Neonatal Hyperbilirubinemia - Phototherapeutic Treatment Strategies

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 14 days
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital, The Neonatal Department
RECRUITING
Aalborg
The North Denmark Regional Hospital, The Pediatric Department
RECRUITING
Hjørring
Contact Information
Primary
Emil L Oehrstroem, MD
e.oehrstroem@rn.dk
+45 24830384
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2029-11-01
Participants
Target number of participants: 116
Treatments
Active_comparator: 12 hours continuous double phototherapy with irradiance of over head light of 40 µW/cm2/nm
Active_comparator: 12 hours continuous double phototherapy with irradiance of over head light of 55 µW/cm2/nm
Active_comparator: 12 hours continuous double phototherapy with irradiance of over head light of 70 µW/cm2/nm
Active_comparator: 12 hours cycled double phototherapy with irradiance of over head light of 70 µW/cm2/nm
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.
Sponsors
Leads: Regionshospital Nordjylland
Collaborators: Aalborg University Hospital

This content was sourced from clinicaltrials.gov