Barriers and Facilitators in Clinical Trial Enrollment and Assessments of Infants Born Extremely Preterm During the COVID-19 Pandemic

ABSTRACT

Background and Objective(s) Although the overall rates of preterm birth decreased, the proportion of infants born preterm was high among Black, Indigenous, and other People of Color (BIPOC) during the COVID pandemic. This study aims to identify barriers/facilitators to study enrollment and assessment completion. Study Design: Cohort study. Study Participants & Setting: Fifty-seven very preterm infants (<29 weeks gestation) enrolled in the Supporting Play, Exploration, and Early Development Intervention trial while in a participating Neonatal Intensive Care Unit (NICU). Comparisons of two time periods for enrollment and 2 for assessments were compared;pre-COVID (Before 03/12/20), COVID (03/13/20 -03/ 12/21), and late-COVID (after 03/12/21). Materials/Methods: The proportion of eligible infants that enrolled and completed planned assessment visit was extracted from detailed enrollment and visit completion notes. A combination of assessments including the General Movement Assessment, Test of Infant Motor Performance (TIMP), Bayley Scales of Infant and Toddler Development 3rd edition (BSID), Gross Motor Function Measure (GMFM), Hammersmith Infant Neurological Exam (HINE), 5-minute observation of Parent-child interaction, and Assessment of Problem Solving in Play (APSP) were completed based on age at 5 visits over 24 months. The GMFM, APSP, and the parent child observations were completed via telemedicine (after contactless drop off of manipulatives to the family). The assessment protocols were modified to facilitate completion of as much of the assessment as possible via telemedicine. During the end of the COVID period hybrid visits, with only the BSID completed in person were included if the in-person contact was less than 60 minutes. All analysis are descriptive due to small samples. Result(s) Eligibility and enrollment was impacted by COVID with 48% and 60% of eligible infants enrolling pre-COVID decreasing to 33% and 46% during COVID. The proportion of infant that enrolled who were non-White changed, decreasing from 70 to 60% in an urban hospital and increasing from 12 to 20% in a rural hospital. The rate of in-person assessments during COVID (59%) was lower than pre-COVID (100%) or late-COVID (96%) period. Conclusions/Significance: Caregiver engagement while in the NICU and persistent study coordinators making multiple phone calls to provide ample opportunities for enrollment helps to maintain a high level of enrollment during the COVID periods. NICU visitation restrictions, children at home, and role of essential workers, who are more likely to be BIPOC, may have impacted enrollment. Quick adaptation of assessors to telehealth via training sessions and standardized protocols were identified as facilitators to enrollment and assessment completion. The GMA, APSP, Parent child observation and GMFM were performed in person as well as through telehealth with additional planning and parent engagement required. Whereas BSID, TIMP, and HINE could be performed only in-person resulting in missing data. The impact of the pandemic on research is important to understand.