Comparative Effectiveness of Surfactant Preparations in Premature Infants - 24/09/13
, Julie Daniels, PhD, MPH 5, Matthew Laughon, MD, MPH 6Best Pharmaceuticals for Children Act—Pediatric Trials Network∗
Abstract |
Objective |
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).
Study design |
We conducted a comparative effectiveness study of premature infants admitted to 322 neonatal intensive care units in the US from 2005-2010 who were treated with beractant, calfactant, or poractant alfa. We compared the incidence of air leak syndromes, death, and BPD or death, adjusting for gestational age (GA), antenatal steroids, discharge year, and small for GA status.
Results |
A total of 51 282 infants received surfactant; 40% received beractant, 30% calfactant, and 30% poractant alfa. Median birth weight was 1435 g (IQR 966-2065); median GA was 30 weeks (27-33). On adjusted analysis, we observed a similar risk of air leak syndromes (calfactant vs beractant OR = 1.17 [95% CI: 0.95, 1.43]; calfactant vs poractant OR = 1.23 [0.98, 1.56]; beractant vs poractant OR = 1.06 [0.87, 1.29]), death (calfactant vs beractant OR = 1.14 [0.93, 1.39]; calfactant vs poractant OR = 0.98 [0.78, 1.23]; beractant vs poractant OR = 0.86 [0.72, 1.04]), and BPD or death (calfactant vs beractant OR = 1.08 [0.93, 1.26]; calfactant vs poractant OR = 1.19 [1.00, 1.41]; beractant vs poractant OR = 1.10 [0.96, 1.27]).
Conclusions |
Beractant, calfactant, and poractant alfa demonstrated similar effectiveness in prevention of air leak syndromes, death, and BPD or death in premature infants when adjusted for site. Previously described differences in mortality between surfactants likely do not represent true differences in effectiveness but may relate to site variation in outcomes.
Le texte complet de cet article est disponible en PDF.Keyword : BPD, GA, NICU, RDS
Plan
| Supported by the American Recovery and Reinvestment Act (DHHS-1R18AE000028-01 to P.S.). M.L. receives salary support for research in pediatric and neonatal clinical pharmacology from the US government (HHSN267200700051C, principal investigator Benjamin, under the Best Pharmaceuticals for Children Act) and National Institutes of Child Health and Human Development (NICHD; 1K23HL092225-01). P.S. receives salary support for research from the National Institutes of Health (HHSN267200700051C),US Department of Health and Human Services (DHHS-1R18AE000028-01), and NICHD (1K23HD060040-01). R.C. is an employee of the Pediatrix Center for Research and Education. The other authors declare no conflicts of interest. |
Vol 163 - N° 4
P. 955 - octobre 2013 Retour au numéro
Article précédent
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