Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies.

This was a descriptive analysis of trial engagement, not a test of whether the intervention changed infant outcomes. The sample was 63 infants from one clinical trial, so the patterns may not apply to other settings. There was no a priori sample size or analysis plan, and the pandemic periods were not equal length. The late-pandemic period was shortened because of the Omicron surge. The paper used descriptive statistics rather than statistical tests to compare periods. The intervention analysis included only 26 infants after exclusions and withdrawals, and 7 infants were still receiving intervention at the time of analysis. Parent survey response was very low: 5 of 41 parents responded in peak pandemic and 11 of 47 parents responded in late pandemic. The sample was primarily non-Hispanic and required parents to read and speak English, so it may not apply to other language or ethnic groups. Black infant enrollment dropped during peak pandemic, but the paper does not show why. In-person-only outcome measures were missed, so later trial outcome data may be incomplete.

The authors declare no conflicts of interest. The study described was supported by NICHD R01HD093624.

Do not conclude that telehealth fully replaced the study's in-person work. During the peak-pandemic period, 36 outcome measures that required in-person administration were missed, and completion of in-person-only measures declined.