Curosurf (poractant alfa) / Chiesi - LARVOL DELTA

SurfStab I: Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes (clinicaltrials.gov) - P4 | N=76 | Not yet recruiting | Sponsor: Medical University of Graz

New P4 trial • Acute Respiratory Distress Syndrome • Respiratory Diseases

SurfON trial: study protocol for a multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress. (PubMed, Trials) - "Evidence-based guidance for the management of late preterm and early term infants is sparse, and no previous large randomised controlled trials have focused on this population. Management of respiratory distress in late preterm and early term infants varies. Some clinicians prefer early surfactant administration to prevent deterioration-78others delay treatment to avoid mechanical ventilation. This inconsistency highlights the need for trials to establish an evidence base. Unexpected neonatal morbidity and prolonged hospitalisation cause significant psychological distress for families, impacting breastfeeding and maternal well-being. High intensive care workload and associated costs pose challenges for the NHS (National Health Service). Evidence-based management could improve outcomes and reduce healthcare burdens."

Journal • CNS Disorders • Critical care • Respiratory Diseases

A systematic scoping review of the use of surfactant replacement therapy for respiratory distress syndrome in preterm neonates in low- and middle-income countries. (PubMed, Front Pediatr) - "Poractant alfa (200 mg/kg) is conditionally recommended in preference to beractant (100 mg/kg). Regionally relevant cost-effectiveness studies are needed."

Journal • Review • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Procedural success and safety of a standardized less invasive surfactant administration protocol using fentanyl premedication and video laryngoscopy in preterm infants <32 weeks' gestation. (PubMed, Front Pediatr) - "This study provides detailed data on the procedural quality of LISA when opioid analgesia and video laryngoscopy are used. This data may inform future trials investigating analgesia strategies, safety, and long-term outcomes."

Journal • Video • Acute Respiratory Distress Syndrome • Anesthesia • Cardiovascular • Hypotension • Palliative care • Respiratory Diseases

The Budesonide in Babies (BiB) Trial (clinicaltrials.gov) - P3 | N=642 | Active, not recruiting | Sponsor: NICHD Neonatal Research Network | N=1160 ➔ 642

Enrollment change • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Cost-Effectiveness Analysis of Poractant Alfa vs. Calfactant in the Management of Neonatal Respiratory Distress Syndrome in Tunisia (ISPOR-EU 2025) - "Although associated with higher costs, poractant alfa resulted in significantly fewer severe neonatal complications. The observed ICERs suggest a favorable cost-effectiveness profile. These findings underscore the importance of context-specific pharmacoeconomic evaluations to inform evidence-based resource allocation in neonatal intensive care."

Cost effectiveness • HEOR • Acute Respiratory Distress Syndrome • Gastrointestinal Disorder • Hematological Disorders • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

Economic Evaluation of Surfactant Therapy for Neonatal Respiratory Distress Syndrome: 5-Year Real-World Evidence on Poractant Alfa vs. Beractant From the IMSS Perspective in Mexico (ISPOR-EU 2025) - "Over five years of real-world use within IMSS, Poractant Alpha proved to be a dominant strategy, delivering superior clinical outcomes and greater cost-efficiency in the treatment of neonatal RDS in Mexico's public healthcare system."

Clinical • HEOR • Real-world • Real-world evidence • Surfactant • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Lung ultrasound imaging can effectively monitor and guide treatment with pulmonary surfactant for preterm infants of pulmonary consolidation: a prospective observational cohort study. (PubMed, Front Pediatr) - "While TTN can be treated with a fixed-dose regimen, NRDS has a dose-response relationship that supports customized dosage. The frequency and timing of surfactant administration in preterm newborns are determined by LUS-detected lung consolidation, which also acts as a decision-making indicator for PS therapy."

Journal • Observational data • Acute Respiratory Distress Syndrome • Critical care • Obstetrics • Respiratory Diseases

Comparison of Clinical Outcomes Between Calfactant and Poractant-Alfa in Preterm Infants with Respiratory Distress Syndrome. (PubMed, Children (Basel)) - "Compared with calfactant, poractant alfa offers practical advantages-such as a higher initial dose, lower cost, and reduced need for a second repeat dose-while yielding comparable short- and mid-term morbidity and mortality outcomes."

Clinical data • Journal • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants: The Budesonide in Babies (BiB) Randomized Clinical Trial. (PubMed, JAMA) - P3 | "In this large multicenter trial, the combination of budesonide with surfactant did not reduce the risk of BPD or death at 36 weeks' postmenstrual age in extremely preterm infants. ClinicalTrials.gov Identifier: NCT04545866."

Clinical • Journal • Bronchopulmonary Dysplasia • Diabetes • Pulmonary Disease • Respiratory Diseases

A novel SP-B/SP-C fusion peptide surfactant improves lung function and resists inactivation in experimental RDS (ERS 2025) - "The synthetic Combo surfactant is therapeutically effective in an experimental RDS model and demonstrates superior resistance to plasma protein inhibition in vitro , suggesting its potential for treating acute lung injury. Supported by: VEGA 1/0026/25, VEGA 1/0097/23"

Surfactant • Acute Lung Injury • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants(28+0 to 34+6 Week) With Respiratory Distress Syndrome: A Randomized Controlled Trial. (PubMed, Pediatr Pulmonol) - "In LMIC settings, BLES and poractant alfa showed similar effectiveness for RDS management via LISA, with no difference in clinical outcomes. BLES provides a cost-effective alternative in resource-constrained neonatal care."

Clinical • Journal • Acute Respiratory Distress Syndrome • Critical care • Respiratory Diseases

Surfactant Delivery Is Crucial for Enhancing Function of Ex-Vivo Premature Sheep Lungs: A Feasibility Study. (PubMed, Pediatr Pulmonol) - "In ex-vivo preterm sheep lungs, surfactant delivery is the primary driver of improved lung function, while PEEP has a smaller impact. The xPULM lung simulator enables research during spontaneous breathing while avoiding ethical issues associated with animal models."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Respiratory Diseases

Therapeutic efficacy of budesonide suspension combined with poractant alfa injection for neonatal respiratory distress syndrome and its effect on serum ferritin and PAI-1 expressions. (PubMed, Pak J Med Sci) - "Compared with poractant alfa injection, budesonide suspension combined with poractant alfa injection is more effective in treatment of NRDS. The action mechanisms may be related to its further reduction of inflammatory response and inhibition of serum ferritin and plasminogen activator inhibitor-1 expressions."

Journal • Acute Respiratory Distress Syndrome • Oncology • Respiratory Diseases • CRP • IL6 • TNFA

Characterization of atomization and delivery efficiency of exogenous surfactant in preterm infant lungs using an ex vivo respiratory model. (PubMed, Sci Rep) - "This preliminary study confirmed the promising potential of Curosurf atomization via the Endosurf device for the distribution of surfactant in the lungs of infants with RDS. These advances could help to improve the treatment of RDS in preterm infants and offer new perspectives for healthcare professionals and affected families."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Respiratory Diseases

Less Invasive Surfactant Administration (LISA) versus Intubation Surfactant Extubation (InSurE) technique using higher volume surfactant in management of neonates with respiratory distress syndrome: an open-label randomized controlled trial. (PubMed, Eur J Pediatr) - "LISA and InSurE are equally feasible strategies for surfactant administration in the treatment of neonatal RDS using NIPPV as primary respiratory support. Both groups had comparable outcomes using larger volume, cost effective bovine lipid extract surfactant with no added advantage of LISA as compared to InSurE technique."

Clinical • Intubation • Journal • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Cardiovascular • Pulmonary Disease • Respiratory Diseases

Preclinical Testing of a New Dry Powder Aerosol Synthetic Lung Surfactant Formulation and Device Combination for the Treatment of Neonatal Respiratory Distress Syndrome. (PubMed, J Aerosol Med Pulm Drug Deliv) - "Biological response for the D3-MSD2 aerosol therapy was also superior with 2-fold improvement in final lung compliance compared with liquid Curosurf. The new D3-MSD2 aerosol therapy was found to be superior to clinical-practice liquid bolus instillation in the critical areas of required dose (order-of-magnitude reduction), delivery time, biological response rate, and efficacy."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Respiratory Diseases

Outcomes after implementation of Minimally Invasive Surfactant Therapy (MIST) in a Neonatal Intensive Care Unit (NICU) (PAS 2025) - "There were no significant differences in rates of BPD between the patients who received MIST compared to InSurE (Table 1). Additionally, there were no significant differences in secondary outcomes, including grade III or IV intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), air leak requiring drainage, retinopathy of prematurity (ROP) requiring treatment, and necrotizing enterocolitis (NEC) (Table 1). Significantly less patients in the MIST group (1%) received premedication compared to InSurE group (16%) (p=0.003, Table 1)."

Surfactant • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Critical care • Gastrointestinal Disorder • Hematological Disorders • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

A Comparison of the Effect of Beractant (Beracsurf) and Proctant Alpha (Curosurf) in Neonatal Respiratory Distress: A Randomized Controlled Trial. (PubMed, Iran J Med Sci) - "The mortality rate in the Curosurf group was 24.3% (95% CI=10.5%-38.1%); while in the Beracsurf group, it was 10.6% (95% CI=1.8%-19.5%) (P=0.09). Beracsurf had comparable efficacy to Curosurf and could be considered a viable alternative.Trial Registration Number: IRCT20120126008827N3."

Clinical • Journal • Acute Respiratory Distress Syndrome • Respiratory Diseases

Comparing the Effect of Beractant (Beraksurf™) with That of Poractant Alfa (Curosurf®) on the Need for Intermittent Positive Pressure Ventilation in Neonatal Respiratory Distress Syndrome by Adopting a Semi-parametric Approach: Re-Analyzing Data of a Randomized Controlled Trial. (PubMed, BMC Pediatr) - "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."

Clinical • Journal • Acute Respiratory Distress Syndrome • Respiratory Diseases

Vitamin E Acetate Causes Softening of Pulmonary Surfactant Membrane Models. (PubMed, Chem Res Toxicol) - "Using high-resolution techniques of small-angle X-ray scattering, small-angle neutron scattering, neutron spin-echo spectroscopy, and neutron reflectometry, we compare the molecular-scale behaviors of these membranes to the bulk viscoelastic properties of surfactant monolayer films as studied by Langmuir monolayer techniques. While VEA does not obviously alter the structure or organization of PS membranes, a consistent softening of membrane systems─regardless of compositional complexity─provides a biophysical explanation for the respiratory distress associated with EVALI and yields a new perspective on the behavior of the PS system."

Journal • Respiratory Diseases

Bronchoscopic lung lavage and exogenous surfactant successfully reverse respiratory failure after severe chlorine exposure: A pediatric case report. (PubMed, Clin Case Rep) - "Given the underlying pathophysiology of chlorine lung injury characterized by surfactant dysfunction, the boy was treated with repeated bronchoscopic lung lavages followed by exogenous surfactant (Curosurf 30 mg/kg total), 1 h after intubation and subsequently after 6 and 12 h, when he achieved a significant and stable reduction in ventilatory requirements. This case study illustrates the beneficial effects of target therapy with bronchoscopic lung lavage followed by exogenous surfactant in chlorine related ARDS to prevent more invasive and costly treatments."

Journal • Acute Respiratory Distress Syndrome • Cough • Pediatrics • Pulmonary Disease • Respiratory Diseases

Risk Factors in Addition to Short and Long-Term Outcomes With Thin Catheter Surfactant Administration Failure in Preterm Infants: A Retrospective Analysis. (PubMed, J Paediatr Child Health) - "Infants who fail TCA are at increased risk for short-term complications despite favourable long-term neurodevelopmental outcomes. Identifying infants at risk of TCA failure may help early prevention of morbidities and individualise their management."

Journal • Retrospective data • Acute Respiratory Distress Syndrome • Infectious Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity • Septic Shock • Small for Gestational Age

Comparison of Efficacy of Beractant (SURVANTA®) and Poractant Alfa (CUROSURF®) in Preterm Infants With Respiratory Distress Syndrome in Tawam Hospital, Al Ain, UAE: A Retrospective Study. (PubMed, Cureus) - "However, the rates of other outcomes, including significant patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), periventricular leukomalacia (PVL), and necrotizing enterocolitis (NEC), were comparable in both treatment groups. Further randomized prospective studies are necessary to evaluate these types of surfactants and investigate their efficacy as well as both short- and long-term outcomes."

Journal • Retrospective data • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Gastrointestinal Disorder • Hematological Disorders • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants: The PLUSS Randomized Clinical Trial. (PubMed, JAMA) - P3 | "In extremely preterm infants receiving surfactant for respiratory distress syndrome, early intratracheal budesonide may have little to no effect on survival free of BPD. anzctr.org.au Identifier: ACTRN12617000322336."

Clinical • Journal • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases