Background For policy makers to implement a screening programme, it should undergo testing to demonstrate efficacy and cost-effectiveness. When testing a screening intervention, the study design has nuances compared to conventional randomised controlled trials (RCTs). Important considerations include the timing and technique of the randomisation and consent process.

Newborn screening seeks to screen a baby for serious conditions within the first eight weeks of life. This is a broad field encompassing a variety of diseases, mainly rare conditions. There is growing interest in childhood screening among politicians in countries such as the UK, and leading organisations including the World Health Organisation (WHO). Clinical trials in newborn screening have the added complexity that consent is sought from parents to test their child. This study aims to undertake a scoping review of RCTs in newborn screening to summarise the trial designs, with particular reference to randomisation and consent processes.

Methods The search will be carried out on OVIDMEDLINE, EMBASE, CINAHL and CENTRAL databases. Clinical trials registries, approved by the International Committee of Medical Journal Editors (ICMJE) and the WHO clinical trial registry, will be searched for any studies registered. Additionally in those studies that are included any citing or cited literature will be searched for any relevant studies.

Discussion This study is the first scoping review of its kind. Synthesis of the available evidence will enable investigators to better consider the nuances of undertaking screening trials among newborns when designing future evaluations of screening programmes in children.

JSB works for GE Healthcare, and previously consulted/worked for AutonomUS Medical Technologies and Intelligent Ultrasound. He has received speaker fees from the Belgian Association of Regional Anaesthesia, as well as King Fiasal Specialist Hospital and Research Centre STP: Member of the UK National Screening Committee, NIHR research professor DP: national clinical advisor for hip screening to the NHS England antenatal and newborn programme advisory group, NIHR research professor

This study did not receive any funding

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