Comparison of the Efficacy of Phototherapy Using Blue LED... | NCT03183986

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

NCT03183986

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jun 20, 2017Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Neonatal Jaundice

Interventions

Phototherapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Mar 1, 2018Estimated

Completion Date

Jul 1, 2018Estimated

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 20, 2017Actual

Name	Class
Aalborg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Phototherapy	Device	Phototherapy for 24 hours.	Phototherapy 459 nm Phototherapy 478 nm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease of total serum bilirubin		24 hours of phototherapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Hours

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pernille K Vandborg, MD, PhD	Contact	+ 45 26131711		pervan@rm.dk
Mette R Donneborg, MD	Contact	+ 45 22406344		mld@rn.dk

Overall Officials

Name	Affiliation	Role
Mette Donneborg, MD	Aalborg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatal department, Aalborg University Hospital	Recruiting	Aalborg		9000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27235206	Background	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.

ID	Term
D051556	Hyperbilirubinemia, Neonatal
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006932	Hyperbilirubinemia