Background Genetic risk variants and preterm birth are early and potent risk factors for later neuropsychiatric disorders. To understand the interrelationships between these factors, a large-scale genetic study of very preterm (VPT, <32 weeks gestation) infants with prospective follow-up is required. In this paper, we describe a streamlined study approach, using efficient processes for biological and clinical data collection, to feasibly establish such a cohort.
Methods We sought to recruit 500 VPT families within a 1 year period from neonatal units. Treating clinical teams recruited eligible participants, obtained parent consent, collected blood samples and posted specimens to the research laboratory. We extracted all clinical data from the National Neonatal Research Database, an existing UK resource that captures daily patient-level data on all VPT infants.
Results Between May 2017 and June 2018, we established a cohort of 848 VPT infants and their parents from 60 English neonatal units. The study population (median (IQR), gestation: 28.9 (26–30) weeks; birth weight: 1120 (886–1420) g) represented 18.9% of eligible infants born at the study sites during the recruitment period (n=4491). From the subset of 521 complete family trios, we successfully completed genotyping for 510 (97.9%) trios. Of the original 883 infants whose parents consented to participate, the parents of 796 (90.1%) infants agreed to future data linkage and 794 (89.9%) agreed to be recalled.
Conclusion We demonstrate the feasibility and acceptability of streamlined strategies for genetic, neonatal and longitudinal data collection and provide a template for future cost-effective and efficient cohort development.
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Contributors NM and AT conceptualised this study; NM, AT and MCO'D designed the study; AT, MCO'D, NM and HSW obtained funding. HSW and LH acquired and analysed the data. HSW wrote the first draft of the manuscript. All authors contributed to the editing of the manuscript and have approved the final manuscript.
Funding This study was funded by the Medical Research Council, UK (reference MR/N025288/1).
Competing interests NM reports grants from the Medical Research Council, National Institute of Health Research, Department of Health, Westminster Research Fund, Prolacta LIfe Sciences, Chiesi Pharmaceuticals, grants from Shire Pharmaceuticals, HCA International, Healthcare Quality Improvement Partnership, March of Dimes. NM is director of the Neonatal Data Analysis Unit, chief investigator for the National Neonatal Research Database, and coinvestigator for the Department of Health Funded Maternal and Neonatal Health and Care Policy Research Unit at the University of Oxford. In the last three years, NM has served on the Nestle Scientific Advisory Board and the Boards of Trustees of the Royal College of Paediatrics and Child Health, David Harvey Trust, Medical Women’s Federation, Medact, Action Cerebral Palsy and TheirWorld.
Patient consent for publication Not required.
Ethics approval This study was reviewed and approved by the Health Research Authority and the National Health Service Research Ethics Committee (reference 16/WA/0324).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data sharing not applicable as no datasets generated and/or analysed for this study.
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