Impact of COVID-19 on Pediatric Clinical Research

Abstract

Purpose: Many public institutions and settings have taken action to limit exposure to and slow the spread of the novel coronavirus (COVID-19). We sought to characterize the impact of stay-at-home orders on our study of cerebral autoregulation and its association with developmental delays in infants with congenital heart disease compared with healthy controls.

Design and methods: We calculated the number of participants recruited (i.e., not enrolled in the study) and assessed (i.e., currently enrolled) before March 2020 (pre-COVID-19) and the number of participants that we could not recruit or assess between March and July 2020 (missed due to COVID-19), separately for congenital heart disease and healthy control infants, in reference to the impacts of COVID-19. We used negative binomial regressions to determine incidence rate ratios which compared participants recruited and assessed pre-COVID-19 and missed due to COVID-19.

Results: Recruitment and assessments significantly decreased following the pandemic, i.e., participants were more likely to be recruited or be assessed pre-COVID-19 compared to during the pandemic. Study participants were 3.3 times as likely to have assessments performed pre-COVID-19 compared to during the COVID-19 pandemic (p < 0.001).

Clinical implications: Clinical research teams may consider making protocol modifications such as virtual visits or video recordings explaining the study, for example, to adjust to the restrictions caused by COVID-19.

Conclusion: The COVID-19 pandemic drastically reduced recruitment and assessments completed in our study. Study teams will need to continue to modify procedures for recruitment and assessments that align with COVID-19 regulations to facilitate research progress during the pandemic.

Keywords: COVID-19; Clinical research; Congenital heart disease; Pediatrics; Stay-at-home order.