Neonatal Hyperbilirubinemia - Phototherapeutic Treatment Strategies

A randomized clinical study is planned to determine whether there is an upper limit to the efficacy of phototherapy irradiance and whether intermittent/cyclic treatment is as effective as continuous treatment. The study will be conducted at the Maternity Ward and the Department of Pediatrics and Adolescents at the North Denmark Regional Hospital, as well as the Neonatal Department at Aalborg University Hospital. Power calculations require the inclusion of 29 children in each of the four groups, totaling 116 children.

Inclusion criteria are newborns born at ≥33+0 weeks of gestation and a birth weight of ≥1800 g, with a blood bilirubin level above the treatment threshold as specified in the national guidelines. Newborns with rapidly rising bilirubin levels, indicating the need for more intensive treatment with light from multiple sides, exchange transfusion, or possibly immunoglobulin, are excluded from the study.

All children will be treated with double light-overhead light and a light blanket-for 12 hours. The included children will be randomized into one of four groups, each with a specific irradiance level for overhead phototherapy: 40, 55, and 70 µW/cm²/nm. The light blanket under the child will provide an irradiance of 30 µW/cm²/nm. The 70 µW/cm²/nm group will be divided into two subgroups: continuous and intermittent treatment. Thus, there will be four groups in total. Irradiance can be measured and practically adjusted by modifying the distance between the child and the light source. For intermittent treatment, a strategy of 1.5 hours of phototherapy followed by a 1.5-hour pause will be used, based on experiences from other studies and to accommodate the family's and child's feeding needs.

The primary outcome is the reduction in total serum bilirubin, measured from the start of treatment to after 12 hours. Secondary outcomes will include recording whether any children experience a rebound increase in bilirubin. This will be done by reviewing the medical records of the included children to determine if a new blood test for serum bilirubin has been performed, indicating a rebound.

The children will be closely monitored for signs of early bilirubin encephalopathy through medical examinations, weight control, and records of food intake (either breast milk or formula). Serum bilirubin will be measured before the start of treatment. After 12 hours of treatment, serum bilirubin, hemoglobin, and photoisomers will be measured. Serum bilirubin must be measured no more than three hours before the start of phototherapy.