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

Abstract

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.

Assessing knowledge and skills of maternity care professionals regarding neonatal hyperbilirubinaemia: a nationwide survey

“…Training sessions on neonatal hyperbilirubinaemia were provided to MCAs as part of the STARSHIP Trial [ 15 ]. Training sessions were aimed at increasing knowledge on pathophysiology, risk factors, recognition and treatment of neonatal hyperbilirubinaemia, and at providing information on STARSHIP study procedures (e.g.…”

“…We conducted a nationwide online survey among MCAs in the Netherlands to assess their knowledge regarding neonatal hyperbilirubinaemia and their skills regarding its assessment. In addition, from MCAs working in primary care and participating in training sessions provided as part of the Screening and TreAtment to Reduce Severe Hyperbilirubinaemia in Infants in Primary care (STARSHIP) Trial (NTR7187), we collected paper-based questionnaires assessing knowledge on hyperbilirubinaemia and on STARSHIP study procedures [15]. The STARSHIP Trial is an ongoing factorial stepped-wedge cluster randomised controlled trial aimed at assessing the effectiveness of: 1. daily TcB screening to reduce the incidence of severe hyperbilirubinaemia, and 2. phototherapy provided in primary care birth centres to reduce the number of neonates admitted to hospital for hyperbilirubinaemia treatment [15,16].…”

Assessment, management, and incidence of neonatal jaundice in healthy neonates cared for in primary care: a prospective cohort study

“…The Screening and TreAtment to Reduce Severe Hyperbilirubinaemia in Primary care (STARSHIP) Trial is an ongoing factorial stepped-wedge cluster randomised controlled trial in seven Dutch primary care birth centres (PCBCs). It aims to assess the effectiveness of universal transcutaneous bilirubin (TcB) screening and of phototherapy applied in primary care 18 . See Text Box 2 .…”

Aplicación del bilirrubinómetro no invasivo en recién nacidos

“…Y que la combinación de BTc y BST predijo en el 84% de los casos la identificación del riesgo de hiperbilirrubinemia antes del alta que necesitaron ser tratadas con luminoterapia. Al agregársele factores de riesgo el (8,5,19) AUC (área under curve) fue de 0,92 .…”