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

NCT ID: NCT03599258

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2020-07-15

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.

Conditions

Jaundice, Neonatal; Neonatal Hyperbilirubinemia; Neonatal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1

Skylife device

Group Type: OTHER

Skylife

Intervention Type: DEVICE

Newly FDA approved device

Arm 2

Standard therapy

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: DEVICE

Both devices are considered standard therapy

Interventions

Skylife

Newly FDA approved device

Intervention Type: DEVICE

Standard Therapy

Both devices are considered standard therapy

Intervention Type: DEVICE

Other Intervention Names

Natus-Neo Blue Blanket; GE Bili Soft Blanket

Eligibility 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

• Perinatal asphyxia (Apgar score <4 at 1 minute or <7 at 5 minutes)
• Respiratory distress
• Exchange transfusion
• Major congenital malformations

• 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

• Minimum Eligible Age: 0 Minutes
• Maximum Eligible Age: 7 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neolight

UNKNOWN

Sponsor Role: collaborator

HonorHealth Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Physician

Locations

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37522330 (View on PubMed)

Other Identifiers

Skylife-2018-001

Identifier Type: -

Identifier Source: org_study_id