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
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
Hyperbilirubinemia within the first 24 hours of life
Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis
Parallel
Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light
Other interventionThe difference in irradiance between the groups will be measured with a radiometer specific to the device's wavelength.
Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light
Other interventionThe difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght
Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light
Other interventionThe difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght
Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light
Other interventionThe difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght
Total serum bilirubin
Re-admissions to the hospital
Breast feeding or formula
A description of the newborn's nutrition will be noted comparing cycled and continuous phototherapy. This is relevant because in continuous (standard) treatment the infant spends longer periods away from the parent thus making the establishment of breast feeding more difficult
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Regionshospital Nordjylland
Lead sponsor
Aalborg University Hospital
Collaborator
