An interventional study of Skylife and Standard Therapy in Jaundice, Neonatal, Neonatal Hyperbilirubinemia and Neonatal Disorder, sponsored by HonorHealth Research Institute. Completed at 2 sites in United States. Open to participants aged 0 Minutes to 7 Minutes. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by HonorHealth Research Institute · Not applicable, Interventional, and Health services research
Phototherapy has served as a primary treatment for hyperbilirubinemia in newborn populations. The light emitted through phototherapy interacts with bilirubin at the skin level to transform it into water-soluble products eliminated in urine and stool. Efficacy of phototherapy relies on the irradiance dispensed at the skin level by the treatment and on the surface area of skin exposed. The purpose of this Investigator-initiated, prospective, two-arm, randomized control investigation is to compare the effect of a novel, newly available, FDA cleared, phototherapy device (Neolight Skylife) with the standard phototherapy treatments used in HonorHealth newborn nurseries (Natus-Neo Blue Blanket and GE Bili Soft Blanket) on healthy, newborns ≥ 35 weeks + 0 days Gestational Age (GA) at the time of birth in the treatment of hyperbilirubinemia. We hypothesize that the unconjugated bilirubin level will be comparably reduced across each treatment arm from baseline to 12 and 24 hour intervals.
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.
93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's enrollment of 72 is below the median of 94 across 59 interventional studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →HonorHealth Research Institute is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
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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'
Exclusion Criteria:
Participants will be screened on the following exclusion criteria at the time of enrollment:
As identified throughout the course of the investigation, additional exclusion criteria include:
Skylife device
Device: Skylife
Standard therapy
Device: Standard Therapy
Newly FDA approved device
Both devices are considered standard therapy
Also known as: Natus-Neo Blue Blanket, GE Bili Soft Blanket
Change in unconjugated bilirubin level from pre-test to post-test
heel stick blood draw for unconjugated bilirubin level
Time frame: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Maintain body temperature between 97.3F and 99.3F
monitor body temperature using a temperature monitoring device
Time frame: 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
visual assessment of the skin for changes
Time frame: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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