Keeping jaundiced babies near: the Jauni Care Study 1

Evaluation of the safety, effectiveness and natural care approach of the Jauni phototherapy romper

Jauni is a newly developed phototherapy device for neonatal jaundice treatment integrated in a romper. In this new collaboration between Erasmus MC and Bilihome, manufacturer of Jauni, we will pilot Jauni in jaundiced newborns to generate its first data on safety, effectiveness, and user-convenience. Erasmus MC will thus facilitate Bilihome to further optimise Jauni and work towards its implementation at home. 

The majority of newborn babies experience a degree of jaundice during the first week of life, due to temporary elevation of bilirubin levels. If bilirubin levels are too high, this may lead to potentially severe life-long handicaps. Phototherapy, the first-line treatment for neonatal jaundice, is currently the commonest reason for hospital (re)admission in the neonatal period. Although increasing evidence indicates that phototherapy treatment can also safely and effectively be provided at home, commercially available phototherapy devices have significant drawbacks hampering their widespread implementation. They require connection to mains electricity for example, resulting in physical barrier for parents to provide natural care to their neonate. 

Bilihome has developed Jauni: the first wearable phototherapy device, integrated into a romper. This romper can address the limitations of the current phototherapy devices used at home. In this first in-human pilot study we will assess the effectiveness and safety of Jauni in 12 jaundiced neonates necessitating phototherapy. Additionally, we will explore the experience of parents and healthcare providers regarding Jauni and care for the neonate during phototherapy so as to facilitate future transition to home care for neonatal jaundice. 

This project will provide essential pilot data on Jauni, required to bring Jauni to market. Experiences of parents and healthcare providers will be used to further optimise Jauni and its implementation in daily practice. 

Summary
Severe neonatal jaundice may cause lifelong handicaps, but can be easily treated via phototherapy. Bilihome developed Jauni, the first wearable phototherapy device integrated into a romper, which addresses several drawbacks of other (home) phototherapy devices. This pilot study will be the first to assess Jauni's effectiveness, safety, and user experience.
Technology Readiness Level (TRL)
6 - 7
Time period
12 months
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