Screening and treatment to reduce severe hyperbilirubinaemia in infants in primary care (STARSHIP): a factorial stepped-wedge cluster randomised controlled trial protocol

Berthe van der Geest, JP (Hanneke) de Graaf, L.C.M. Bertens, Marten Poleij, Erwin Ista, R.F. Kornelisse, Irwin Reiss, Eric Steegers, Jasper Been, Martinus Baartmans, J Bekhof, Ron Buijs, JE Bunt, PH Dijk, MC Huizer, CV Hulzebos, Ralph Leunissen, B Pazur, BPW Snoeren, B de VriesWewerinke

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Introduction Jaundice 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 analysis A 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 dissemination This 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.
Original languageEnglish
Article numbere028270
Number of pages10
JournalBMJ Open
Issue number4
Publication statusPublished - Jun 2019

Bibliographical note

This work is supported by a Health Care Efficiency Research grant of The
Netherlands Organisation for Health Research and Development (ZonMw), grant number 843002805, and an Erasmus MC Efficiency Research grant, grant number
2016-16107. The study funders were not involved in the collection, management,
analysis and interpretation of data; writing of the report; or the decision to submit
the report for publication.


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