Comparative efficacy and safety of late surfactant preparations: a retrospective study

Journal of Perinatology November 2021

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Lane MD, Kishnani S, Udemadu O, Danquah SE, Treadway RM, Langman A, Balevic S, Jackson WM, Laughon M, Hornik CP, Greenberg RG, Clark RH, Zimmerman KO

This study sought to characterize the use, efficacy, and safety of poractant alfa and calfactant surfactants compared to beractant in preterm infants receiving late surfactant. Compared to beractant, there is no evidence of overall superior efficacy or safety of poractant alfa.

Surfactant Administration in Preterm Infants: Drug Development Opportunities

The Journal of Pediatrics May 2019

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Taylor G, Jackson W, Hornik CP, Koss A, Mantena S, Homsley K, Gattis B, Kudumu-Clavell M, Clark R, Smith PB, Laughon MM

This study evaluated how frequently surfactant is used off-label in preterm infants. 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.

Comparative effectiveness of 3 surfactant preparations in premature infants

Journal of Pediatrics • October 2013

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Trembath A, Hornik CP, Clark R, Smith PB, Daniels J, Laughon M; Best Pharmaceuticals for Children Act—Pediatric Trials Network.

To compare effectiveness of 3 surfactant preparations (beractant, calfactant, and poractant alfa) in premature infants for preventing 3 outcomes: (1) air leak syndromes; (2) death; and (3) bronchopulmonary dysplasia (BPD) or death (composite outcome).