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Abstract
Objective To describe strategies used to maximise follow-up after a neonatal randomised trial, how these differed for families of different ethnicity, socioeconomic status and urban versus rural residence and investigate relationships between the difficulty of follow-up and rate of neurosensory impairment.
Method hPOD was a multicentre randomised trial assessing oral dextrose gel prophylaxis for neonatal hypoglycaemia. Follow-up at 2 years was conducted from 2017 to 2021. We analysed all recorded contacts between the research team and participants’ families. Neurosensory impairment was defined as blindness, deafness, cerebral palsy, developmental delay or executive function impairment.
Results Of 1321 eligible participants, 1197 were assessed (91%) and 236/1194 (19.8%) had neurosensory impairment. Participants received a median of five contacts from the research team (range 1–23). Those from more deprived areas and specific ethnicities received more contacts, particularly home tracking visits and home assessments. Impairment was more common among participants receiving more contacts (relative risk 1.81, 95% CI 1.34 to 2.44 for ≥7 contacts vs <7 contacts), and among those assessed after the intended age (76/318, 23.9% if >25 months vs 160/876, 18.3% if ≤25 months).
Conclusions Varied contact strategies and long timeframes are required to achieve a high follow-up rate. Without these, the sociodemographics of children assessed would not have been representative of the entire cohort, and the rate of neurosensory impairment would have been underestimated. To maximise follow-up after randomised trials, substantial effort and resources are needed to ensure that data are useful for clinical decision-making.
- child development
- neonatology
- healthcare disparities
- follow-up studies
Data availability statement
Data are available on reasonable request.
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Data availability statement
Data are available on reasonable request.
Footnotes
Collaborators Members of the hPOD Follow-Up Group: Jane E Harding, Jane M Alsweiler, Caroline A Crowther, Richard P Edlin, Taygen Edwards, Gregory D Gamble, Joanne E Hegarty, Luling Lin, Christopher JD McKinlay, Jenny Rogers, Benjamin Thompson, Trecia Wouldes
Contributors LL and JEH formulated the plan for this secondary analysis. JR and LL collected data. LL, GDG and JEH were responsible for data analysis and interpretation. LL drafted the initial manuscript and all authors contributed to critical revisions and approved the manuscript. JEH is guarantor.
Funding The hPOD Trial was funded by a grant from the Health Research Council of New Zealand (13/131). The hPOD 2-year follow up was funded by grants from the Health Research Council of New Zealand (grant 15/216) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH; grant R01HD091075). This secondary analysis was funded by the Aotearoa Foundation (9909494).
Disclaimer The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript and decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NICHD or the NIH.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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