PhD candidate Erasmus MC Rotterdam, Zuid-Holland, Netherlands
Background: Phototherapy, the first line treatment for neonatal jaundice, is the most common reason for hospital (re)admission in the neonatal period. Increasing evidence indicates that phototherapy using a light-emitting diode (LED) device can be safely and effectively applied at home. However, current home devices have limitations, such as requiring mains electricity, which hinders their widespread adoption and natural neonatal care. To address these limitations, Bilihome has developed Jauni: the first wearable phototherapy device, integrated into a romper. Objective: We conducted the first in-human pilot study to evaluate the effectiveness, safety, and user experience of phototherapy using Jauni in near-term neonates with hyperbilirubinemia. Design/Methods: This is an ongoing prospective single-arm pilot intervention study among 12 neonates admitted to the maternity ward of Erasmus MC Sophia Children’s Hospital. Effective treatment was defined as the ability to discontinue phototherapy within 48 hours after initiation. Safe treatment was defined as no adverse events necessitating the switch to a conventional phototherapy device. Secondary outcomes included parental and healthcare providers’ experiences, assessed through semi-structured interviews Results: Nine neonates were included thus far, with a median gestational age of 38 weeks [IQR: 37 – 40] and a median postnatal age of 85 hours [IQR: 76 – 88] at the start of phototherapy. Physiological jaundice was the main cause of jaundice. In eight neonates, phototherapy was successfully completed within 48 hours, with a median phototherapy duration of 24 hours [IQR: 21 – 31] and a median total serum bilirubin reduction rate of -2.25 μmol/l/h [IQR: -4.18 to -1.09]. One neonate was switched to conventional intensive phototherapy by the attending physician, due to ongoing rise of bilirubin levels despite Jauni treatment. No safety issues were recorded in any of the treated neonates. Parents and healthcare providers had an overall positive experience with Jauni, reporting benefits such as mobility, breastfeeding continuation, and providing kangaroo care during treatment.
Conclusion(s): These preliminary data suggest that phototherapy using Jauni is safe and effective in reducing bilirubin levels in most (near)term neonates experiencing hyperbilirubinemia.
