Newborn Jaundice - An Investigation of Different Approaches to Light Therapy

Summary

Background Neonatal jaundice affects about 60% of full-term newborns in their first week. If untreated, it can lead to permanent brain damage. In Denmark, 2-5% of newborns require phototherapy, the standard treatment. The maximum beneficial irradiance limit for phototherapy remains unclear. Furthermore, studies suggest that cycled phototherapy is as effective as continuous treatment.

This study aims to investigate the efficacy of elevating the irradiance of intensive phototherapy treatment regimens. This is to evaluate the dose-response relationship. Furthermore, the study aims to compare intermittent phototherapy to continuous phototherapy.

Methods:

In a clinical randomized multicenter trial 116 newborns with non-hemolytic hyperbilirubinemia, gestational age \>33+0, weight \>1800g and no other significant neonatal diagnose will be randomized. All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW/cm2/nm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW/cm2/nm.

Parental experiences during treatment will be examined through a survey post treatment.

The study has been approved by the Regional Research Ethics Committee.

Perspectives:

Understanding the dose-response relationship of phototherapy will give an insight in the most effective way of treating neonatal jaundice. Intermittent therapy, if proven non-inferior, could facilitate more intimacy in the parent-infant relationship as well as benefits in initiating breastfeeding

Conditions

• Neonatal Hyperbilirubinemia

Interventions

OTHER

Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light

The difference in irradiance between the groups will be measured with a radiometer specific to the device's wavelength.

OTHER

Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light

The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght

OTHER

Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light

The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght

OTHER

Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light

The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• Regionshospital Nordjylland

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

14 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-14

Primary Completion

2027-11-01

Completion

2029-11-01

Countries

• Denmark

Study Locations