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

NCT ID: NCT03183986

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-07-01

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.

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.

Conditions

Neonatal Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Phototherapy

Intervention Type: DEVICE

Phototherapy for 24 hours.

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.

Group Type: ACTIVE_COMPARATOR

Phototherapy

Intervention Type: DEVICE

Phototherapy for 24 hours.

Interventions

Phototherapy

Phototherapy for 24 hours.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 25 Hours
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Pernille Kure Vandborg

Principal investigator, MD, PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Donneborg, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Neonatal department, Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Pernille K Vandborg, MD, PhD

Role: CONTACT

pervan@rm.dk

+ 45 26131711

Mette R Donneborg, MD

Role: CONTACT

mld@rn.dk

+ 45 22406344

Facility Contacts

Mette Donneborg, MD

Role: primary

mld@rn.dk

+45 22406344

Finn Ebbesen, Professor, MD

Role: backup

fe@rn.dk

+ 45 97663330

References

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.

Reference Type: BACKGROUND

PMID: 27235206 (View on PubMed)

Other Identifiers

N-20160071

Identifier Type: -

Identifier Source: org_study_id