NCT02154165

Brief Summary

The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S). The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age \> 33 weeks and uncomplicated hyperbilirubinemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

May 30, 2014

Last Update Submit

June 2, 2014

Conditions

Uncomplicated Neonatal Hyperbilirubinemia

Keywords

Neonatal hyperbilirubinemiaPhototherapyLight emitting diodesBlue lightTurquoise light

Outcome Measures

Primary Outcomes (1)

  • Decrease in total serum bilirubin

    The infants were treated with phototherapy for 24 hours, which is the standard treatment.

    24 hours

Study Arms (2)

Blue light wavelenght 460 nm

ACTIVE COMPARATOR
Other: Phototherapy

Turquoise light wavelength 499 nm

ACTIVE COMPARATOR
Other: Phototherapy

Interventions

PhototherapyOTHER

The infants were randomized to phototherapy with either blue og turquoise light

Blue light wavelenght 460 nmTurquoise light wavelength 499 nm

Eligibility Criteria

Age33 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborns with gestational age \>33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines

You may not qualify if:

  • Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis)
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal department, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations

DK(1)