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

NCT03599258 | Completed FDA Device

• 1 other identifier: Skylife-2018-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Jaundice, Neonatal; Neonatal Hyperbilirubinemia; Neonatal Disorder

Outcome Measures

Primary Outcomes (1)

• Change in unconjugated bilirubin level from pre-test to post-test

  heel stick blood draw for unconjugated bilirubin level

  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

  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

  Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.

Study Arms (2)

Arm 1

OTHER

Skylife device

Device: Skylife

Arm 2

ACTIVE COMPARATOR

Standard therapy

Device: Standard Therapy

Interventions

Skylife DEVICE

Newly FDA approved device

Arm 1

Standard Therapy DEVICE

Both devices are considered standard therapy

Also known as: Natus-Neo Blue Blanket, GE Bili Soft Blanket

Arm 2

Eligibility Criteria

• Age: 0 Minutes - 7 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• Neolight: collaborator

Study Sites (2)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

Location

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States

Location

Related Publications (1)

• 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.

  PMID: 37522330 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Abrams, MD

  Affiliated Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 26, 2018
• Study Start: April 15, 2018
• Primary Completion: January 15, 2020
• Study Completion: July 15, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)