NL-OMON56682
Recruiting
Not Applicable
Evaluation of the safety, effectiveness and natural care approach of the Jauni phototherapy romper. - Jauni Care Study 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- icterus
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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