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Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
This study is currently recruiting participants.
Verified by Boston Medical Center, October 2008
Sponsors and Collaborators: Boston Medical Center
Dey LP
Information provided by: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00767039
  Purpose

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
Prematurity
Respiratory Distress Syndrome
Drug: Survanta (beractant)
Drug: Curosurf (poractant)
Phase IV

MedlinePlus related topics: Premature Babies
Drug Information available for: Beractant Curosurf
U.S. FDA Resources
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.

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Comparison of the respiratory support index (FIO2, mean airway pressure, respiratory index, oxygenation index) for Curosurf and Survanta over the first 3 days of life. [ Time Frame: 3 days after surfactant administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Organ blood flow responses to Curosurf and Survanta, to brain, through the Patent Ductus Arteriosus and superior mesenteric artery [ Time Frame: First hour after surfactant adminsitration ] [ Designated as safety issue: No ]
  • Chronic lung disease or death [ Time Frame: duration of NICU stay ] [ Designated as safety issue: No ]

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
1: Active Comparator
Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation
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)
2: Experimental
Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation
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)

Detailed Description:

Specific Aims:

  • To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus Survanta
  • To determine whether Curosurf is associated with a higher incidence of hemodynamically significant PDA, compared with Survanta
  • To determine whether there is a difference in the cerebral blood flow response to Curosurf versus Survanta
  • To determine whether there is a difference in morbidity in very premature infants treated with Curosurf versus Survanta

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.

  Eligibility

Ages Eligible for Study:   up to 8 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • <29 6/7 and >24 0/7 weeks gestational age
  • Inborn at the participating institution enrolling the patient
  • FIO2 >25% and Intubated with mean airway pressure > 5 cm H20
  • <8 hours age at randomization
  • Signed informed consent from parent(s)

Exclusion Criteria:

  • <500 g birth weight
  • <24 0/7 weeks gestational age (best estimate)
  • Prolonged Premature Rupture of membranes >3 weeks (21 days)
  • Apgar score < 3 at 5 minutes
  • Impending death anticipated within the first 3 days of life, moribund
  • Severe congenital anomalies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767039

Contacts
Contact: Alan M Fujii, MD 617-414-3735 Alan.Fujii@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Alan M Fujii, MD            
Sponsors and Collaborators
Boston Medical Center
Dey LP
Investigators
Principal Investigator: Alan M Fujii, MD Boston Medical Center
  More Information

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

Keywords provided by Boston Medical Center:
Very Premature
RDS
Surfactant

Study placed in the following topic categories:
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Poractant alfa
Acute respiratory distress syndrome
Beractant

Additional relevant MeSH terms:
Respiratory System Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Pharmacologic Actions
Pulmonary Surfactants

ClinicalTrials.gov processed this record on January 16, 2009