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

• ClinicalTrials.gov Identifier: NCT03599258
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Last Update Posted: May 27, 2021
• Sponsor: HonorHealth Research Institute
• Collaborator: Neolight
• Information provided by (Responsible Party): HonorHealth Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Jaundice, Neonatal; Neonatal Hyperbilirubinemia; Neonatal Disorder	Device: Skylife; Device: Standard Therapy	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
• Actual Study Start Date: April 15, 2018
• Actual Primary Completion Date: January 15, 2020
• Actual Study Completion Date: July 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Arm 1; Skylife device	Device: Skylife; Newly FDA approved device
Active Comparator: Arm 2; Standard therapy	Device: Standard Therapy; Both devices are considered standard therapy; Other Names: Natus-Neo Blue Blanket; GE Bili Soft Blanket

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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. ]
   monitor body temperature using a temperature monitoring device
2. 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. ]
   visual assessment of the skin for changes

Eligibility Criteria

• Ages Eligible for Study: up to 7 Minutes (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arizona

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States, 85251

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, United States, 85260

Sponsors and Collaborators

HonorHealth Research Institute

Neolight

Investigators

• Principal Investigator: Matthew Abrams, MD; Affiliated Physician

More Information

• Responsible Party: HonorHealth Research Institute
• ClinicalTrials.gov Identifier: NCT03599258
• Other Study ID Numbers: Skylife-2018-001
• First Posted: July 26, 2018
• Last Update Posted: May 27, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia; Pathologic Processes; Skin Manifestations