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Surfactant Administration in Preterm Infants: Drug Development Opportunities
Genevieve Taylor1, Wesley Jackson1, Christoph P Hornik2
1Department of Pediatrics, The University of North Carolina, Chapel Hill, NC.
The Journal of Pediatrics
|December 25, 2018
Summary
Most surfactant use in preterm infants is off-label, particularly for those with higher birth weights or gestational ages. The increasing use of the INSURE method highlights a need for updated FDA labeling.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Pediatric Critical Care
Background:
- Surfactant therapy is crucial for respiratory distress syndrome in preterm infants.
- Current Food and Drug Administration (FDA) labeling may not reflect evolving clinical practices.
- Off-label use of medications is common in neonatology.
Purpose of the Study:
- To determine the frequency of off-label surfactant administration in preterm infants in the US.
- To analyze patterns of off-label surfactant use based on infant characteristics and administration methods.
Main Methods:
- Retrospective cohort analysis of administrative data from 348 US neonatal intensive care units (2005-2015).
- Quantified off-label use of poractant alfa, calfactant, and beractant in infants <37 weeks gestational age.
- Defined off-label use based on FDA labeling guidelines.
Main Results:
- 62% of 110,822 preterm infants receiving surfactant were administered it off-label.
- Off-label use was more common in infants with higher birth weight and older gestational age.
- The intubation and surfactant administration followed by immediate extubation (INSURE) method increased significantly from 2005-2015.
Conclusions:
- The majority of surfactant administration in preterm infants occurs off-label.
- Increased use of the INSURE technique aligns with growing evidence supporting its efficacy.
- The discrepancy between FDA labels and clinical practice suggests a need for label expansion, potentially requiring new safety and effectiveness data.
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