Beractant 200mg/8ml endotracheopulmonary suspension bottles

ObjectiveAmong the mechanisms proposed for the development of bronchopulmonary dysplasia is the increase in the pulmonary inflammatory process and oxidative stress. Thus, the control of this process may result in improvements in bronchopulmonary dysplasia-related outcomes. This study aims to analyze the current scientific evidence regarding the use of budesonide, a potent anti-inflammatory drug, associated with a pulmonary surfactant to prevent bronchopulmonary dysplasia.MethodsA systematic review of the literature was performed on the Embase and MEDLINE platforms, and studies that compared budesonide with pulmonary surfactant versus pulmonary surfactant for treating respiratory distress syndrome were included. The primary outcome was a reduction in bronchopulmonary dysplasia or death.ResultsFour randomized clinical trials and two observational studies were included in this systematic review. Three of the randomized clinical trials found a reduction in bronchopulmonary dysplasia or death in the use of budesonide with the surfactant, all the other studies (1 clinical trial and 2 observational studies) found no statistical differences between the groups for the primary outcomes. The three main studies showed a reduction in the primary outcome; however, all studies showed great heterogeneity regarding the type of surfactant (poractant or beractant) and the method of administration.ConclusionRobust clinical studies, in a heterogeneous population, using porcine surfactant associated with budesonide, with administration by a minimally invasive technique are necessary for there to be a recommendation based on scientific evidence for its widespread use.

Abstract licence: CC BY

AbstractFindings from previous meta-analyses of randomized clinical trials (RCTs) in premature infants with respiratory distress syndrome (RDS) varied as to whether clinical outcomes differed by type of animal-derived pulmonary surfactant; real-world evidence (RWE) was excluded. We extracted study characteristics and outcomes from full-text articles from a systematic search for studies that compared beractant with poractant alfa for RDS in preterm infants. RWE data were tabulated; RCT data were subjected to meta-analyses. Designs, patient characteristics, and follow-up durations varied widely among studies (4 RWE, 15 RCT). RWE studies with adjusted odds ratios (ORs) found no statistically significant between-treatment differences in outcomes. In RCT meta-analyses, no statistically significant between-treatment differences were observed for death (OR [95% confidence interval], 1.35 [0.98–1.86]), bronchopulmonary dysplasia (1.25 [0.96–1.62]), pneumothorax (1.21 [0.72–2.05]), and air leak syndrome (2.28 [0.82–6.39]). Collectively, outcomes were similar with beractant and poractant alfa in RWE studies and pooled RCTs.

Abstract licence: CC BY 4.0

Randomized controlled trial (RCT) data are analyzed by two challengeable adjusted and non-adjusted approaches. Performing appropriate adjusted analysis leads to a more interpretable and efficient estimation of treatment effects. Semiparametric adjustment approach modifies the estimating equations solved by the marginal treatment effect estimator by adding an augmentation function, which makes use of the baseline covariates and estimate the unbiased marginal treatment effect with improved precision. The effect of the intervention obtained using the semi-parametric adjustment method, similar to the unadjusted method and contrary to the adjusted parametric method, is marginal, resulting in better interpretability. Moreover, due to leveraging baseline covariates, it is more efficient compared to the unadjusted models. This study aimed to estimate the effect of beractant (Beraksurf™, Tekzima Company), compared with the Poractant alfa (Curosurf®, Chiesi Pharmaceuticals), as surfactant replacement therapy, on the need for Intermittent Positive Pressure Ventilation (IPPV) in Neonatal Respiratory Distress Syndrome (NRDS) more precisely by fitting a semi-parametric efficient model adjusted for appropriate covariates. This study is secondary and we re-analyzing data of a published RCT. This RCT was conducted in the NICU of Alzahra Hospital in Tabriz, Iran for eight months, and 200 infants were assigned to two groups receiving either 100 mg/kg BeraksurfTM (n = 99) or 200 mg/kg Curosurf® (n = 101). The effect of the treatments was evaluated regarding the need for IPPV by fitting semi-parametric logistic regression models, adjusted for the best subset of covariates selected by the forward variable selection algorithm and confounders identified by the expert panel. IPPV in our study was administered via an endotracheal tube, as per the protocol followed in the primary trial. The need for IPPV was determined based on the clinical judgment of neonatologists, considering the infants' respiratory distress levels, oxygen saturation, and arterial blood gas measurements. The decision was made within the first 72 h after surfactant administration. The proportions of the required IPPV outcome were 29.3% and 59.4% in the BeraksurfTM group and Curosurf®, respectively. While the unadjusted comparison between the two treatments was significant (OR = .283, 95% CI: (.157, .509), P-value < .001), adjusted OR in semi-parametric logistic regression by adjusting for the best subset of covariates selected by forward method including steroids, Apgar score at min1, and initial Fio2 wasn’t significant (OR = .751, 95% CI: (.510, 1.111), P-value = .151). The efficacy of this semi-parametric model over the unadjusted model was 1.81. The results of the expert-based adjusted model, adjusting for the gestational age, birth weight, and initial FiO2, were consistent with those derived from the R2-based selection, supporting the robustness of our findings (OR = .685, 95% CI: (.449, 1.529), P-value = .078). Fitting a semi-parametric model adjusted for the baseline covariates resulted in a marginal, unbiased, more efficient and interpretable estimation of BeraksurfTM versus Curosurf® effects. Although the crude model showed that BeraksurfTM was more effective than Curosurf®, the results of the efficient semi-parametric model with adjustment for the best subset of covariates revealed no statistically significant difference between the two drugs regarding their effects. We hope that the use of this method and its findings will contribute to a better understanding of covariate adjustment.

Abstract licence: CC BY-NC-ND 4.0

Abstract Objective: Exogenous surfactant therapy is vital in managing respiratory distress syndrome (RDS) in preterm infants, with less invasive surfactant administration (LISA) gaining popularity. This study aimed to assess the efficacy and short-term outcomes of LISA using beractant and poractant alfa. Study Design: In a randomized controlled trial , we enrolled preterm infants (28-33+6 weeks) with RDS requiring surfactant. LISA was employed, with beractant at 100 mg/kg or poractant-alfa at 200 mg/kg. Primary outcome was the need for intubation within 72 hours. Results: Among 120 infants, 3.3% in both groups required intubation within 72 hours (p value 1.00, 95% CI 0.14 - 6.86). No significant differences in secondary outcomes were noted, except a trend towards increased necrotizing enterocolitis with beractant . Beractant was significantly more economical. Conclusion: Beractant and poractant-alfa exhibit similar efficacy in LISA for preterm infants with RDS. Economic considerations, especially in LMICs, favour beractant. The trial is registered in the clinical trial registry of India (CTRI/2023/03/050375).

Abstract licence: CC BY 4.0