We will assess the (cost-)effectiveness of implementing two interventions in the birth centre setting:1. TcB measurement as a non-invasive screening tool to identify jaundice.2. Application of phototherapy in the birth centre.We hypothesise that…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The two interventions each have their own primary outcome.
1. TcB measurement
The proportion of babies with severe hyperbilirubinaemia within 14 days of
life.
2. Application of phototherapy in the birth centres
The proportion of babies requiring hospital admission for hyperbilirubinaemia
treatment within 14 days of life.
Secondary outcome
Secondary outcomes (all assessed within the first 14 days of life) include:
- highest TSB level.
- proportion of babies having TSB quantified at any time point.
- number of times blood taken for TSB quantification and levels of individual
measurements.
- number of times blood taken for TSB quantification before start of
phototherapy.
- number of times TcB is quantified and levels of individual measurements.
- difference in TcB measurement at forehead and sternum (at same time point).
- proportion of babies receiving phototherapy.
- duration (hours) of phototherapy (if relevant).
- proportion of babies having a TSB level above the exchange transfusion
threshold.(4)
- proportion of babies who actually received an exchange transfusion.
- duration of hospital stay (if relevant).
- number of transfers between PCBCs/hospitals.
- number of times paediatrician consulted and outcome of consultation.
- cost-effectiveness of both interventions.
- experience of parents (based on a questionnaire, see Attachment 4).
The diagnosis of kernicterus will be made by combining clinical signs and
symptoms and additional investigations (e.g. cerebral ultrasound, MRI) in every
infant who had a TSB level above the exchange transfusion threshold level.
Kernicterus is usually not diagnosed within the first 14 days of life. To this
end the medical records of these infants will be requested at the age of one
year at the general practitioner or paediatrician in order to determine the
proportion of babies having kernicterus. This is included in the patient
information sheet and the IC form.
For the group of babies in whom phototherapy should be initiated in the PCBC
the following parameters will be reported as well:
- The proportion of babies in whom phototherapy was initiated in the hospital,
despite inclusion during the intervention period with phototherapy in the PCBC,
including reasons for this hospital admission.
- The proportion of babies requiring subsequent hospital admission for
hyperbilirubinaemia treatment (i.e. after initiation of phototherapy in the
PCBC), including reasons for this *treatment failure*.
Background summary
Jaundice (hyperbilirubinaemia) is a physiological phenomenon in the neonatal
period. However, bilirubin is also neurotoxic and severe hyperbilirubinemia -
when left untreated - may cause kernicterus. Kernicterus is a severe disease,
often leading to long-life handicaps.
Timely recognition of potentially severe jaundice is essential to prevent
kernicterus and its devastating consequences.
According to the Dutch national guideline, jaundice is detected by visual
inspection and - if considered necessary - total serum bilirubin (TSB)
quantification by skin prick. However, visual inspection of jaundice is proven
to be inaccurate.
Transcutaneous bilirubin (TcB) measurement is potentially useful as a screening
tool for hyperbilirubinaemia.
When significant hyperbilirubinaemia is detected, phototherapy offers a
straightforward and safe treatment. In the Netherlands, babies are usually
admitted to the hospital for phototherapy. However, phototherapy in the primary
care setting appears to be safe and effective.
Study objective
We will assess the (cost-)effectiveness of implementing two interventions in
the birth centre setting:
1. TcB measurement as a non-invasive screening tool to identify jaundice.
2. Application of phototherapy in the birth centre.
We hypothesise that among babies admitted in the primary care setting:
1. Non-invasive screening for neonatal jaundice will (cost-)effectively reduce
the incidence of severe hyperbilirubinaemia.
2. In infants requiring treatment for hyperbilirubinaemia, initiation of
phototherapy in the primary care birth centre will (cost-)effectively reduce
the need for hospital admission.
Study design
We will investigate the effectiveness of the two interventions using a
factorial stepped-wedge cluster randomised controlled trial.
Intervention
We will investigate two interventions:
1. TcB measurement as a non-invasive screening tool to identify jaundice.
2. Application of phototherapy in the birth centre.
Study burden and risks
In this study we will investigate two interventions. Both interventions can
only be investigated in newborn babies, since they are the only group suffering
from neonatal hyperbilirubinaemia and receiving phototherapy during the
neonatal phase.
1. TcB measurement as a non-invasive screening tool to identify jaundice.
TcB measurement is safe and has been shown to be effective in reducing the
incidence of severe hyperbilirubinaemia in other settings. TcB measurements
have some inaccuracy which will be taken into account by applying a margin for
the measurement.
There are several potential benefits of TcB screening, including the timely
recognition of jaundice and a decrease in the need for skin pricks to quantify
TSB.
The measurement of TcB is a non-invasive and painless procedure which involves
several seconds of holding the device to the skin. This minimalises the burden.
2. Application of phototherapy in the primary care birth centres.
Phototherapy is a safe and effective intervention to reduce serum bilirubin
levels. It is used as standard practice in the neonatal and paediatric wards.
Phototherapy in the home setting is comparably effective to the hospital
setting.
The indication for phototherapy will be based on national treatment thresholds
and made by a consulted paediatrician at all times.
The benefits of phototherapy in the birth centre are that phototherapy can be
readily instituted if an indication is present and the possibility for parents
and the baby to stay together during phototherapy.
In conclusion, we consider the risks negligible, since the safety and
effectiveness of the interventions have been proven in other settings. Both
interventions have potential to offer major benefits including reducing health
care cost.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Babies are eligible if:
- They were born after 35 completed weeks of gestation.
- They are admitted in a participating PCBC during the study period within the
first week of life.
- They are expected to remain admitted for at least two days (so as to allow
for serial TcB measurements to take place).
- Signed informed consent (IC) is available from parent(s)
Exclusion criteria
Babies are not eligible if:
- They previously received phototherapy (reliability of TcB measurement is
reduced in babies who are receiving or have received phototherapy).
- They have large congenital anomalies at the sternum or forehead.
- Parents do not have sufficient understanding of the Dutch language to be able
to comprehend the patient information sheet.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62027.078.17 |