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Comparative effectiveness of surfactant preparations in premature infants
Andrea Trembath1, Christoph P Hornik, Reese Clark
1Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.
Insights
Three surfactant preparations, beractant, calfactant, and poractant alfa, showed similar effectiveness in preventing air leak syndromes, death, and bronchopulmonary dysplasia or death in premature infants. Site variations may explain previously observed differences in mortality.
Area of Science:
- Neonatology
- Pulmonology
- Pharmacology
Background:
- Premature infants often require surfactant replacement therapy to manage respiratory distress syndrome.
- Different surfactant preparations, including beractant, calfactant, and poractant alfa, are available, with varying clinical use and reported outcomes.
- Comparative effectiveness data are crucial for guiding therapeutic choices in neonatal intensive care.
Purpose of the Study:
- To compare the effectiveness of beractant, calfactant, and poractant alfa in premature infants.
- To evaluate the prevention of air leak syndromes, death, and a composite of bronchopulmonary dysplasia (BPD) or death.
- To identify potential differences in outcomes among these surfactant preparations.
Main Methods:
- A comparative effectiveness study involving premature infants from 322 US neonatal intensive care units (2005-2010).
- Treatment groups included beractant, calfactant, and poractant alfa.
- Outcomes (air leak syndromes, death, BPD or death) were compared using adjusted analyses considering gestational age, antenatal steroids, discharge year, and small for gestational age status.
Main Results:
- A total of 51,282 infants received surfactant: 40% beractant, 30% calfactant, 30% poractant alfa.
- Adjusted analyses revealed similar risks for air leak syndromes across all three surfactant groups.
- No significant differences were observed in the risk of death or the composite outcome of BPD or death among the surfactant preparations.
Conclusions:
- Beractant, calfactant, and poractant alfa demonstrate comparable effectiveness in preventing key adverse outcomes in premature infants.
- Observed differences in mortality between surfactants may be attributed to variations in clinical practice or site-specific factors rather than inherent effectiveness.
- These findings support the use of any of these three surfactant preparations with similar expectations for preventing major respiratory complications.
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 51282 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.
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