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Meta-Analysis
. 2019 Feb 6;20(1):28.
doi: 10.1186/s12931-019-0979-0.

Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes

Affiliations
Meta-Analysis

Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes

Ascanio Tridente et al. Respir Res. .

Abstract

Background: Bovine surfactants are known to be clinically equivalent but it is unclear if porcine or bovine surfactants at their licensed dose should be preferred to treat respiratory distress syndrome in preterm neonates.

Methods: We performed a comprehensive review of biochemical and pharmacological features of surfactants to understand the biological plausibility of any clinical effect. We then performed a pragmatic meta-analysis comparing internationally marketed porcine and bovine surfactants for mortality and respiratory outcomes. Search for randomised controlled trials with no language/year restrictions and excluding "grey" literature, unpublished or non-peer reviewed reports was conducted, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the most recent methodological recommendations.

Results: Sixteen articles were included in the review and 14 in the meta-analysis (1491 neonates). 200 mg/kg poractant-α (a porcine surfactant) was associated with lower BPD/mortality (OR 0.632[95%CI:0.494, 0.809];p < 0.001),BPD (OR 0.688[95%CI:0.512, 0.925];p = 0.013), retreatment (OR 0.313[95%CI:0.187, 0.522];p < 0.0001), airleaks (OR 0.505[95%CI:0.308, 0.827];p = 0.006) and lung haemorrhage (OR 0.624[95%CI:0.388, 1];p = 0.051). Gestational age is associated with effect size for BPD (coefficient: 0.308 [95%CI:0.063, 0.554];p = 0.014) and surfactant retreatment (coefficient: -0.311 [95%CI:-0.595, - 0.028];p = 0.031).

Conclusion: 200 mg/kg poractant-α is associated with better respiratory outcomes compared to bovine surfactants at their licensed dose. The effect of poractant-α on BPD and surfactant retreatment is greater at lowest and highest gestational ages, respectively.

Trial registration: PROSPERO n.42017075251 .

Keywords: Neonate; RDS; Surfactant; Therapy.

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Conflict of interest statement

Ethics approval

Not applicable as this is a review and meta-analysis. Trials meta-analysed have all received their original ethical approval.

Consent for publication

Not applicable

Competing interests

A/Prof. D. De Luca has received grants for research and educational projects from Chiesi Pharmaceuticals spa and ABBVIE inc. He also received travel grants from ABBVIE inc. He served as consultant and lecturer for both Chiesi Pharmaceuticals spa and ABBVIE inc. Finally, he has been member of the external advisory board for both Chiesi Pharmaceuticals spa and ABBVIE inc. These companies produce two surfactants analysed in the paper, but they had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, approval of the manuscript or decision to submit it for publication. The other authors declare no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the review. The studies excluded from the systematic review were two full text duplicates [24, 25] reporting the same data with major methodological flaws (lack of randomization, unclear analysis, lack of allocation concealment and blinding, unclear sample size calculation, unclear outcome definition and incomplete outcome analysis/reporting) and one abstract which did not respect the eligibility criteria [22]. Two studies [42, 43] included in the systematic review were excluded from the meta-analysis because they investigated the use of non-internationally available porcine surfactants
Fig. 2
Fig. 2
Comparisons poractant-α vs bovine surfactants for mortality (c-b) and for the composite outcome BPD/mortality (c-d). Panels a-c illustrate meta-analyses of 200 mg/kg poractant-α vs bovine surfactants (1193 patients); panels b (1482 patients) and d (1370 patients) illustrate meta-analyses of any dose of poractant-α vs bovine surfactants. Poractant-α and bovine surfactants are considered as treatment (Trt) and control (Ctrl) arm, respectively; events per arm and odds ratio (95%CI) are reported. All analyses have been performed with random effect model
Fig. 3
Fig. 3
Comparisons poractant-α vs bovine surfactants for BPD (a-b) and surfactant redosing (c-d). Panels a (1193 patients) and c (1164 patients) illustrate meta-analyses of 200 mg/kg poractant-α vs bovine surfactants; panels b (1370 patients) and d (1372 patients) illustrate meta-analyses of any dose of poractant-α vs bovine surfactants. Poractant-α and bovine surfactants are considered as treatment (Trt) and control (Ctrl) arm, respectively; events per arm and odds ratio (95%CI) are reported. All analyses have been performed with random effect model
Fig. 4
Fig. 4
Comparisons poractant-α vs bovine surfactants for airleaks (a-b) and lung haemorrhage (c-d). Panels a (1154 patients) and c (1034 patients) illustrate meta-analyses of 200 mg/kg poractant-α vs bovine surfactants; panels b (1442 patients) and d (1242 patients) illustrate meta-analyses of any dose of poractant-α vs bovine surfactants. Poractant-α and bovine surfactants are considered as treatment (Trt) and control (Ctrl) arm, respectively; events per arm and odds ratio (95%CI) are reported. All analyses have been performed with random effect model
Fig. 5
Fig. 5
Meta-regressions plots. Gestational age (GA) – response relationships for the incidence of bronchopulmonary dysplasia (Panel a; the lower the gestational age, the lower the odds) and the need for surfactant retreatment (Panel b; the higher the gestational age, the lower the odds) are shown. Gestational age is expressed in weeks

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