Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.

NCT03183986 | Unknown DMC

• 1 other identifier: N-20160071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance \> 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (1)

• Decrease of total serum bilirubin

  24 hours of phototherapy

Study Arms (2)

Phototherapy 478 nm

ACTIVE COMPARATOR

The jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.

Device: Phototherapy

Phototherapy 459 nm

ACTIVE COMPARATOR

The jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.

Device: Phototherapy

Interventions

Phototherapy DEVICE

Phototherapy for 24 hours.

Phototherapy 459 nm; Phototherapy 478 nm

Eligibility Criteria

• Age: 25 Hours - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Indication for phototherapy with single light
• Gestational age \> 33 weeks
• Birth weight \> 1800 grams
• Should be treatable in a cradle

You may not qualify if:

• Haemolytic disease
• Indication for double/triple phototherapy or exchange transfusion

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Neonatal department, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (1)

• Lamola AA. A Pharmacologic View of Phototherapy. Clin Perinatol. 2016 Jun;43(2):259-76. doi: 10.1016/j.clp.2016.01.004. Epub 2016 Feb 15.

  PMID: 27235206 BACKGROUND

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mette Donneborg, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernille K Vandborg, MD, PhD

CONTACT

+ 45 26131711; pervan@rm.dk

Mette R Donneborg, MD

CONTACT

+ 45 22406344; mld@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD.

Model Details: Infants are randomised to phototherapy with blue LED's with wavelength of 478 or 459 nm. The decrease of TSB between the groups is compared.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)