Broad Band Emission LED Phototherapy Source Versus Narrow Band

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257369
• Other study ID #: 003PH
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2022
• Source: Erebouni Medical Center
• Contact: Pavel Mazmanyan, Prof
• Phone: +37491416589
• Email: pavelart[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

Device:
• Blue-Green LED photoherapy
Continuous phototherapy for 24 h, for newborns placed incubators or radiant warmers will interrupted only for feeding and nursing for 20 - 30 min every three hours.

Locations

Country	Name	City	State
Armenia	Erebouni Medical Centre, NICU	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Erebouni Medical Center

Country where clinical trial is conducted

Armenia, 

Outcome

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.