Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

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Brief Title

Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

Official Title

Phase 4 Study of Curosurf (Poractant) and Survanta (Beractant) Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome.

Brief Summary

      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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.

Secondary Outcome

 Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups

Condition

Prematurity

Intervention

Survanta (beractant)

Study Arms / Comparison Groups

 1
Description:  Surfactant (beractant, Survanta initial dose 100 mg/kg and subsequent doses 100 mg/kg phospholipids every 6-12 hours, as needed for up to 4 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

52

Start Date

January 2005

Completion Date

January 2009

Primary Completion Date

September 2008

Eligibility 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
      

Gender

All

Ages

N/A - 8 Hours

Accepts Healthy Volunteers

No

Contacts

Alan M Fujii, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00767039

Organization ID

H-23371


Responsible Party

Sponsor-Investigator

Study Sponsor

Alan Fujii

Collaborators

 Dey LP

Study Sponsor

Alan M Fujii, MD, Principal Investigator, Boston Medical Center


Verification Date

October 2008