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ID
Source
Brief title
Health condition
Neonatal jaundice; neonatal hyperbilirubinemia; neonatal hyperbilirubinaemia; neonatale geelzucht; neonatale hyperbilirubinemie; neonatale icterus
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The proportion of neonates with severe hyperbilirubinaemia. Severe hyperbilirubinaemia is defined as a total serum bilirubin level above the mean of the phototherapy and the exchange transfusion threshold according to the Dutch total serum bilirubin nomogram.
2. The proportion of neonates admitted to the hospital for hyperbilirubinaemia treatment.
Secondary outcome
- Highest total serum bilirubin level.
- Proportion of neonates having total serum bilirubin quantified at any time point.
- Number of times blood taken for total serum bilirubin quantification before start of phototherapy.
- Number of times transcutaneous bilirubin is quantified and levels of individual measurements.
- Difference in transcutaneous bilirubin measurement at forehead and sternum (at same time point).
- Proportion of neonates receiving phototherapy.
- Duration (hours) of phototherapy (if relevant).
- Proportion of neonates having a total serum bilirubin level above the exchange transfusion threshold.
- Proportion of neonates who actually received an exchange transfusion.
- Proportion of neonates having kernicterus.
- Duration of hospital stay (if relevant).
- Number of transfers between primary care birth centres/hospitals.
- Number of times paediatrician consulted and outcome of consultation.
- Cost-effectiveness of both interventions.
- Experience of parents (based on a questionnaire).
- Experience of attending health care personnel (based on a questionnaire).
Background summary
Jaundice due to a temporary rise in serum bilirubin levels is a physiological phenomenon in the neonatal period. However, at high levels bilirubin passes the blood-brain barrier and can cause life-long handicaps due to kernicterus. Timely recognition of potentially severe neonatal jaundice is essential, as phototherapy offers a safe and effective treatment. We seek to determine the
(cost-)effectiveness of using transcutaneous bilirubinometry as a non-invasive screening tool for neonatal jaundice in primary care, as well as the (cost-)effectiveness of applying phototherapy in this setting, when indicated, to avoid hospital admission.
Study objective
We hypothesise that among babies admitted to primary care birth centres:
1. Non-invasive screening for neonatal jaundice will (cost-)effectively reduce the incidence of severe hyperbilirubinaemia.
2. Should treatment for hyperbilirubinaemia be indicated, initiation of phototherapy in the primary care birth centre will (cost-)effectively reduce the need for hospital admission.
Study design
The primary outcomes and the secondary outcomes will be defined within the first 14 days of life of the neonate. The only exception is the proportion of neonates having kernicterus, since kernicterus is usually not diagnosed within the first 14 days of life. The proportion of neonates having kernicterus will be defined within the first year of life.
Intervention
1. Repeated transcutaneous bilirubinometry as a screening tool for jaundice and secondary selective measurement of total serum bilirubin.
2. Application of phototherapy in primary care birth centres if hyperbilirubinaemia is present.
Control:
1. Visual assessment of jaundice and selective measurement of total serum bilirubin.
2. Phototherapy in the hospital.
Inclusion criteria
Neonates are eligible if:
- They were born after 35 completed weeks of gestation.
- They are admitted in a participating primary care birth centre during the study period within the first week of life.
- They are expected to remain admitted for at least two days.
- Signed informed consent is available from parent(s).
Exclusion criteria
Neonates are not eligible if:
- They previously 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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6997 |
| NTR-old | NTR7187 |
| CCMO | NL62027.078.17 |
| OMON | NL-OMON55558 |