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Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns

Primary Purpose

Jaundice, Neonatal, Neonatal Hyperbilirubinemia, Neonatal Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skylife
Standard Therapy
Sponsored by
HonorHealth Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Jaundice, Neonatal

Eligibility Criteria

0 Minutes - 7 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HonorHealth Scottsdale Osborn Medical Center
  • HonorHealth Scottsdale Shea Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Skylife device

Standard therapy

Outcomes

Primary Outcome Measures

Change in unconjugated bilirubin level from pre-test to post-test
heel stick blood draw for unconjugated bilirubin level

Secondary Outcome Measures

Maintain body temperature between 97.3F and 99.3F
monitor body temperature using a temperature monitoring device
Absence of skin irritation or ulceration
visual assessment of the skin for changes

Full Information

First Posted
July 11, 2018
Last Updated
May 25, 2021
Sponsor
HonorHealth Research Institute
Collaborators
Neolight
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1. Study Identification

Unique Protocol Identification Number
NCT03599258
Brief Title
Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
Official Title
Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HonorHealth Research Institute
Collaborators
Neolight

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal, Neonatal Hyperbilirubinemia, Neonatal Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Skylife device
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Standard therapy
Intervention Type
Device
Intervention Name(s)
Skylife
Intervention Description
Newly FDA approved device
Intervention Type
Device
Intervention Name(s)
Standard Therapy
Other Intervention Name(s)
Natus-Neo Blue Blanket, GE Bili Soft Blanket
Intervention Description
Both devices are considered standard therapy
Primary Outcome Measure Information:
Title
Change in unconjugated bilirubin level from pre-test to post-test
Description
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.
Secondary Outcome Measure Information:
Title
Maintain body temperature between 97.3F and 99.3F
Description
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.
Title
Absence of skin irritation or ulceration
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
7 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Abrams, MD
Organizational Affiliation
Affiliated Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Scottsdale Osborn Medical Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
HonorHealth Scottsdale Shea Medical Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns

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