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

Completed · Not applicable

Conditions studied: Jaundice, Neonatal, Neonatal Hyperbilirubinemia, Neonatal Disorder

In brief

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.

Key facts

Study ID

NCT03599258

Run by

HonorHealth Research Institute

People needed

72

Starts

2018-04-15

Expected to finish

2020-07-15

Last updated by the study team

2021-05-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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…

• 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

Where it is running

• HonorHealth Scottsdale Osborn Medical Center — Scottsdale, Arizona, United States
• HonorHealth Scottsdale Shea Medical Center — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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