Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/27/2018 |
| Start Date: | April 15, 2018 |
| End Date: | June 2021 |
| Contact: | Kenneth Fulton |
| Email: | Kenneth.Fulton@honorhealth.com |
| Phone: | 480-323-1973 |
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.
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.
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.
Inclusion Criteria:
1. Provision of at least one parent/legal guardian's signed and dated informed consent
form
2. Stated willingness to comply with all study procedures and availability for the
duration of the study
3. Infants born after 35 weeks and 0 days of gestation
4. 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'
1. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of
Gestation (Bhutani Nomogram)
2. 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
We found this trial at
2
sites
Scottsdale, Arizona 85251
Principal Investigator: Matthew Abrams, MD
Phone: 480-323-1973
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9003 East Shea Boulevard
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Principal Investigator: Matthew Abrams, MD
Phone: 480-323-1973
Click here to add this to my saved trials