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NCT03599258 · ClinicalTrials.gov registry record · NA
Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
A NA study, sponsored by HonorHealth Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT03599258 is a NA study that has completed, run by HonorHealth Research Institute. The registered enrollment target is 72 participants.
The verdict
NCT03599258, a NA study, has completed, sponsored by HonorHealth Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Skylife
- DEVICE Standard Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-04-15 |
| Est. Completion | 2020-07-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03599258
The ClinicalTrials.gov registry entry for NCT03599258 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HonorHealth Research Institute, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Skylife is the first listed.
NCT03599258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03599258 about?
NCT03599258 is a clinical study titled "Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns". 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...
What is the current status of trial NCT03599258?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2018-04-15. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT03599258?
The interventions under investigation include: Skylife (DEVICE), Standard Therapy (DEVICE).
Who is sponsoring clinical trial NCT03599258?
This trial is sponsored by HonorHealth Research Institute, which has 20 total clinical trials registered on ClinicalTrials.gov.
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