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.
Data analysis will examine:
Differences between the three groups with varying light intensities. Differences between
the two groups with the same irradiance but differing treatment regimens (intermittent
vs. continuous).
Parents of children meeting the inclusion criteria will be presented with the project
verbally and in writing by department staff in a quiet, undisturbed setting. Parents will
have time to consider the project while awaiting blood test results and preparing for
phototherapy. If parents cannot agree or decide, the child will not participate in the
project.
The project is registered with the Research Projects Registry of the North Denmark Region
(ID: F2024-032). The project is approved by the Danish Scientific Ethical Committee for
Region North Jutland, registration number N-20240019.
Perspectives The study aims to enable more effective and shorter treatment for the 2-5%
of all newborns receiving phototherapy. This will allow for more time to establish
breastfeeding and bonding between the child and parent.