Jaundice, Neonatal Clinical Trial
Official title:
Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice
NCT number | NCT05257369 |
Other study ID # | 003PH |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | December 1, 2022 |
Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 14 Days |
Eligibility | Inclusion Criteria: - non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on NICE criteria, gestational age =33 weeks, birth weight =1800 g, postnatal age >24 hrs and =14 days Exclusion Criteria: - hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included. |
Country | Name | City | State |
---|---|---|---|
Armenia | Erebouni Medical Centre, NICU | Yerevan |
Lead Sponsor | Collaborator |
---|---|
Erebouni Medical Center |
Armenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse outcomes | Any adverse effects or patologycal symptoms during phototherapy | "Through study completion, an average of 1 month. | |
Primary | Bilirubin level reduction | Reduction in TSB levels after phototherapy for 24 hours | 24 hours | |
Secondary | Days of phototherapy | Duration of phototherapy | "Through study completion, an average of 1 month. |
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