Medical Student University of Missouri-Kansas City School of Medicine Kansas City, Missouri, United States
Background: The COVID-19 pandemic introduced barriers to conducting biomedical research due to changes in care practices, limited access for routine medical care, and restricted access to patients for research. However, the impact of COVID-19 on neonatal research is not known. Objective: To describe the impact of COVID-19 pandemic on registered neonatal clinical studies and the reasons for study discontinuation pre- and post-pandemic. Design/Methods: In this study, we will quantify the baseline activity of active neonatal research studies pre-pandemic and track changes after the onset of the COVID-19 pandemic.
We conducted a systematic search utilizing ClinicalTrials.gov to identify studies involving infants admitted to the neonatal intensive care unit (NICU). We queried the site on July 1, 2023, with search date ranging from January 1, 2018 through December 31, 2022. The search included studies with the following statuses: “recruiting”, “active, not recruiting”, “completed”, “terminated”, “enrolling by invitation”, “suspended”, and “withdrawn” and ages of 0-1 year. We have identified 4,818 potential studies for further evaluation.
All resulting studies were screened to identify those involving NICU-admitted patients. In cases of uncertainty, two neonatologists (KA, SG) evaluated for study inclusion. We will extract data on current trial status, condition treated, funding, study type, enrollment, trial location and, if indicated, the reason for study discontinuation.
The final study cohort will be analyzed in multiple ways. Temporally, we will evaluate three time periods: pre-COVID (2018-2019), early COVID (2020) and late COVID (2021-2022). We will assess the number of active studies and rates of study closure over time periods. We will further evaluate the evolving reasons for study discontinuation, including COVID-19 and low enrollment. We will also compare neonatal studies discontinued due to COVID-19 versus other reasons and evaluate for pertinent associations.
Analysis of these focused studies will determine impact of their progression with reference to COVID-19.
