Introduction The resources required to recruit neonatal studies are thought to be greater than for other studies but have not been formally described to date. The aim of this report is to summarise our experience of the effort required to recruit neonates to studies and our success rate with recruitment.
Methods Three contrasting studies were selected from our portfolio. The numbers of babies that were eligible, approached and consented were extracted from our screening logs. The rate of consent among families who were approached was calculated. The time taken for each step was assessed for a selection of families and scaled up for the whole study.
Results Study A was a non-interventional study requiring daily faecal samples. Study B involved taking dried blood spots for pharmacokinetic assays of medication used as routine clinical practice. Study C was a first-in-human study of a novel medicine. Key metrics are summarised in the Table.
The total times spent do not reflect time spent looking for parents or staff.
Discussion Recruitment to neonatal clinical studies requires considerable time, effort and teamwork. The consent rate differs according to the intensity of the study. Funders should take account of screening and recruitment times.