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Impact of COVID-19 on Pediatric Clinical Research

Nhu N Tran1, Michelle Tran2, Jeraldine Lopez3

  • 1Keck School of Medicine of University of Southern California (KSOM USC), Department of Surgery and Children's Hospital, Los Angeles (CHLA), United States of America.

Journal of Pediatric Nursing
|June 25, 2021
PubMed

Insights

The COVID-19 pandemic significantly reduced participant recruitment and assessments for studies on infant cerebral autoregulation. Researchers must adapt study protocols to navigate pandemic-related restrictions and ensure research continuity.

Area of Science:

  • Pediatric Cardiology
  • Neurodevelopmental Pediatrics
  • Infectious Disease Epidemiology

Background:

  • Public health measures, including stay-at-home orders, were implemented globally to mitigate COVID-19 transmission.
  • Understanding the impact of these measures on ongoing clinical research is crucial for maintaining scientific progress.
  • Cerebral autoregulation is vital for brain development, particularly in infants with congenital heart disease (CHD).

Purpose of the Study:

  • To evaluate the effect of COVID-19 stay-at-home orders on a study investigating cerebral autoregulation and developmental delays in infants with CHD.
  • To compare recruitment and assessment rates in infants with CHD and healthy controls before and during the COVID-19 pandemic.

Main Methods:

  • A retrospective analysis was conducted comparing participant recruitment and assessment numbers before (pre-COVID-19) and during (March-July 2020) the pandemic.
  • Data were stratified for infants with CHD and healthy controls.
  • Negative binomial regressions were used to calculate incidence rate ratios comparing pre-COVID-19 and during-COVID-19 periods.

Main Results:

  • A significant decrease in both recruitment and assessments was observed during the COVID-19 pandemic.
  • Infants were 3.3 times more likely to have assessments completed pre-COVID-19 compared to during the pandemic (p < 0.001).
  • This decline impacted both CHD and healthy control groups.

Conclusions:

  • The COVID-19 pandemic substantially hindered participant recruitment and data collection in this study.
  • Clinical research teams should consider protocol modifications, such as implementing virtual visits or remote data collection methods, to adapt to pandemic restrictions.
  • Adapting research procedures is essential for sustaining research momentum during public health crises.
Abstract

Keywords:
COVID-19Clinical researchCongenital heart diseasePediatricsStay-at-home order

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