This pilot study aimed to assess the effectiveness and safety of the first wearable phototherapy device in (near-)term neonates with unconjugated hyperbilirubinaemia. This prospective single-arm intervention pilot study was conducted in the Erasmus MC Sophia Children’s Hospital maternity ward and the Primary Care Birth Centre Sophia in Rotterdam, the Netherlands. Twelve (near-)term neonates with hyperbilirubinaemia requiring treatment, according to the Dutch national hyperbilirubinaemia guideline, were treated with wearable phototherapy. Results were compared to a matched historical cohort of neonates treated with BiliSoft. Effective and safe treatment was defined by (1) the ability to discontinue phototherapy within 48 h after initiation and (2) no adverse events that necessitate switching to a conventional phototherapy device, as indicated by an independent expert. Twelve neonates were included, with a median gestational age of 38.5 weeks (IQR 37.9–39.2) and a median postnatal age of 77 h (IQR 58–87). In ten neonates (83%), phototherapy was successfully completed within 48 h, with a median phototherapy duration of 23 h (IQR 22.5–30.3) and a median TSB reduction rate of 1.8 µmol/L/h (IQR 2.3–1.1). These findings were similar in the control group. Two neonates were switched to conventional intensive phototherapy due to the ongoing rise of bilirubin levels despite wearable phototherapy treatment. No safety issues were recorded. Parents and healthcare providers reported positive experiences, highlighting benefits such as mobility and increased parental autonomy.

Conclusion: This pilot study provides data to indicate that wearable phototherapy is effective and safe in reducing bilirubin levels in the majority of (near-)term neonates with hyperbilirubinaemia.

The aim of this study was to investigate the association between the implementation of a local heart rate variability (HRV) monitoring guideline combined with determination of inflammatory biomarkers and mortality, measures of sepsis severity, frequency of sepsis testing, and antibiotic usage, among very preterm neonates. In January 2018, a guideline was implemented for early detection of late-onset neonatal sepsis using HRV monitoring combined with determination of inflammatory biomarkers. Data on all patients admitted with a gestational age at birth of < 32 weeks were reviewed in the period January 2016–June 2020 (n = 1,135; n = 515 pre-implementation, n = 620 post-implementation). Outcomes of interest were (sepsis-related) mortality, sepsis severity (neonatal sequential organ failure assessment (nSOFA)), sepsis testing, and antibiotic usage. Differences before and after implementation of the guideline were assessed using logistic and linear regression analysis for binary and continuous outcomes respectively. All analyses were adjusted for gestational age and sex. Mortality within 10 days of a sepsis episode occurred in 39 (10.3%) and 34 (7.6%) episodes in the pre- and post-implementation period respectively (P = 0.13). The nSOFA course during a sepsis episode was significantly lower in the post-implementation group (P = 0.01). We observed significantly more blood tests for determination of inflammatory biomarkers, but no statistically significant difference in number of blood cultures drawn and in antibiotic usage between the two periods.

Conclusion: Implementing HRV monitoring with determination of inflammatory biomarkers might help identify patients with sepsis sooner, resulting in reduced sepsis severity, without an increased use of antibiotics or number of blood cultures.