3 completed, 3 terminated, 1 no longer available, 1 recruiting. 3 Phase 3, 2 Phase 4, 1 Not applicable, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 2, Recruiting 1 |
| Phase 4 | 2 | Completed 1, Terminated 1 |
| Not applicable | 1 | Terminated 1 |
| Phase 1 | 1 | Terminated 1 |
| Phase 2 | 1 | Suspended 1 |
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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 |
|---|---|---|---|---|---|---|
| Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study surfactant airway device - RDS of Prematurity, Surfactant Protein B Deficiency | Phase 2 | Suspended | ONY | 55 | 2025-02-07 | 2023-11-01 |
| InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS Infasurf Aero™ - Respiratory Distress Syndrome (Neonatal), Intubation Complication | Phase 3 | Recruiting | ONY | 220 | 2025-01-01 | 2025-03-30 |
| Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 Aerosolized Infasurf - Bronchiolitis | Phase 1 | Terminated | ONY | 13 | 2019-01-12 | 2020-10-23 |
| Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients Aerosolized Calfactant, Solarys - Respiratory Distress Syndrome | Phase 3 | Completed | ONY | 477 | 2017-03-29 | 2024-05-29 |
| Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome Endotracheal intubation, Laryngeal mask airway, remifentanil - Respiratory Distress Syndrome, Newborn | Phase 4 | Terminated | Albany Medical College | 93 | 2014-06-01 | 2023-09-21 |
| Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation Endotracheal tube insertion, Laryngeal mask airway insertion - Respiratory Distress Syndrome, Newborn | Phase 4 | Completed | Albany Medical College | 61 | 2009-12-01 | 2019-07-26 |
| Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide Infasurf (ONY Inc.), Sham - Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia | Phase 3 | Completed | Roberta Ballard | 85 | 2008-01-01 | 2021-05-11 |
| Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA) Surfactant administered via Laryngeal Mask Airway (LMA), standard of care (nasal CPAP and supplemental oxygen) - Respiratory Distress Syndrome, Newborn | Not applicable | Terminated | University of Virginia | 380 | 2005-06-01 | 2010-05-07 |
| Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03) Infasurf Aero - Neonatal Respiratory Distress | No longer available | ONY | 2023-11-07 |
Respiratory Distress Syndrome (6) · Premature Birth (4) · Pulmonary Atelectasis (3) · Respiratory Distress Syndrome, Newborn (3) · Respiratory Aspiration (2) · Bronchiolitis (1) · Bronchopulmonary Dysplasia (1) · Perinatal Death (1) · Respiratory Distress Syndrome In Premature Infants (1) · Surfactant Dysfunction (1) · Surfactant Metabolism Dysfunction, Pulmonary, 1 (1)
calfactant (3) · Intubation, Intratracheal (2) · Air (1) · Laryngeal Masks (1) · Remifentanil (1) · Standard of Care (1) · salicylhydroxamic acid (1)
United States (9)
Jim Cummings, MD (2) · Joaquim M Pinheiro, MD, MPH (2) · Dinushan Kaluarachchi, MD (1) · James Cummings, MD (1) · John Kattwinkel, MD (1) · Kari Roberts, MD (1) · Querube Santana, MD (1) · Roberta A Ballard, MD (1) · Scott Guthrie, MD (1)