Abstract

Much neonatal care is inadequately evidence based because high quality research is lacking. Large, high quality, prospective clinical trials are required to address and reduce the many clinical uncertainties found in neonatal practice. It is however, neither financially or technically feasible to tackle existing neonatal uncertainties using traditional clinical trials.

One promising alternative methodology involves incorporating clinical trials into existing electronic health record systems to facilitate large, simple, efficient neonatal trials; these can be termed “point of care trials”. In the United Kingdom a national resource has been established, the National Neonatal Research Database, which holds clinical data from all infants admitted for neonatal care, extracted from routinely recorded electronic health record data. The United Kingdom is pioneering the use of such routinely recorded electronic data in a prospective neonatal clinical trial examining feeding practices around blood transfusion in very preterm infants. Establishing this trial: WHEAT (WithHolding Enteral feeds Around Transfusion), has involved addressing many barriers faced by such “point of care trials”. These include concerns around incomplete and inaccurate data, research governance and regulatory issues and professional involvement.

Another mechanism to improve the efficiency of neonatal trials is to identify and agree core data items and outcomes to be used in neonatal clinical trials. Such an approach will reduce research waste by facilitating systematic review and meta-analysis of neonatal research, and ensure that the data collected in neonatal research is relevant and important to all stakeholders (such as parents, patients, health professionals and research). The international COIN (Core Outcomes In Neonatology) project is currently working to identify a core outcomes for neonatal research.