Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 179 for:    Phospholipids

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00767039
Recruitment Status : Terminated (Slow recruitment,changes in protocols, larger than anticipated differences)
First Posted : October 6, 2008
Results First Posted : September 20, 2011
Last Update Posted : October 3, 2011
Sponsor:
Collaborator:
Dey LP
Information provided by (Responsible Party):
Alan Fujii, Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prematurity
Respiratory Distress Syndrome
Patent Ductus Arteriosus
Interventions Drug: Survanta (beractant)
Drug: Curosurf (poractant)
Enrollment 52
Recruitment Details 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  
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description 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) 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)
Period Title: Overall Study
Started 27 [1] 25
Completed 22 23
Not Completed 5 2
Reason Not Completed
Death             5             2
[1]
Two early deaths and 3 late deaths occurred in this group
Arm/Group Title Beractant Arm Poractant Alfa Arm Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 27 25 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 52 participants
<=18 years
27
 100.0%
25
 100.0%
52
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: The population is recruited from premature infants with Respiratory Distress Syndrome on the first day of life.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 52 participants
Female
7
  25.9%
13
  52.0%
20
  38.5%
Male
20
  74.1%
12
  48.0%
32
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 25 participants 52 participants
27 25 52
Gestational Age in weeks   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 27 participants 25 participants 52 participants
26.7  (1.7) 27.1  (1.6) 26.9  (1.6)
[1]
Measure Description: All patients are enrolled on the first day of life. Therefore the mean +/- SD = 0 +/- 0 years.
1.Primary Outcome
Title Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Hide Description Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.
Time Frame 48 hours after surfactant administration
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: cm H20
8.6  (0.8) 6.4  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive >/= 3 days were included in the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration
Hide Description Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.
Time Frame 72 hours after surfactant administration
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: cm H20
7.9  (0.6) 6.0  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Hide Description Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Time Frame 48 hours after surfactant administration
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: cm H20-Percent of O2
274  (35) 170  (18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.
Hide Description Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Time Frame 72 hours after surfactant administration
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: cm H20-Percent of O2
226  (29) 140  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Hide Description Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.
Time Frame 48 hours after surfactant administration
Hide Outcome Measure Data
Hide Analysis Population Description
Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 27 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Participants successfully extubated
6
(3 to 10)
13
(9 to 17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.19 to 0.95
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Hide Description Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.
Time Frame 72 hours after surfactant administration
Hide Outcome Measure Data
Hide Analysis Population Description
Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 27 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Participants successfully extubated
8
(5 to 12)
15
(11 to 19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.25 to 0.96
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)
Hide Description Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.
Time Frame Hemodynamically significant PDA at > 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Subjects
19
(15 to 22)
8
(5 to 12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.38
Confidence Interval (2-Sided) 95%
1.29 to 4.38
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)
Hide Description Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.
Time Frame First hour after 2nd surfactant dose
Hide Outcome Measure Data
Hide Analysis Population Description
Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 9 7
Mean (Standard Error)
Unit of Measure: cc/min
Baseline PDA Flow, before surfactant (cc/min) 138  (36) 123  (45)
Maximal PDA Flow, following surfactant (cc/min) 169  (52) 143  (35)
Change in PDA Flow, following surfactant (cc/min) 32  (42) 20  (37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 9 7
Mean (Standard Error)
Unit of Measure: Percent change from baseline velocity
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)
Hide Description Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.
Time Frame 36 weeks post menstrual age
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Surviving Subjects with BPD
11
(7 to 15)
8
(4 to 11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.71 to 2.89
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.
Hide Description Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.
Time Frame NICU hospitalization, up to 42 weeks post menstrual age
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 27 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Subjects with BPD + Neonatal Deaths
16
(12 to 20)
10
(6 to 14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beractant Arm, Poractant Alfa Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.48
Confidence Interval (2-Sided) 90%
0.84 to 2.63
Estimation Comments [Not Specified]
Time Frame Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age.
Adverse Event Reporting Description Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
 
Arm/Group Title Beractant Arm Poractant Alfa Arm
Hide Arm/Group Description 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) 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)
All-Cause Mortality
Beractant Arm Poractant Alfa Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Beractant Arm Poractant Alfa Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/27 (70.37%)      9/25 (36.00%)    
Eye disorders     
ROP Stage II-IV  [1]  10/23 (43.48%)  10 7/24 (29.17%)  7
Gastrointestinal disorders     
Necrotizing Enterocolitis  [2]  4/27 (14.81%)  4 4/25 (16.00%)  4
General disorders     
Death  [3]  5/27 (18.52%)  5 2/25 (8.00%)  2
Nervous system disorders     
Severe Intraventricular Hemorrahge (Grade 3-4)   1/27 (3.70%)  1 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
Significant Pulmonary Hemorrhage  [4]  3/27 (11.11%)  3 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
[1]
Retinopathy of Prematurity at threshold, treated with Laser
[2]
Stage 2 Necrotizing enterocolitis
[3]
Death before NICU discharge
[4]
Pulmonary hemorrhage associated with an increase in respiratory support
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Beractant Arm Poractant Alfa Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/27 (62.96%)      8/25 (32.00%)    
Cardiac disorders     
Patent Ductus Arteriosus ligation  [1]  7/25 (28.00%)  7 4/25 (16.00%)  4
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary Dysplasia  [2]  11/22 (50.00%)  11 8/23 (34.78%)  8
Pulmonary Air Leak  [3]  4/27 (14.81%)  4 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
PDA requiring surgical ligation
[2]
Oxygen requirement at 36 weeks Post menstrual age in infants surviving to 36+ weeks.
[3]
Pulmonary air leak including: pulmonary interstitial emphysema, pneumothorax, pneumatocele
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alan Fujii MD (PI)
Organization: Boston Medical Center
Phone: 617-4414-3735
Other Publications:
Fujii AM, Editorial. Is There Really A Clinical Difference In Surfactant Preparations? J Perinatol 2010; 30:698; doi:10,1038/jp.2010.90
Fujii A. Editorial. Are all animal derived surfactants the same? The e-NeoResearch 2011; 1 (1); 50-51.
Responsible Party: Alan Fujii, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00767039     History of Changes
Other Study ID Numbers: H-23371
First Submitted: December 17, 2007
First Posted: October 6, 2008
Results First Submitted: April 27, 2011
Results First Posted: September 20, 2011
Last Update Posted: October 3, 2011