overview
Status
Intervention / Treatment
Detailed Description
This is an investigator-initiated, prospective, two-arm randomized control investigation to examine the mean values in patients' unconjugated bilirubin level for a new, FDA cleared device (Neolight Skylife) with the standard phototherapy treatment. Patient data on unconjugated bilirubin level, pressure ulcer and body temperature will be evaluated at baseline, 12-hours post-intervention, 24 hours post-intervention and at discharge.
Neolight Skylife is a compact device that offers phototherapy to infants across all neonatal beds, supplanting multiple, enclosure specific phototherapy devices. Neolight Skylife weighs less than 10 lbs. and is ergonomically designed for portability that allows for easy carrying of the device between beds. Neolight Skylife offers the choice between treatment intensity levels. Neolight Skylife utilizes blue Light-Emitting Diodes (LEDs) to achieve low irradiance of 30 plus or minus 5 μw/cm²/nm, and high irradiance of 45 plus or minus 10, μw/cm²/nm. Neolight Skylife emits light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for treatment. Neolight Skylife eliminates the risk of UV exposure typically seen with phototherapy treatment through the use of blue LEDs, as this light source does not emit significant energy in the ultraviolet (UV) spectrum. However, as with all phototherapy treatment, protective eye coverings are used to protect the baby's eyes from excessive light exposure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Scottsdale, Arizona, United States, 85251
- HonorHealth Scottsdale Osborn Medical Center
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Scottsdale, Arizona, United States, 85260
- HonorHealth Scottsdale Shea Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of at least one parent/legal guardian's signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Infants born after 35 weeks and 0 days of gestation
Infants who developed significant hyperbilirubinemia Infants who developed significant hyperbilirubinemia per BiliToolTM plot requiring phototherapy as determined by the attending neonatologist utilizing the American Academy of Pediatrics'
- Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (Bhutani Nomogram)
- Guidelines for Phototherapy in Hospitalized Infants of 35 or More Weeks Gestation
Exclusion Criteria:
Participants will be screened on the following exclusion criteria at the time of enrollment:
- Perinatal asphyxia (Apgar score <4 at 1 minute or <7 at 5 minutes)
- Respiratory distress
- Exchange transfusion
- Major congenital malformations
As identified throughout the course of the investigation, additional exclusion criteria include:
- Direct-reacting component of bilirubin >2 mg/dL
- Glucose-6-phosphate deficiency
- ABO incompatibility
- Evidence of hemolysis
- Evidence of sepsis
- Rhesus hemolytic disease
- Pyruvate kinase deficiency
- Severe dehydration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Arm 1
Skylife device
|
Newly FDA approved device
|
ACTIVE_COMPARATOR: Arm 2
Standard therapy
|
Both devices are considered standard therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in unconjugated bilirubin level from pre-test to post-test
Time Frame: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
|
heel stick blood draw for unconjugated bilirubin level
|
Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintain body temperature between 97.3F and 99.3F
Time Frame: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
|
monitor body temperature using a temperature monitoring device
|
Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
|
Absence of skin irritation or ulceration
Time Frame: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
|
visual assessment of the skin for changes
|
Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Abrams, MD, Affiliated Physician
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Skylife-2018-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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