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Sponsors and Collaborators: |
Boston Medical Center Dey LP |
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Information provided by: | Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT00767039 |
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.
Condition | Intervention | Phase |
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Prematurity Respiratory Distress Syndrome |
Drug: Survanta (beractant) Drug: Curosurf (poractant) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 4 Study of Curosurf and Survanta Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome. |
Estimated Enrollment: | 70 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation
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Drug: Survanta (beractant)
beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)
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2: Experimental
Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation
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Drug: Curosurf (poractant)
poractant 2.5 ml/kg/dose, initial and 1.25 ml/kg/dose subsequent (200 mg phospholipid/kg/initial dose, 100 mg/kg/subsequent dose, intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)
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Specific Aims:
We reasoned that if Curosurf was primarily responsible for improved survival rates, compared with Survanta, then there should be a sustained improvement in respiratory function in the first three days of life, when the direct pulmonary effects of the surfactant preparations would be most easily detected. It was also possible that Curosurf and Survanta could have effects on other systems that could secondarily affect long-term survival of the infant. These other organ systems would include, but not be limited to, the development of a hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how surfactant administration affected the hemodynamic precursors of these common morbidities of very premature infants.
Ages Eligible for Study: | up to 8 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alan M Fujii, MD | 617-414-3735 | Alan.Fujii@bmc.org |
United States, Massachusetts | |
Boston Medical Center | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Principal Investigator: Alan M Fujii, MD |
Principal Investigator: | Alan M Fujii, MD | Boston Medical Center |
Responsible Party: | Boston Medical Center ( Alan Fujii, MD ) |
Study ID Numbers: | H-23371 |
Study First Received: | December 17, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00767039 |
Health Authority: | United States: Institutional Review Board |
Very Premature RDS Surfactant |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult |
Poractant alfa Acute respiratory distress syndrome Beractant |
Respiratory System Agents Pathologic Processes Disease Therapeutic Uses |
Syndrome Pharmacologic Actions Pulmonary Surfactants |