Barriers to Recruitment in an Acute Neonatal Seizure Drug Trial: Lessons From a Randomized, Double-Blind, Controlled Study of Intravenous Phenobarbital

Background

Despite the prevalence of seizures among neonates, neonatal seizure drug trials are rarely conducted due to ethical considerations, difficulties in trial design, and limited hospital resources and personnel. The purpose of this prospective consecutive case series is to highlight the experiences and challenges encountered by a single study site in participant recruitment for an acute neonatal seizure treatment trial that was active between January 24, 2022, and February 1, 2023.

Methods

Outcomes include information about each screened patient's trial recruitment process, namely, the patient's time of admission, eligibility status, reasons why potentially eligible patients were not approached, reasons consent was declined, and seizure outcomes.

Results

The study team screened 164 of 191 (86%) patients transferred to the Children's National Hospital neonatal intensive care unit for continuous electroencephalography. Of the 164 patients screened, 71 (43%) were ineligible for the study, and consent was not attempted on an additional 69 (42%) patients. A total of 24 patients were approached for consent, and 12 (50%) declined. Only two (17%) patients were treated with the study drug, as the remaining 10 (83%) enrolled patients failed the screening. Sixteen of the unscreened or nonconsenting patients went on to have seizures within the study period and would have been eligible to receive the study drug if enrolled.

Conclusions

Poor recruitment in acute neonatal seizure treatment trials may be improved by addressing issues in the consent process, personnel and resource allocation, and parent suspicion about clinical trials.