CLINICAL TRIALS PROFILE FOR BERACTANT

All Clinical Trials for Beractant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01852461 ↗	Perfusion Index Variability in Respiratory Distress Syndrome	Completed	Dr. Sami Ulus Children's Hospital	N/A	2011-08-01	Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.
NCT01860014 ↗	Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage	Completed	Dr. Sami Ulus Children's Hospital	N/A	2010-03-01	The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
NCT01923844 ↗	Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide	Completed	Ege University	Phase 4	2012-03-01	Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.
NCT01941524 ↗	Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations	Completed	Poznan University of Medical Sciences	Phase 4	2013-03-03	The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.

Clinical Trial Conditions for Beractant

Condition Name

Condition Name for Beractant
Intervention	Trials
Respiratory Distress Syndrome	4
Infant,Premature	1
Patent Ductus Arteriosus	1
Poor Peripheral Perfusion	1

Condition MeSH

Condition MeSH for Beractant
Intervention	Trials
Respiratory Distress Syndrome, Newborn	6
Respiratory Distress Syndrome, Adult	6
Respiratory Distress Syndrome	6
Syndrome	4

Clinical Trial Locations for Beractant

Trials by Country

Trials by Country for Beractant
Location	Trials
Turkey	2
United States	1
Mexico	1
Poland	1

Trials by US State

Trials by US State for Beractant
Location	Trials
Massachusetts	1

Clinical Trial Progress for Beractant

Clinical Trial Phase

Clinical Trial Phase for Beractant
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
N/A	2

Clinical Trial Status

Clinical Trial Status for Beractant
Clinical Trial Phase	Trials
Completed	4
Unknown status	2
Terminated	1

Clinical Trial Sponsors for Beractant

Sponsor Name

Sponsor Name for Beractant
Sponsor	Trials
Dr. Sami Ulus Children's Hospital	2
King Edward Memorial Hospital, Mumbai	1
Ramesh K Agarwal	1

Sponsor Type

Sponsor Type for Beractant
Sponsor	Trials
Other	25