Surfactant Administration in Preterm Infants: Drug Development Opportunities.

OBJECTIVE: To evaluate how frequently surfactant is used off-label in preterm infants. STUDY DESIGN: We conducted a retrospective cohort analysis of prospectively collected administrative data for 2005-2015 from 348 neonatal intensive care units in the US. We quantified off-label administration of poractant alfa, calfactant, or beractant in inborn infants born at <37 weeks of gestational age (GA). Off-label surfactant administration was defined according to the Food and Drug Administration (FDA) label. RESULTS: Of a total of 110 822 preterm infants who received surfactant, 68 226 (62%) received the surfactant off-label. The majority of infants who received surfactant off-label had a higher birth weight than those who received surfactant on-label (40 716 [37%]), had an older GA than those who received surfactant on-label (35 191 [32%]), or were treated with intubation and surfactant administration followed by immediate extubation (INSURE) (32 310 [29%]). Poractant alfa was administered via INSURE more frequently than beractant or calfactant (16 688 [38%], 7137 [20%], and 8485 [27%], respectively). An increasing number of infants received surfactant via INSURE from 2005 to 2015 (from 1697 [19%] to 3368 [36%]). CONCLUSIONS: The majority of surfactant given to preterm infants is administered off-label. The uptrend in administration via INSURE coincides with increased supporting evidence. The gap between FDA labeling and current clinic practice exemplifies an opportunity for label expansion, which may require additional prospective or retrospective safety and/or effectiveness data for infants of older GA and higher birth weight.

A pilot study: the impact of clinic-provided transportation on missed clinic visits and system costs among teenage mother-child dyads.

Transportation insecurity has profound impacts on the health and wellbeing of teenage parents and their children, who are at particularly high risk for missed clinic visits. In other settings, clinic-offered rideshare interventions have reduced the rates of missed visits. We conducted a one-arm pre-post time series analysis of missed visits before and after a pilot study rideshare intervention within a clinic specializing in the care of teenage parents and their children. We compared the number of missed visits during the study with the number during the preceding year (July 2019-March 2020), as well as the cost difference of missed visits, adjusting for inflation and clinic census. Of 153 rides scheduled, 106 (69.3%) were completed. Twenty-nine (29.9%) of 97 clinic visits were missed during the study period, compared to 145 (32.7%) of 443 comparison period visits (p-value = 0.59). The estimated cost difference of missed visits including intervention costs was a net savings of $90,830.32. However, the standardized cost difference was a net excess of $6.90 per clinic visit. We found no difference in rates of missed visits or costs, though likely impacted by the low census during the SARS-CoV-2 pandemic. Given the potential to improve health disparities exacerbated by the pandemic, further research is warranted into the impact and utility of clinic-offered rideshare interventions.