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

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ClinicalTrials.gov Identifier: NCT03599258
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Neolight
Information provided by (Responsible Party):
HonorHealth Research Institute

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599258


Contacts
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Contact: Kenneth Fulton 480-323-1973 Kenneth.Fulton@honorhealth.com

Locations
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United States, Arizona
HonorHealth Scottsdale Osborn Medical Center Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Kenneth Fulton    480-323-1973    Kenneth.Fulton@honorhealth.com   
Principal Investigator: Matthew Abrams, MD         
HonorHealth Scottsdale Shea Medical Center Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Kenneth Fulton    480-323-1973    Kenneth.Fulton@honorhealth.com   
Principal Investigator: Matthew Abrams, MD         
Sponsors and Collaborators
HonorHealth Research Institute
Neolight
Investigators
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Principal Investigator: Matthew Abrams, MD Affiliated Physician

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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT03599258     History of Changes
Other Study ID Numbers: Skylife-2018-001
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms