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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR SURVANTA


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All Clinical Trials for SURVANTA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005774 ↗ Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants Terminated National Center for Research Resources (NCRR) Phase 3 2000-05-01 Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00005774 ↗ Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants Terminated NICHD Neonatal Research Network Phase 3 2000-05-01 Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00146497 ↗ Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants Terminated China Medical University Hospital Phase 4 2004-08-01 Pulmonary inflammation plays an important role in the development of chronic lung disease (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy that could be beneficial in preventing CLD should be started very early. The investigators' previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis. Their follow-up study also suggested an increase in the incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal instillation will provide more local anti-inflammatory effects and less systemic side effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation shortly after birth. After informed consent is obtained, the infant will be randomly assigned depending on the condition of the infant. The primary outcome is the change in cytokines (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline (1mL/kg).
NCT00767039 ↗ Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Dey LP Phase 4 2005-01-01 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT00767039 ↗ Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Alan Fujii Phase 4 2005-01-01 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SURVANTA

Condition Name

Condition Name for SURVANTA
Intervention Trials
Respiratory Distress Syndrome 7
Infant, Newborn 2
Infant, Small for Gestational Age 1
Patent Ductus Arteriosus 1
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Condition MeSH

Condition MeSH for SURVANTA
Intervention Trials
Respiratory Distress Syndrome, Newborn 9
Respiratory Distress Syndrome, Adult 9
Respiratory Distress Syndrome 9
Syndrome 4
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Clinical Trial Locations for SURVANTA

Trials by Country

Trials by Country for SURVANTA
Location Trials
United States 27
Taiwan 2
China 1
Turkey 1
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Trials by US State

Trials by US State for SURVANTA
Location Trials
Michigan 4
Texas 2
Tennessee 2
Ohio 2
New Mexico 2
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Clinical Trial Progress for SURVANTA

Clinical Trial Phase

Clinical Trial Phase for SURVANTA
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for SURVANTA
Clinical Trial Phase Trials
Completed 3
Terminated 3
Unknown status 3
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Clinical Trial Sponsors for SURVANTA

Sponsor Name

Sponsor Name for SURVANTA
Sponsor Trials
NICHD Neonatal Research Network 2
China Medical University Hospital 2
Dey LP 1
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Sponsor Type

Sponsor Type for SURVANTA
Sponsor Trials
Other 31
Industry 2
NIH 1
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