Screening and treatment to reduce severe hyperbilirubinaemia in infants in primary care (STARSHIP)
| Autor: | van der Geest, Berthe, de Graaf, JP (Hanneke), Bertens, L.C.M., Poleij, Marten, Ista, Erwin, Kornelisse, R.F., Reiss, Irwin, Steegers, Eric, Been, Jasper, Baartmans, Martinus, Bekhof, J, Buijs, Ron, Bunt, JE, Dijk, PH, Huizer, MC, Hulzebos, CV, Leunissen, Ralph, Pazur, B, Snoeren, BPW, de Vries, B, Wewerinke |
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| Přispěvatelé: | Obstetrics & Gynecology, Pediatrics, Health Technology Assessment (HTA), Internal Medicine, Public Health |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Pediatrics medicine.medical_treatment Psychological intervention Exchange transfusion neonatology 03 medical and health sciences primary care 0302 clinical medicine Neonatal Screening Informed consent medicine Protocol Humans 030212 general & internal medicine Neonatology Cluster randomised controlled trial Monitoring Physiologic neonatal jaundice neonatal unconjugated hyperbilirubinemia business.industry Diagnostic Tests Routine Infant Newborn Infant Bilirubin Paediatrics General Medicine Jaundice medicine.disease Jaundice Neonatal Research Design Gestation Kernicterus Female transcutaneous bilirubin measurement medicine.symptom Hyperbilirubinemia Neonatal business 030217 neurology & neurosurgery phototherapy |
| Zdroj: | BMJ Open BMJ Open, 9(4):e028270. BMJ Publishing Group |
| ISSN: | 2044-6055 |
| Popis: | IntroductionJaundice caused by hyperbilirubinaemia is a physiological phenomenon in the neonatal period. However, severe hyperbilirubinaemia, when left untreated, may cause kernicterus, a severe condition resulting in lifelong neurological disabilities. Although commonly applied, visual inspection is ineffective in identifying severe hyperbilirubinaemia. We aim to investigate whether among babies cared for in primary care: (1) transcutaneous bilirubin (TcB) screening can help reduce severe hyperbilirubinaemia and (2) primary care-based (versus hospital-based) phototherapy can help reduce hospital admissions.Methods and analysisA factorial stepped-wedge cluster randomised controlled trial will be conducted in seven Dutch primary care birth centres (PCBC). Neonates born after 35 weeks of gestation and cared for at a participating PCBC for at least 2 days within the first week of life are eligible, provided they have not received phototherapy before. According to the stepped-wedge design, following a phase of ‘usual care’ (visual assessment and selective total serum bilirubin (TSB) quantification), either daily TcB measurement or, if indicated, phototherapy in the PCBC will be implemented (phase II). In phase III, both interventions will be evaluated in each PCBC. We aim to include 5500 neonates over 3 years.Primary outcomes are assessed at 14 days of life: (1) the proportion of neonates having experienced severe hyperbilirubinaemia (for the TcB screening intervention), defined as a TSB above the mean of the phototherapy and the exchange transfusion threshold and (2) the proportion of neonates having required hospital admission for hyperbilirubinaemia treatment (for the phototherapy intervention in primary care).Ethics and disseminationThis study has been approved by the Medical Research Ethics Committee of the Erasmus MC Rotterdam, the Netherlands (MEC-2017-473). Written parental informed consent will be obtained. Results from this study will be published in peer-reviewed journals and presented at (inter)national meetings.Trial registration numberNTR7187. |
| Databáze: | OpenAIRE |
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