We will assess safety (potential adverse events related to phototherapy using Jauni, e.g. skin injuries, hyperthermia, or hypothermia) and effectiveness (e.g. rate of lowering of bilirubin levels, duration of phototherapy need) of phototherapy using…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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 cause neurological damage, leading 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. However, increasing evidence indicates that phototherapy
treatment can also safely and effectively be provided at home. This may
overcome high costs associated with hospital admission and help address
increasing challenges regarding hospital capacity, while promoting parent-child
bonding. The current phototherapy devices that may be used in the home setting
- a mattress and a sleeping bag - have significant drawbacks hampering their
widespread implementation. These devices 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.
Study objective
We will assess safety (potential adverse events related to phototherapy using
Jauni, e.g. skin injuries, hyperthermia, or hypothermia) and effectiveness
(e.g. rate of lowering of bilirubin levels, duration of phototherapy need) of
phototherapy using Jauni.
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.
Study design
A prospective single-arm pilot intervention study.
Intervention
Phototherapy using Jauni.
Study burden and risks
In this study, we will assess the safety and effectivity of phototherapy using
Jauni. This study can only be conducted in neonates, since they are the only
group suffering from neonatal hyperbilirubinaemia and necessitating
phototherapy treatment.
Jauni is based on the same technique of blue LED light as commercially
available, widely used conventional phototherapy devices. The risk assessment
of the Jauni device did not show any residual risks of an unacceptable level
after risk control measures were in place. Bilihome has provided a declaration
of safety of the Jauni.
An independent expert will assess safety and effectiveness of Jauni after each
participant that completed phototherapy before the next participant is
included. If the independent expert considers Jauni to be unsafe or
ineffective, the next participant will not be included until the case has been
assessed thoroughly and the independent expert considers Jauni safe and likely
effective for the next participant.
Additionally, phototherapy using Jauni may have advantages. Jauni is developed
to promote the natural care approach during phototherapy. Consequently,
kangaroo care, breastfeeding, and parent-child bonding may be eased in
comparison to conventional phototherapy devices.
In conclusion, we consider the risks of participating in the study low, with
potential advantages: Jauni is based on an existing, proven technique, a safety
declaration is provided by the manufacturer, each neonate is evaluated by an
independent expert, and natural care can potentially be provided more easily.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85903.000.23 |