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

Jaundice, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599258
• Other study ID #: Skylife-2018-001
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: May 2021
• Source: HonorHealth Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Infant, Newborn, Diseases
• Jaundice
• Jaundice, Neonatal
• Neonatal Disorder
• Neonatal Hyperbilirubinemia

Intervention

Device:
• Skylife
Newly FDA approved device
• Standard Therapy
Both devices are considered standard therapy

Locations

Country	Name	City	State
United States	HonorHealth Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	HonorHealth Scottsdale Shea Medical Center	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
HonorHealth Research Institute	Neolight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maintain body temperature between 97.3F and 99.3F	monitor body temperature using a temperature monitoring device	Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Secondary	Absence of skin irritation or ulceration	visual assessment of the skin for changes	Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.