Hyperbilirubinemia, NeonatalNCT03723005
A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
An observational study of Hyperbilirubinemia, Neonatal, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 weeks to 8 months
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Neolight Phototherapy Mattress and Standard-of-Care
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 4 Apr 2023
- Phase
- Observational
- 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 28 weeks to 8 months
- All sexes
- Child
Study population: All infants (not gender or racial/ethnically based) equal or greater than 28 weeks GA and great than 6 hrs of age until hospital discharge.
Who may be able to join
- 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
Who cannot join
- Infant requiring respiratory assistance (such as mechanical ventilation)
- Severe or life-threatening congenital anomalies
- Blood transfusion history
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Neolight Phototherapy Mattress, Standard-of-Care
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neolight Phototherapy MattressDevice
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-CareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neolight Phototherapy Mattress | |
| 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. Receives: Device: Standard-of-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Bilirubin (TB) Levels
Efficacy of each device (neoLight and conventional devices) will be assessed as a decrease in TB levels (in mg/dL/hr) for each infant in each study group
Measured: up to 1 week
Duration of Phototherapy
Efficacy of each device (neoLight and conventional devices) will also be assessed as the duration (in hrs) of phototherapy for each infant in each study group.
Measured: up to 1 week
Secondary outcomes (2)
Irradiance Stability of the neoLight Device
The performance of the neoLight will be assessed as the stability of irradiance emitted by the neoLight device during the use of the device
Measured: 1 year
Infant Temperature Change
Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 May 2018
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- NeoLight, LLC.
- Responsible party
- Principal investigator, David K Stevenson, Stanford University
- Investigators
- Ronald J Wong, MD, Study director, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723005
- Sponsor's protocol ID
- IRB-41341
- Status last verified
- Apr 2023
- First submitted
- 24 Oct 2018
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Sharable statistical data in regards to efficacy of device compared to Standard-of-care devices already used in a hospital setting.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
- ClinicalTrials.gov ID
- NCT03723005
- Acronym / sponsor ID
- IRB-41341
- Conditions
- Hyperbilirubinemia, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- NeoLight, LLC.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 29 Oct 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neolight Phototherapy Mattress | – | Device: Neolight Phototherapy MattressOnce 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 | – | Device: Standard-of-CareOnce 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. |
Who may qualify
- Ages
- 28 weeks to 8 months
- Sex
- All
- Age groups
- Child
- Study population
- All infants (not gender or racial/ethnically based) equal or greater than 28 weeks GA and great than 6 hrs of age until hospital discharge.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Infant requiring respiratory assistance (such as mechanical ventilation)
- Severe or life-threatening congenital anomalies
- Blood transfusion history
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 |
|---|---|---|
| Neolight Phototherapy MattressOnce 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. | Device | Neolight Phototherapy Mattress |
| Standard-of-CareOnce 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. | Device | Standard-of-Care Phototherapy |
Primary outcome
Total Bilirubin (TB) Levels
Time frame: up to 1 week
Efficacy of each device (neoLight and conventional devices) will be assessed as a decrease in TB levels (in mg/dL/hr) for each infant in each study group
Duration of Phototherapy
Time frame: up to 1 week
Efficacy of each device (neoLight and conventional devices) will also be assessed as the duration (in hrs) of phototherapy for each infant in each study group.
2 secondary outcomes
Irradiance Stability of the neoLight Device
Time frame: 1 year
Infant Temperature Change
Time frame: up to 1 week
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 10 Apr 2023.
- Individual participant dataSharing planned: Undecided. Sharable statistical data in regards to efficacy of device compared to Standard-of-care devices already used in a hospital setting.
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
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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.
Ronald J Wong, MD study director
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal, run by Stanford University at 1 site 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 4 inclusion and 3 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Total Bilirubin (TB) Levels (time frame: up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2023.