Cumulative numbers of infants eligible for enrollment and families of eligible infants approached for consent in the Pre-COVID-19 baseline epoch; COVID-1 epoch; COVID-2 epoch; Post-COVID -1 epoch; and Post-COVID-2.
The blue line represents the cumulative increase in the number of infants eligible for enrollment, and the green line represents the cumulative number of parents of eligible infants approached for consent. In the Pre-COVID epoch, 95.4% of parents of eligible infants were approached for consent. From the nadir in COVID-1, the cumulative number of parents of eligible infants approached progressively improved in the subsequent epochs, but only to 84.9% in Post-COVID-2 (The COVID-1 epoch saw a dramatic increase in number of eligible families not approached due to clinical site-imposed restrictions on research (Fig. 