Surfactant Administration in Preterm Infants: Drug Development Opportunities - 24/04/19
, Wesley Jackson, MD, MPH 1, Christoph P. Hornik, MD, MPH 2, 3, Alec Koss 2, Sreekar Mantena 2, Kenya Homsley 2, Blair Gattis 2, Menefese Kudumu-Clavell 2, Reese Clark, MD 4, P. Brian Smith, MD, MPH, MHS 2, 3, Matthew M. Laughon, MD, MPH 1Abstract |
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.
Le texte complet de cet article est disponible en PDF.Keywords : surfactant, drug development
Abbreviations : BPD, CPAP, FDA, GA, INSURE, NICU, RDS
Plan
| Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Contracts HHSN267200700051C and HHSN275201000003I), the US Food and Drug Administration Office of Orphan Product Development (R01 FD005101), the National Heart, Lung, and Blood Institute (R34 HL124038), the National Center for Advancing Translational Sciences (UL1TR001117), and the National Institutes of Health (NIH-1R21HD080606-01A1). The sponsors had no role in study design and conduct; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. The authors declare no conflicts of interest. |
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| Portions of this study were presented at the Pediatric Academic Societies annual meeting, May 6-9, 2017, San Francisco, California. |
Vol 208
P. 163-168 - mai 2019 Retour au numéro
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