Newborn Jaundice - An Investigation of Different Approaches to Light Therapy

NCT06702241 | Recruiting Phase 2

• 2 other identifiers: N-20240019F2024-032
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cycled phototherapy; high irradiance phototherapy; Neonatal jaundice; Newborn jaundice; neonatal hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• Total serum bilirubin

  At 12 hours from initiated treatment

Secondary Outcomes (2)

• Re-admissions to the hospital

  14 days after initiation of treatment the patient's file will be examined to determine, if relapse of the conidition has occured

• Breast feeding or formula

  At the initiation and immediately after treatment, as well as during a follow-up telephone call 4 months later.

Study Arms (4)

12 hours continuous double phototherapy with irradiance of over head light of 40 µW/cm2/nm

ACTIVE COMPARATOR

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

12 hours continuous double phototherapy with irradiance of over head light of 55 µW/cm2/nm

ACTIVE COMPARATOR

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

12 hours continuous double phototherapy with irradiance of over head light of 70 µW/cm2/nm

ACTIVE COMPARATOR

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

12 hours cycled double phototherapy with irradiance of over head light of 70 µW/cm2/nm

ACTIVE COMPARATOR

This group will receive 12 hours double phototherapy in cycles of 1,5 hours. Thus receiving 1,5 hours treatment, 1,5 hours pause, 1,5 hours treatment etc.

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

Interventions

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

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

12 hours continuous double phototherapy with irradiance of over head light of 40 µW/cm2/nm

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

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

12 hours continuous double phototherapy with irradiance of over head light of 55 µW/cm2/nm

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

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

12 hours continuous double phototherapy with irradiance of over head light of 70 µW/cm2/nm

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

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

12 hours cycled double phototherapy with irradiance of over head light of 70 µW/cm2/nm

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hyperbilirubinemia with a total serum bilirubin level above the limit of necessary treatment according to the Danish Pediatric Society's guidelines
• Birth weight \>1800g
• Gestational age \>33+0

You may not qualify if:

• Hyperbilirubinemia within the first 24 hours of life
• Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis

Sponsors & Collaborators

• Regionshospital Nordjylland: lead
• Aalborg University Hospital: collaborator

Study Sites (2)

Aalborg University Hospital, The Neonatal Department

Aalborg, 9000, Denmark

RECRUITING

The North Denmark Regional Hospital, The Pediatric Department

Hjørring, 9800, Denmark

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emil L Oehrstroem, MD

CONTACT

+45 24830384; e.oehrstroem@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 22, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)