icterus Jaundice
Conditions
Interventions
Phototherapy using Jauni.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - Born at or after a gestational age of 38 weeks. If after participation of six low-risk neonates, the independent expert has not identified any safety issues and effectiveness seems plausible, the eligibility criteria will be extended to also include neonates born between 36 and 38 weeks of gestation. - Total bilirubin level above phototherapy treatment threshold, according to the Dutch guideline or phototherapy indicated by a paediatrician.{[Dutch Paediatric Society] Nederlandse Vereniging voor Kindergeneeskunde, 2023 #328} - Older than 24 hours of postnatal age. - No risk factors* applicable for the subject, according to Dutch guideline.{[Dutch Paediatric Society] Nederlandse Vereniging voor Kindergeneeskunde, 2023 #328} *Risk factors - blood group antagonisms - other haemolytic disorders - asphyxia (AS 5 min
Exclusion criteria
Exclusion criteria: - Conjugated hyperbilirubinaemia (indirect/conjugated bilirubin levels >10 µmol/ L or >20% of total bilirubin level, if known). - Bilirubin level not higher than: ((phototherapy threshold + exchange transfusion threshold) / 2). According to the Dutch guideline. Unless the attending paediatrician decides otherwise based on clinical criteria.{[ Dutch Paediatric Society] Nederlandse Vereniging voor Kindergeneeskunde, 2023 #328}>XX µmol/L above phototherapy treatment threshold. - Neonates having any contraindication for the use of Jauni: - Subjects with congenital erythropoietic porphyria or other photosensitising disorders. - Subjects under photosensitive medication. - Subjects with skin conditions, categorised as unsuitable for an on-skin treatment by a healthcare professional. - Subjects with fever. - The healthcare provider considers the neonate not suitable for phototherapy using Jauni (with reasons noted). - Parents do not provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is safe and effective phototherapy treatment using Jauni. Safe treatment is defined as no adverse events that necessitate the switch to a conventional phototherapy device, as indicated by the independent expert. Effective treatment is defined as ability to discontinue phototherapy within 48 hours after initiation (i.e. total serum bilirubin level >50 µmol/L below phototherapy threshold according to the Dutch National hyperbilirubinaemia guideline). | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction of parents (surveyed in semi-structured interview) Satisfaction of healthcare professionals with Jauni (assessed in individual interview immediately after newborn phototherapy treatment). Reduction of bilirubin levels in µmol/L/hr during phototherapy with Jauni. Safety indicators (e.g., hypo/hyperthermia, skin redness/rash). (Serious) adverse events Total duration of phototherapy in hours Total duration of hospitalization Percentage of neonates requiring phototherapy with a conventional device Percentage of neonates requiring admission to the neonatology department for phototherapy Percentage of neonates requiring exchange transfusion, according to the Dutch hyperbilirubinemia guideline. | — |
Countries
Netherlands
Outcome results
None listed