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

This study is currently recruiting participants.
Verified June 2017 by Pernille Kure Vandborg, University of Aarhus
Sponsor:
ClinicalTrials.gov Identifier:
NCT03183986
First Posted: June 12, 2017
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Aalborg Universitetshospital
Information provided by (Responsible Party):
Pernille Kure Vandborg, University of Aarhus
  Purpose
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.

Condition Intervention
Neonatal Jaundice Device: Phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.

Further study details as provided by Pernille Kure Vandborg, University of Aarhus:

Primary Outcome Measures:
  • Decrease of total serum bilirubin [ Time Frame: 24 hours of phototherapy ]

Estimated Enrollment: 100
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phototherapy 478 nm
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 for 24 hours.
Active Comparator: Phototherapy 459 nm
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
Phototherapy for 24 hours.

Detailed Description:

This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age > 33 weeks and birth weight > 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes.

Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Haemolytic disease
  • Indication for double/triple phototherapy or exchange transfusion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183986


Contacts
Contact: Pernille K Vandborg, MD, PhD + 45 26131711 pervan@rm.dk
Contact: Mette R Donneborg, MD + 45 22406344 mld@rn.dk

Locations
Denmark
Neonatal department, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Mette Donneborg, MD    +45 22406344    mld@rn.dk   
Contact: Finn Ebbesen, Professor, MD    + 45 97663330    fe@rn.dk   
Principal Investigator: Mette Donneborg, MD         
Sub-Investigator: Pernille Vandborg, MD, PhD         
Sub-Investigator: Finn Ebbesen, DmSci         
Sponsors and Collaborators
University of Aarhus
Aalborg Universitetshospital
Investigators
Principal Investigator: Mette Donneborg, MD Aalborg Universitetshospital
  More Information

Publications:
Responsible Party: Pernille Kure Vandborg, Principal investigator, MD, PhD., University of Aarhus
ClinicalTrials.gov Identifier: NCT03183986     History of Changes
Other Study ID Numbers: N-20160071
First Submitted: June 9, 2017
First Posted: June 12, 2017
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases