NCT03599258

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

Completed NA Last updated 27 May 2021

What this trial tests

NA trial testing Skylife in Jaundice, Neonatal in 72 participants. Completed in 15 July 2020.

Timeline

15 April 2018

Primary endpoint
15 January 2020

15 July 2020

Quick facts

Lead sponsor	HonorHealth Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	72
Start date	15 April 2018
Primary completion	15 January 2020
Estimated completion	15 July 2020
Sites	2 locations across United States

Drugs / interventions tested

• Skylife
• Standard Therapy — full drug profile →

Conditions studied

• Jaundice, Neonatal — all drugs for Jaundice, Neonatal →
• Neonatal Hyperbilirubinemia — all drugs for Neonatal Hyperbilirubinemia →
• Neonatal Disorder — all drugs for Neonatal Disorder →

Sponsor

HonorHealth Research Institute

Who can join

Adults 0 Minutes to 7 Minutes, any sex, with Jaundice, Neonatal or Neonatal Hyperbilirubinemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia.
   Abrams M, Gosselin K, Roth CK, Hoffman N. · · 2024 · PMID 37522330 · DOI 10.1177/00099228231190120