10 completed, 6 unknown, 4 terminated, 3 recruiting. 9 Phase 4, 7 Not applicable, 5 Phase 2, 4 Phase 3, 1 Phase 1.
Follow poractant alfa: new trials by email Literature Review of poractant alfa trials Research Report on poractant alfa
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration - Neonates and Preterm Infants, Infant Respiratory Distress Syndrome | Phase 4 | Recruiting | Medical University of Graz | 76 | 2026-02-20 | 2026-05-14 |
| Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome Poractant alfa, Calfactant - Respiratory Distress Syndrome in Premature Infants, Respiratory Distress Syndrome (RDS) | Phase 4 | Recruiting | Uludag University | 234 | 2026-01-20 | 2026-04-28 |
| Prophylactic Minimally Invasive Surfactant Evaluation Poractant Alfa - Respiratory Distress Syndrome, Newborn, Premature Birth | Phase 4 | Recruiting | Endeavor Health | 200 | 2024-01-01 | 2025-08-07 |
| Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial Poractant Alfa Intratracheal Suspension [Curosurf] - Bronchopulmonary Dysplasia, Chronic Pulmonary Insufficiency of Prematurity | Phase 2 | Unknown | VENTO GIOVANNI | 20 | 2021-12-01 | 2021-12-07 |
| Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia. Poractant Alfa Intratracheal Suspension [Curosurf], Budesonide 0.5 MG/ML - Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant | Phase 3 | Unknown | Hospital Clinic of Barcelona | 50 | 2021-10-01 | 2021-09-13 |
| Medium vs Low Oxygen Threshold for the Surfactant Administration Poractant Alfa 80 mg/mL Intratracheal Suspension - Respiratory Distress Syndrome | Phase 4 | Unknown | Virgilio Paolo Carnielli | 200 | 2021-06-01 | 2021-04-19 |
| The Budesonide in Babies (BiB) Trial budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf) - Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome | Phase 3 | Active not recruiting | NICHD Neonatal Research Network | 642 | 2021-04-01 | 2026-04-15 |
| Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS) CUROSURF® (poractant alfa) - Acute Respiratory Distress Syndrome | Phase 2 | Terminated | Chiesi Farmaceutici S.p.A. | 22 | 2021-01-06 | 2023-06-23 |
| Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19 poractant alfa - COVID-19, ARDS, Human | Phase 2 | Unknown | Dr Christophe LENCLUD | 20 | 2020-05-29 | 2021-02-03 |
| Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Curosurf, Sham - Congenital Heart Disease, Hypoplastic Left Heart Syndrome | Phase 1 | Terminated | University of Michigan | 2 | 2020-02-25 | 2023-09-13 |
| Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age Curosurf 80Mg/Ml Intratracheal Suspension, Ambient Air - Bronchiolitis, Viral | Phase 3 | Terminated | Azienda Ospedaliera Universitaria Integrata Verona | 9 | 2019-01-09 | 2021-04-15 |
| Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia. Budesonide, Poractant Alfa, Saline - Bronchopulmonary Dysplasia, Infant,Premature | Phase 4 | Unknown | Hospital Central "Dr. Ignacio Morones Prieto" | 108 | 2018-01-01 | 2019-08-07 |
| A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC) CHF5633, Poractant alfa - Respiratory Distress Syndrome, Newborn | Phase 2 | Completed | Chiesi Farmaceutici S.p.A. | 123 | 2016-01-21 | 2021-08-13 |
| Does The Surfactant Administration by Aerosolization Effective? surfactant, nasal continuous positive airway pressure, non-invasive intermittent positive-pressure ventilation - Respiratory Distress Syndrome, Surfactant Administration by Aerosolization | Not applicable | Unknown | nihat demir | 75 | 2016-01-01 | 2016-07-11 |
| Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS Poractant alfa, 200 mg/kg, Ventilator for High-frequency Oscillatory Ventilation (HFOV), Nasal Continuous Positive Airway Pressure (nCPAP) - Respiratory Distress Syndrome, Hyaline Membrane Disease | Not applicable | Completed | Catholic University of the Sacred Heart | 206 | 2015-11-01 | 2019-02-15 |
| Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome Lung lavage with surfactant, Bolus surfactant - Meconium Aspiration Syndrome | Phase 4 | Completed | Zekai Tahir Burak Women's Health Research and Education Hospital | 30 | 2013-09-01 | 2016-08-03 |
| Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome Poractant alfa, calfactant - Respiratory Distress Syndrome | Not applicable | Completed | University of Missouri-Columbia | 30 | 2013-07-01 | 2017-06-06 |
| Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome Curosurf®, Survanta® - Respiratory Distress Syndrome | Not applicable | Withdrawn | University of Michigan | 2012-06-01 | 2014-01-08 | |
| Perfusion Index Variability in Respiratory Distress Syndrome Beractant, Poractant alfa - Poor Peripheral Perfusion | Not applicable | Completed | Dr. Sami Ulus Children's Hospital | 92 | 2011-08-01 | 2013-05-13 |
| Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage Poractant alfa, Beractant - Pulmonary Hemorrhage | Not applicable | Completed | Dr. Sami Ulus Children's Hospital | 20 | 2010-03-01 | 2013-05-22 |
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Respiratory Distress Syndrome (13) · Premature Birth (10) · Bronchopulmonary Dysplasia (5) · Respiratory Distress Syndrome, Newborn (5) · COVID-19 (2) · Pulmonary Atelectasis (2) · Bronchiolitis, Viral (1) · Ductus Arteriosus, Patent (1) · Dyspnea (1) · Heart Defects, Congenital (1) · Hyaline Membrane Disease (1) · Hypoplastic Left Heart Syndrome (1) · Infant, Premature, Diseases (1) · Inflammation (1) · Lung Injury (1)
Chiesi Farmaceutici S.p.A. (3) · Dr. Sami Ulus Children's Hospital (2) · University of Michigan (2) · Alan Fujii (1) · Azienda Ospedaliera Universitaria Integrata Verona (1) · Catholic University of the Sacred Heart (1) · Dr Christophe LENCLUD (1) · Endeavor Health (1) · Hospital Central "Dr. Ignacio Morones Prieto" (1) · Hospital Clinic of Barcelona (1) · Jean Michel Hascoet (1) · Medical University of Graz (1) · NICHD Neonatal Research Network (1) · Uludag University (1) · University of Cologne (1)
United States (8) · Italy (5) · France (3) · Turkey (Türkiye) (3) · Austria (1) · Brazil (1) · Czechia (1) · Germany (1) · Mexico (1) · Portugal (1) · Spain (1) · United Kingdom (1)
Alan M Fujii, MD (1) · Alexander R Precioso, MD PhD (1) · Angela Kribs, MD (1) · Celso M Rebello, MD PhD (1) · Clark Howard, Prof. /MD (1) · Dilek Dilli, Assoc Prof (1) · Giovanni Vento, MD (1) · Giovanni Vento, Professor (1) · Laura Fabbri (1) · Marta Teresa-Palacio, MD (1) · Matthew Derrick, MBBS (1) · Namasivayam Ambalavanan, MD (1) · Naomi Lauriello, MD (1)
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