A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants
Background: Neonatal respiratory distress syndrome (NRDS) affects approximately up to 7% of all term newborns. This study aimed to assess the efficacy and safety of investigational beractant (BeraksurfTM, Tekzima Company) in comparison with poractant alfa (Curosurf®, Chiesi Pharmaceuticals) as surfa...
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| Format: | Article |
| Language: | English |
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Tabriz University of Medical Sciences
2023-01-01
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| Series: | Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | https://ps.tbzmed.ac.ir/PDF/ps-29-52.pdf |
| _version_ | 1797846161214668800 |
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| author | Manizheh Mostafa Gharehbaghi Parvin Sarbakhsh Hossein Mohammadbager Safoora Gharibzadeh Elnaz Shaseb |
| author_facet | Manizheh Mostafa Gharehbaghi Parvin Sarbakhsh Hossein Mohammadbager Safoora Gharibzadeh Elnaz Shaseb |
| author_sort | Manizheh Mostafa Gharehbaghi |
| collection | DOAJ |
| description | Background: Neonatal respiratory distress syndrome (NRDS) affects approximately up to 7% of all term newborns. This study aimed to assess the efficacy and safety of investigational beractant (BeraksurfTM, Tekzima Company) in comparison with poractant alfa (Curosurf®, Chiesi Pharmaceuticals) as surfactant replacement therapy in NRDS. Methods: This trial was a randomized, controlled, single-blind, phase III study of two natural surfactants which was conducted in NICU of Alzahra hospital in Tabriz for 8 months. 220 infants were enrolled in 2 groups to receive either 100 mg/kg BeraksurfTM or 200 mg/kg Curosurf® as an initial dose endotracheally. Additional doses were given if needed. Infants’ gestational age, birth weight, discharge weight and other demographic information were recorded. Efficacy outcomes were changes in fraction of inspired oxygen (FiO2) and the number of infants who reached FiO2 less than 0.3 (treatment success rate) which were compared between both groups with analysis of covariance (ANCOVA). Results: The results showed that the treatment success rate was 92% and 72% in BeraksurfTM and Curosurf® groups, respectively (P-value< 0.001). In addition, no difference was observed in the efficacy of these two treatments in terms of binary outcomes and incidence of complications such as mortality. Conclusion: The result analysis of current study implies BeraksurfTM has same beneficial impact on clinical management of RDS as Curosurf® among infants below 32 weeks. However, larger studies are needed to evaluate further efficacy and safety outcomes of this surfactant in comparison with the reference products in other subgroups. |
| first_indexed | 2024-04-09T17:50:27Z |
| format | Article |
| id | doaj.art-71218f0f8465439c825c4a382ea2fb1b |
| institution | Directory Open Access Journal |
| issn | 2383-2886 |
| language | English |
| last_indexed | 2024-04-09T17:50:27Z |
| publishDate | 2023-01-01 |
| publisher | Tabriz University of Medical Sciences |
| record_format | Article |
| series | Pharmaceutical Sciences |
| spelling | doaj.art-71218f0f8465439c825c4a382ea2fb1b2023-04-16T08:16:43ZengTabriz University of Medical SciencesPharmaceutical Sciences2383-28862023-01-01291525810.34172/PS.2022.8ps-34658A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm InfantsManizheh Mostafa Gharehbaghi0Parvin Sarbakhsh1Hossein Mohammadbager2Safoora Gharibzadeh3Elnaz Shaseb4Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.Pasteur Institute of Iran, Tehran University of Medical Sciences, Tehran, Iran.Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.Background: Neonatal respiratory distress syndrome (NRDS) affects approximately up to 7% of all term newborns. This study aimed to assess the efficacy and safety of investigational beractant (BeraksurfTM, Tekzima Company) in comparison with poractant alfa (Curosurf®, Chiesi Pharmaceuticals) as surfactant replacement therapy in NRDS. Methods: This trial was a randomized, controlled, single-blind, phase III study of two natural surfactants which was conducted in NICU of Alzahra hospital in Tabriz for 8 months. 220 infants were enrolled in 2 groups to receive either 100 mg/kg BeraksurfTM or 200 mg/kg Curosurf® as an initial dose endotracheally. Additional doses were given if needed. Infants’ gestational age, birth weight, discharge weight and other demographic information were recorded. Efficacy outcomes were changes in fraction of inspired oxygen (FiO2) and the number of infants who reached FiO2 less than 0.3 (treatment success rate) which were compared between both groups with analysis of covariance (ANCOVA). Results: The results showed that the treatment success rate was 92% and 72% in BeraksurfTM and Curosurf® groups, respectively (P-value< 0.001). In addition, no difference was observed in the efficacy of these two treatments in terms of binary outcomes and incidence of complications such as mortality. Conclusion: The result analysis of current study implies BeraksurfTM has same beneficial impact on clinical management of RDS as Curosurf® among infants below 32 weeks. However, larger studies are needed to evaluate further efficacy and safety outcomes of this surfactant in comparison with the reference products in other subgroups.https://ps.tbzmed.ac.ir/PDF/ps-29-52.pdfberactantporactant alfarespiratory distress syndrome (rds)surfactantsurfactant replacement therapy (srt) |
| spellingShingle | Manizheh Mostafa Gharehbaghi Parvin Sarbakhsh Hossein Mohammadbager Safoora Gharibzadeh Elnaz Shaseb A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants Pharmaceutical Sciences beractant poractant alfa respiratory distress syndrome (rds) surfactant surfactant replacement therapy (srt) |
| title | A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants |
| title_full | A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants |
| title_fullStr | A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants |
| title_full_unstemmed | A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants |
| title_short | A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants |
| title_sort | randomized single blind comparison trial of beractant beraksurftm versus poractant alfa curosurf r in the treatment of respiratory distress syndrome in preterm infants |
| topic | beractant poractant alfa respiratory distress syndrome (rds) surfactant surfactant replacement therapy (srt) |
| url | https://ps.tbzmed.ac.ir/PDF/ps-29-52.pdf |
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