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Non-invasive diagnosis and treatment of neonatal jaundice in primary care

Projectomschrijving

Het is een natuurlijk verschijnsel dat baby's – door een verhoogde bilirubinewaarde in het bloed – enige geelzucht doormaken in de eerste levensdagen. Echter, bilirubine kan bij hoge bloedwaarden schadelijk zijn voor de hersenen. Door ernstige geelzucht op tijd te herkennen en te behandelen kunnen aanzienlijke handicaps voorkomen worden.
In de praktijk wordt geelzucht beoordeeld via de kleur van de huid en door daarna eventueel bloed te prikken. De beoordeling van de kleur van de huid is echter onbetrouwbaar. Via een klein apparaat (huidmeter) kan een betere inschatting worden gemaakt van de ernst van geelzucht. Ernstige geelzucht wordt behandeld door de huid te beschijnen met blauw licht (fototherapie). Fototherapie vindt normaliter plaats in het ziekenhuis.
Onderzocht wordt of door gebruik van de huidmeter en toepassing van fototherapie in eerstelijns geboortecentra ernstige geelzucht en ziekenhuisopnames kunnen worden voorkomen en of op die manier zorgkosten kunnen worden bespaard.

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Samenvatting van de aanvraag

OBJECTIVE/RESEARCH QUESTION Jaundice due to a temporary rise in serum bilirubin (TSB) levels is a physiological phenomenon in the neonatal period. At high levels however, 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 (TcB) 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. Both interventions have significant potential to improve patient outcomes and reduce health-care associated costs. HYPOTHESIS We hypothesise that among babies admitted in a primary care birth centre (PCBC): 1. non-invasive screening for neonatal jaundice will (cost-)effectively reduce the incidence of severe jaundice; and 2. in those requiring jaundice treatment, initiation of phototherapy in the PCBC will (cost-)effectively reduce the need for hospital admission. STUDY DESIGN Factorial stepped-wedge cluster RCT in eight PCBCs. The length of the observational and intervention periods, and the sequence in which both interventions are implemented within individual PCBCs are randomised between centres. STUDY POPULATION/DATASETS Babies born after 35 completed weeks of gestation who are admitted in one of eight PCBCs during at least two days in the first week of life are eligible. Participant data will be prospectively collected; if participants are hospitalised within the first 14 days of life, additional data will be extracted retrospectively from hospital records. INTERVENTION We will study the (cost-)effectiveness of two independent interventions using a factorial design: 1. non-invasive screening for neonatal jaundice using 1-2x daily TcB quantification 2. if treatment of neonatal jaundice is indicated, initiation of phototherapy in the PCBC USUAL CARE/COMPARISON According to the stepped-wedge design implementation of each intervention will be preceded by an observational period of usual care, as informed by the national neonatal jaundice guideline, respectively: 1. visual assessment of neonatal jaundice and selective TSB quantification 2. in-hospital application of phototherapy OUTCOME MEASURES The primary outcomes for the two interventions are: 1. the proportion of babies with severe jaundice (i.e. any TSB level above the median of the levels indicating a need for phototherapy and a need for exchange transfusion, according to the Dutch nomogram) within 14 days of life; and 2. the proportion of babies requiring hospital admission for jaundice treatment within 14 days of life. Cost-effectiveness and a number of secondary clinical outcomes are in addition assessed. Facilitators and barriers to implementation are explored throughout the project. SAMPLE SIZE CALCULATION/DATA ANALYSIS We aim to include 5500 babies in order to identify an expected reduction in severe jaundice from 1.2 to 0.5% points, and in hospital admission for jaundice treatment from 4 to 2% points. Generalised linear mixed models will be used to analyse differences in outcomes and cost-effectiveness ratios will be calculated to assess cost-effectiveness COST-EFFECTIVENESS ANALYSIS/BUDGET IMPACT ANALYSIS A cost-effectiveness analysis (CEA) will be piggybacked onto the RCT. Taking a health care perspective, the CEA will make a comparison between the intervention groups and the control group by identifying, measuring, and valuing the costs and outcomes of the treatment strategies. Cost-effectiveness ratios will be expressed as incremental costs per case of severe jaundice / hospitalisation avoided. A budget impact analysis will be done to show the financial consequences of the introduction of the interventions from the societal perspective (documenting the impact on the national Budgetary Framework Care) and from the perspective of the health care insurers and providers. TIME SCHEDULE We aim to start participant inclusion by October 2017 and finalise inclusion by March 2020. Analysis, dissemination, incorporation in guideline update, exploring opportunities for follow-on projects and grants, and conduction of a model-based estimation of potential cost-effectiveness of expanding the interventions to the home care situation are planned for the final project year. This project has the potential to reduce the incidence of severe neonatal jaundice and the need for hospital admission, and through doing so avoid health-care associated costs. Through informing relevant national guidelines, this can help prevent kernicterus and its devastating consequences.

Onderwerpen

Kenmerken

Projectnummer:
843002805
Looptijd: 100%
Looptijd: 100 %
2017
2022
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
dr. J.V. Been MD PhD
Verantwoordelijke organisatie:
Erasmus Medisch Centrum