Curosurf (poractant alfa) / Chiesi - LARVOL DELTA

Pulmonary Surfactant Treatment for Preterm Infants With Respiratory Distress Syndrome: A Nationwide Survey. (PubMed, Clin Respir J) - "Surfactant use in China shows substantial between-hospital variation, particularly in delivery room access and less invasive administration. Standardized training and improved resource allocation may reduce disparities and support timely, evidence-based surfactant therapy."

Journal • Acute Respiratory Distress Syndrome • Respiratory Diseases

Administration of porcine surfactant in the treatment of a fatal case of acute respiratory distress syndrome in a cat with calicivirus pneumonia. (PubMed, JFMS Open Rep) - "To the authors' knowledge, this is the first report describing the development of ARDS from calicivirus pneumonia and the use of porcine surfactant in the treatment of ARDS in a cat. The administration of surfactant resulted in objective improvements in lung compliance."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Lung surfactants as a component of lipid nanoparticles for pulmonary mRNA delivery. (PubMed, bioRxiv) - "The resulting lung surfactant-enhanced LNPs (Surf-LNPs) exhibited substantial improvements in particle assembly, yielding an order of magnitude higher particle concentration at equivalent input conditions compared to conventional (Onpattro-like) LNP formulations. In vivo evaluation following intranasal administration further revealed enhanced mCherry expression in the lungs of mice treated with Surf-LNPs compared to conventional LNPs. Ultimately, these findings establish lung surfactant incorporation as a simple yet powerful formulation strategy to improve pulmonary gene delivery using LNPs, with the potential to significantly advance the translation of inhaled nucleic acid therapeutics."

Journal • Genetic Disorders

BuS2020: Efficacy and safety of the intratracheal administration of budesonide with surfactant in very preterm infants to prevent bronchopulmonary dysplasia: randomized clinical trial. (clinicaltrialsregister.eu) - P2/3 | N=60 | Completed | Sponsor: Fundacio De Recerca Clinic Barcelona-Institut DInvestigacions Biomediques August Pi I Sunyer | Not yet recruiting ➔ Completed

Trial completion • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Single-blind randomized clinical trial in premature infants with Respiratory Distress Syndrome (RDS) eligible for treatment with exogenous surfactant identified early by lung ultrasonography. (clinicaltrialsregister.eu) - P1/2 | N=30 | Recruiting | Sponsor: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Respiratory Diseases

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 | Recruiting | Sponsor: Medical University of Graz | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Respiratory Diseases

Comparative Safety of LISA in Preterm Neonates with RDS: A Systematic Review and Meta-Analysis (PAS 2026) - "A total of 19 RCTs (2,460 infants) and 26 non-randomized studies (2,360 infants) were identified for meta-analysis. Pairwise comparisons revealed no statistically significant differences between LISA and INSURE/ETT for most outcomes (Table 1), except for surfactant regurgitation/reflux (OR=2.29, 95%CI=1.21-4.33). Adverse event incidence rates among LISA patients were higher in non-randomized studies compared to RCTs (Table 2)."

Prematurity • Retrospective data • Review • Acute Respiratory Distress Syndrome • Respiratory Diseases

Health and Neurodevelopmental Outcomes at 2 Years of Extremely Preterm Infants Enrolled in the International PLUSS Trial of Intratracheal Budesonide (PAS 2026) - "842/1059 (80%) children were alive at 2 years' CA, and the primary outcome is available for 967/1059 (91%). Assessed infants had a mean (SD) gestational age of 25.6 (1.4) weeks and birth weight 774 (197) g. Data are being analyzed in late 2025, and the primary outcome will be presented by group overall, and by gestational age subgroups ( < 26 weeks; 26-27 weeks).Conclusion(s): It is critical to assess longer-term outcomes for EP infants enrolled in randomized trials of corticosteroid medications. We will present the 2 year outcomes for the 1059 EP infants enrolled in the PLUSS trial of intratracheal budesonide mixed with surfactant."

Neurodevelopmental • Prematurity • Asthma • Bronchopulmonary Dysplasia • Cerebral Palsy • CNS Disorders • Developmental Disorders • Immunology • Ophthalmology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases

Title: From Discovery to Delivery: The Evolution of Surfactant and Neonatal Respiratory Care (PAS 2026) - "Early trials confirmed the efficacy of exogenous surfactant and highlighted advantages of animal-derived over synthetic preparations. Meta-analyses supported higher initial dosing of poractant alfa for improved outcomes. Large randomized controlled trials such as COIN and SUPPORT shifted practice toward CPAP-first with selective surfactant, reducing mechanical ventilation exposure."

Surfactant • Acute Respiratory Distress Syndrome • Respiratory Diseases

A Study on Comparison of Efficacy Between Calfactant and Poractant Alfa In Extremely Premature Infants (<28 Weeks' Gestation) With Respiratory Distress Syndrome (PAS 2026) - "Among 63 eligible infants, 44 received CFT and 19 received PRT. Baseline characteristics (Table 1) were similar, except for higher out born status (42.1% vs. 11.4%, p=0.006) and lower antenatal steroid exposure (52.6% vs."

Clinical • Acute Respiratory Distress Syndrome • Bronchopulmonary Dysplasia • Cardiovascular • Hematological Disorders • Pulmonary Arterial Hypertension • Respiratory Diseases

The Efficacy of Surfactant (curosurf) as Vehicle for Budesonide Delivery to the Lung. (PAS 2026) - "Figure 1 showed the radioactivity or budesonide distribution in lung in rat with budesonide alone or with budesonide/surfactant. It is clear that with the use of budesonide/surfactant (curosurf), budesonide can be easily delivered to lung.Figure 2 showed that immediately after intratracheal administration of isotope labeled budesonide/surfactant (curosurf) without prior IMV.Figure 3 showed that after ventilation (VT 8 ml/kg, FiO2 0.6) for 6 hours, with or without LPS, and also 12 hours, budesonide delivery to lung was very low.Conclusion(s): Intratracheal B/S was administered to rat who has been on IMV for 6-12 hours. Budesonide radioactivity was rarely detected in the lung."

Clinical • Surfactant • Respiratory Diseases

Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome (clinicaltrials.gov) - P4 | N=234 | Recruiting | Sponsor: Uludag University | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Respiratory Diseases

Endotracheal surfactant for infants with life-threatening bronchiolitis (BESS): a randomised, blinded, sham-controlled, phase 2 trial. (PubMed, Lancet Respir Med) - P2 | "Poractant alfa, administered endotracheally to infants with early critical bronchiolitis, although safe, did not reduce the duration of IMV compared with the sham intervention. Therefore, our findings suggest that it should not be used for this indication at this dose and administration method."

Journal • P2 data • Critical care • Pediatrics • Pulmonary Disease • Respiratory Diseases

Late-Breaking Studies Affecting Patient Outcomes I (SCCM 2026) - "Learning Objectives: • Evaluate evidence from a multinational phase II trial, which found that early endotracheal poractant alfa did not reduce duration of invasive mechanical ventilation or improve clinical outcomes in critically ill infants with bronchiolitis • Describe the key components of the OCEAN‑ICU tool • Examine the association between polyunsaturated fatty acid levels and organ injury in pediatric sepsis • Review current recommendations on procalcitonin use in the emergency department for suspected sepsis and describe the methods and primary findings of the UK PRONTO Trial • Analyze the relationship between age and life-sustaining therapy (LST) limitation by describing the Ethicus-2 age substudy and summarizing the adjusted odds of any LST limitation in patients aged 80 and older versus younger than 65 Learning Objectives: • Evaluate evidence from a multinational phase II trial, which found that early endotracheal poractant alfa did not reduce duration of..."

Clinical • Late-breaking abstract • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Septic Shock

Surfactant therapy in neonatal care: advances, challenges, and practical considerations. (PubMed, Eur J Pediatr) - "Emerging innovations include SP-B/SP-C analog formulations and recombinant SP-D-based adjunct approaches, although several strategies remain investigational and require further validation. Key ongoing challenges include optimizing dosing and delivery efficiency, harmonizing monitoring and outcome definitions across studies, and improving cost-effectiveness. Overall, this review provides an updated critical perspective on surfactant therapy and future directions toward more individualized neonatal respiratory care."

Journal • Review • Acute Respiratory Distress Syndrome • Immunology • Respiratory Diseases

Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome (clinicaltrials.gov) - P4 | N=234 | Not yet recruiting | Sponsor: Uludag University

New P4 trial • Acute Respiratory Distress Syndrome • Respiratory Diseases

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