A multicenter trial conducted in Denmark has demonstrated that the BiliCocoon phototherapy device is as effective as overhead phototherapy in reducing total serum bilirubin (TSB) levels in neonates with hyperbilirubinemia. The study, which involved 83 infants, found no significant difference in TSB reduction between the two methods after 24 hours of treatment. This suggests that BiliCocoon, which uses optic fibers to emit blue LED light, could be a viable alternative to traditional overhead phototherapy.
Study Design and Patient Population
The randomized, open-label trial enrolled healthy neonates (gestational age ≥33 weeks, birth weight ≥1800g, and postnatal age between 24 hours and 14 days) who required phototherapy according to Danish National Guidelines. Infants with rapidly increasing or very high TSB or suspected hemolytic disease were excluded. Participants were randomized to either BiliCocoon (n=42) or overhead phototherapy (neoBLUE, n=41). The primary outcome was the percentage decrease in TSB after 24 hours of phototherapy.
Device Specifications and Irradiance Levels
The BiliCocoon emits blue LED light with a peak emission at 460 nm. The overhead phototherapy device (neoBLUE) emits blue LED light with a peak emission at 458 nm. The level of irradiance was carefully measured and adjusted for both devices to ensure comparability. The mean measured irradiance was approximately 30 µW/cm²/nm for both groups. Notably, the distribution of irradiance differed, with BiliCocoon providing a homogenous distribution and overhead light being highest centrally.
Key Findings
The study found no significant difference in the percentage decrease of TSB between the BiliCocoon and overhead phototherapy groups. The researchers used a random intercept mixed regression model to analyze the data, accounting for hospital centers. A multiple linear regression model was used to adjust the effect of the type of phototherapy on ΔTSB0-24 (%) for factors known from the literature: birth weight, postnatal age, hemoglobin concentration, type of feeding and TSB0. The results indicate that BiliCocoon is non-inferior to overhead phototherapy in reducing TSB levels.
Additional Observations
Unlike overhead phototherapy, the BiliCocoon does not require eye protection, as the neonate's eyes are not directly exposed to the light. Body temperature was monitored throughout the treatment, with hyperthermia defined as a rectal temperature ≥37.5°C and hypothermia as <36.5°C. Parents completed questionnaires regarding time-outs from phototherapy. Data on the need for phototherapy beyond 24 hours and rebound hyperbilirubinemia were also collected.
Clinical Implications
These findings suggest that BiliCocoon is an effective alternative to overhead phototherapy for treating neonatal hyperbilirubinemia. The device's design, which eliminates the need for eye protection, may improve infant comfort and reduce nursing time. Further research may explore the potential benefits of BiliCocoon in different clinical settings and patient populations.
