Cumulative number of parents of eligible infants not approached for consent in the Pre-COVID-19 epoch (baseline); COVID-1 epoch; COVID-2 epoch; Post-COVID -1 epoch; and Post-COVID-2.
The red line represents the cumulative number of parents not approached for any reason, and the blue line represents parents not approached due directly to COVID-19-related restrictions on clinical research. These site-specific restrictions gradually abated in COVID-2 and were not a factor in Post-COVID epochs. The cumulative number of all families not approached for any reason has continued to increase even in the two Post-COVID epochs, as the percent of families of eligible infants approached for consent has still not fully recovered.