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…
ID
Bron
Verkorte titel
Aandoening
Neonatal jaundice; neonatal hyperbilirubinemia; neonatal hyperbilirubinaemia; neonatale geelzucht; neonatale hyperbilirubinemie; neonatale icterus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.<br>
2. The proportion of neonates admitted to the hospital for hyperbilirubinaemia treatment.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6997 |
| NTR-old | NTR7187 |
| CCMO | NL62027.078.17 |
| OMON | NL-OMON55558 |