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

This study has been terminated.
(Slow recruitment,changes in protocols, larger than anticipated differences)
Sponsor:
Collaborator:
Dey LP
Information provided by (Responsible Party):
Alan Fujii, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00767039
First received: December 17, 2007
Last updated: September 28, 2011
Last verified: October 2008
History of Changes
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prematurity
Respiratory Distress Syndrome
Patent Ductus Arteriosus
Interventions: Drug: Survanta (beractant)
Drug: Curosurf (poractant)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients born between 1/2005 and 5/2008 with respiratory distress syndrome requiring mechanical ventilation, <30 weeks gestation, greater than 500 g and whose parents provided informed consent were included in the study. Infants with multiple congenital anomalies, significant congenital heart disease were excluded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Beractant Arm Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
Poractant Alfa Arm Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)

Participant Flow:   Overall Study
    Beractant Arm     Poractant Alfa Arm  
STARTED     27 [1]   25  
COMPLETED     22     23  
NOT COMPLETED     5     2  
Death                 5                 2  
[1] Two early deaths and 3 late deaths occurred in this group



  Baseline Characteristics
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Reporting Groups
  Description
Beractant Arm Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
Poractant Alfa Arm Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Total Total of all reporting groups

Baseline Measures
    Beractant Arm     Poractant Alfa Arm     Total  
Number of Participants  
[units: participants]
 		  27     25     52  
Age [1]
[units: years]
 		     
<=18 years     27     25     52  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     7     13     20  
Male     20     12     32  
Region of Enrollment  
[units: participants]
 		     
United States     27     25     52  
Gestational Age in weeks [2]
[units: weeks]
Mean ± Standard Deviation 		  26.7  ± 1.7     27.1  ± 1.6     26.9  ± 1.6  
[1] The population is recruited from premature infants with Respiratory Distress Syndrome on the first day of life.
[2] All patients are enrolled on the first day of life. Therefore the mean +/- SD = 0 +/- 0 years.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.   [ Time Frame: 48 hours after surfactant administration ]
  Show Outcome Measure 1

2.  Primary:   Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration   [ Time Frame: 72 hours after surfactant administration ]
  Show Outcome Measure 2

3.  Primary:   Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.   [ Time Frame: 48 hours after surfactant administration ]
  Show Outcome Measure 3

4.  Primary:   Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.   [ Time Frame: 72 hours after surfactant administration ]
  Show Outcome Measure 4

5.  Secondary:   Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups   [ Time Frame: 48 hours after surfactant administration ]
  Show Outcome Measure 5

6.  Secondary:   Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups   [ Time Frame: 72 hours after surfactant administration ]
  Show Outcome Measure 6

7.  Secondary:   Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)   [ Time Frame: Hemodynamically significant PDA at > 2 days ]
  Show Outcome Measure 7

8.  Secondary:   Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)   [ Time Frame: First hour after 2nd surfactant dose ]
  Show Outcome Measure 8

9.  Secondary:   Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant   [ Time Frame: One hour following second surfactant dose at 12-24 hours after initial dose ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant
Measure Description Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.
Time Frame One hour following second surfactant dose at 12-24 hours after initial dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.

Reporting Groups
  Description
Beractant Arm Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
Poractant Alfa Arm Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)

Measured Values
    Beractant Arm     Poractant Alfa Arm  
Number of Participants Analyzed  
[units: participants]
 		  9     7  
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant  
[units: Percent change from baseline velocity]
Mean ± Standard Error 		   
Blood Flow Velocity, before surfactant (cm/sec)     12.5  ± 1.5     22.4  ± 2.8  
Peak Blood Flow Velocity, post surfactant (cm/sec)     18.3  ± 2.4     20.4  ± 2.1  
Peak Change in Blood Flow Velocity (cm/sec)     5.6  ± 1.3     -2.0  ± 3.1  
Percent Change in Blood Flow Velocity (%)     47.4  ± 11.9     -1.8  ± 14.6  


Statistical Analysis 1 for Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] <0.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)   [ Time Frame: 36 weeks post menstrual age ]
  Show Outcome Measure 10

11.  Secondary:   Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.   [ Time Frame: NICU hospitalization, up to 42 weeks post menstrual age ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The primary limitations are the small number of patients, the high rate of chronic lung disease in the beractant group and the open-label design of the study.  


Results Point of Contact:  
Name/Title: Alan Fujii MD (PI)
Organization: Boston Medical Center
phone: 617-4414-3735
e-mail: Alan.Fujii@bmc.org


Publications of Results:


Responsible Party: Alan Fujii, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00767039     History of Changes
Other Study ID Numbers: H-23371
Study First Received: December 17, 2007
Results First Received: April 27, 2011
Last Updated: September 28, 2011
Health Authority: United States: Institutional Review Board