Jaundice, NeonatalNCT03599258
Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
A study testing Skylife and Standard Therapy in people with Jaundice, Neonatal and Neonatal Hyperbilirubinemia, run by HonorHealth Research Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 7 minutes
- Conditions the study is for
- Jaundice, Neonatal, Neonatal Hyperbilirubinemia, Neonatal Disorder
- What is being tested?
- Skylife and Standard Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2018to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 7 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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:
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
About this study
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.
Read the 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.
- Being tested
- Skylife, Standard Therapy
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkylifeDevice
Newly FDA approved device
Standard TherapyDevice
Also called Natus-Neo Blue Blanket, GE Bili Soft Blanket
Both devices are considered standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Skylife device Receives: Device: Skylife |
| Arm 2 | Active comparator | Standard therapy Receives: Device: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in unconjugated bilirubin level from pre-test to post-test
heel stick blood draw for unconjugated bilirubin level
Measured: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Secondary outcomes (2)
Maintain body temperature between 97.3F and 99.3F
monitor body temperature using a temperature monitoring device
Measured: 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
Measured: Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Apr 2018
- Primary completion15 Jan 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Neolight
- Responsible party
- Sponsor
- Investigators
- Matthew Abrams, MD, Principal investigator, Affiliated Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599258
- Sponsor's protocol ID
- Skylife-2018-001
- Status last verified
- May 2021
- First submitted
- 11 Jul 2018
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abrams M, Gosselin K, Roth CK, Hoffman N. A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia. Clin Pediatr (Phila). 2024 Jun;63(6):774-778. doi: 10.1177/00099228231190120. Epub 2023 Jul 31.
PubMed 37522330
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
- ClinicalTrials.gov ID
- NCT03599258
- Acronym / sponsor ID
- Skylife-2018-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Collaborators
- Neolight
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: SkylifeSkylife device |
| Arm 2 | Active comparator | Device: Standard TherapyStandard therapy |
Who may qualify
- Ages
- 0 to 7 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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'
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkylifeNewly FDA approved device | Device | Arm 1 |
| Standard TherapyAlso: Natus-Neo Blue Blanket, GE Bili Soft BlanketBoth devices are considered standard therapy | Device | Arm 2 |
Primary outcome
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 37522330Abrams M, Gosselin K, Roth CK, Hoffman N. A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia. Clin Pediatr (Phila). 2024 Jun;63(6):774-778. doi: 10.1177/00099228231190120. Epub 2023 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Abrams, MD principal investigator
Affiliated Physician
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skylife and Standard Therapy in people with Jaundice, Neonatal and Neonatal Hyperbilirubinemia, run by HonorHealth Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.