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

Recruiting

• Conditions: icterus; Jaundice; 10019654

• Registration Number: NL-OMON56682
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

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 < 5 or umbilical cord pH < 7.0 - ill, drowsy, suspected
infection/sepsis - (albumin < 30 g/Ll, (if determined)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is safe and effective phototherapy treatment using Jauni.<br /><br>Safe treatment is defined as no adverse events that necessitate the switch to a<br /><br>conventional phototherapy device, as indicated by the independent expert.<br /><br>Effective treatment is defined as ability to discontinue phototherapy within 48<br /><br>hours after initiation (i.e. total serum bilirubin level >50 µmol/L below<br /><br>phototherapy threshold according to the Dutch National hyperbilirubinaemia<br /><br>guideline). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Satisfaction of parents (surveyed in semi-structured interview)<br /><br>Satisfaction of healthcare professionals with Jauni (assessed in individual<br /><br>interview immediately after newborn phototherapy treatment).<br /><br><br /><br>Reduction of bilirubin levels in µmol/L/hr during phototherapy with Jauni.<br /><br>Safety indicators (e.g., hypo/hyperthermia, skin redness/rash).<br /><br>(Serious) adverse events<br /><br>Total duration of phototherapy in hours<br /><br>Total duration of hospitalization<br /><br>Percentage of neonates requiring phototherapy with a conventional device<br /><br>Percentage of neonates requiring admission to the neonatology department for<br /><br>phototherapy<br /><br>Percentage of neonates requiring exchange transfusion, according to the Dutch<br /><br>hyperbilirubinemia guideline.</p><br>