Back to resultsSURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
Primary Purpose
Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lucinactant 175 mg/kg
Lucinactant 90 mg/kg
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Distress Syndrome, Newborn focused on measuring Double-blind, Low Birth Weight, Surfactant, Placebo-Controlled, Premature Birth
Eligibility Criteria
Inclusion Criteria: Premature infants between 600 and 900 grams birth weight Intubated and on mechanical ventilation Sustained (>= 30 minutes) fraction of inspired oxygen (FiO₂) >= 0.30 within 8 hours prior to randomization Exclusion Criteria: Mother has prolonged rupture of membranes ≥ 2 weeks Culture-proven sepsis High grade intraventricular hemorrhage (IVH) Congenital heart disease Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3 FiO₂< 0.25 at any time between meeting the entry criteria to immediately prior to randomization Concomitant use of any other surfactant within the first 48 hours of life Prior use of nitric oxide Prior use of steroids Current participation in any other clinical trial or has received an experimental drug or used an experimental device
Sites / Locations
- Discovery Laboratories, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SURFAXIN High Dose
SURFAXIN Low Dose
Placebo
Arm Description
SURFAXIN (lucinactant) at 175 mg/kg
SURFAXIN (lucinactant) at 90 mg/kg
Sham air using 3.0 mL/kg volume of air
Outcomes
Primary Outcome Measures
Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks
Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
All-cause Mortality
Secondary Outcome Measures
BPD at 28 Days
BPD at 28 days of life, as determined by the need for supplemental oxygen
BPD at 36 Weeks
BPD at 36 weeks PMA as determined by the need for supplemental oxygen
Days Receiving Mechanical Ventilation (MV)
Number of days receiving mechanical ventilation
Duration of Supplemental Oxygen
Number of days receiving supplemental oxygen through 36 weeks PMA
Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Area Under the Curve for Mean Arterial Pressure (MAP)
AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Incidence of Death or BPD at 28 Days
Death or BPD, defined as oxygen requirement at 28 days of life
Days in Hospital
The number of days spent in the hospital through 36 weeks PMA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00215540
Brief Title
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of SURFAXIN® (Lucinactant), in Very Low Birth Weight (VLBW) Infants at Risk for Developing Bronchopulmonary Dysplasia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Concerns related to availability of drug product
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Windtree Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).
Detailed Description
Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
Keywords
Double-blind, Low Birth Weight, Surfactant, Placebo-Controlled, Premature Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SURFAXIN High Dose
Arm Type
Experimental
Arm Description
SURFAXIN (lucinactant) at 175 mg/kg
Arm Title
SURFAXIN Low Dose
Arm Type
Experimental
Arm Description
SURFAXIN (lucinactant) at 90 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sham air using 3.0 mL/kg volume of air
Intervention Type
Drug
Intervention Name(s)
Lucinactant 175 mg/kg
Other Intervention Name(s)
SURFAXIN, Lucinactant, Surfactant
Intervention Description
Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18).
Intervention Type
Drug
Intervention Name(s)
Lucinactant 90 mg/kg
Other Intervention Name(s)
SURFAXIN, Lucinactant, Surfactant
Intervention Description
Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sham Air
Intervention Description
Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).
Primary Outcome Measure Information:
Title
Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks
Description
Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
Time Frame
36 weeks post-menstrual age (PMA)
Title
All-cause Mortality
Time Frame
36 weeks PMA
Secondary Outcome Measure Information:
Title
BPD at 28 Days
Description
BPD at 28 days of life, as determined by the need for supplemental oxygen
Time Frame
28 days of life
Title
BPD at 36 Weeks
Description
BPD at 36 weeks PMA as determined by the need for supplemental oxygen
Time Frame
36 weeks PMA
Title
Days Receiving Mechanical Ventilation (MV)
Description
Number of days receiving mechanical ventilation
Time Frame
36 weeks PMA
Title
Duration of Supplemental Oxygen
Description
Number of days receiving supplemental oxygen through 36 weeks PMA
Time Frame
36 weeks PMA
Title
Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)
Description
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Time Frame
15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28
Title
Area Under the Curve for Mean Arterial Pressure (MAP)
Description
AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Time Frame
15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28
Title
Incidence of Death or BPD at 28 Days
Description
Death or BPD, defined as oxygen requirement at 28 days of life
Time Frame
28 days of life
Title
Days in Hospital
Description
The number of days spent in the hospital through 36 weeks PMA
Time Frame
36 weeks PMA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature infants between 600 and 900 grams birth weight
Intubated and on mechanical ventilation
Sustained (>= 30 minutes) fraction of inspired oxygen (FiO₂) >= 0.30 within 8 hours prior to randomization
Exclusion Criteria:
Mother has prolonged rupture of membranes ≥ 2 weeks
Culture-proven sepsis
High grade intraventricular hemorrhage (IVH)
Congenital heart disease
Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
FiO₂< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
Concomitant use of any other surfactant within the first 48 hours of life
Prior use of nitric oxide
Prior use of steroids
Current participation in any other clinical trial or has received an experimental drug or used an experimental device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Guardia, MD
Organizational Affiliation
Windtree Therapeutics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matthew M Laughon, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Discovery Laboratories, Inc.
City
Warrington
State/Province
Pennsylvania
ZIP/Postal Code
18976-3646
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19117865
Citation
Laughon M, Bose C, Moya F, Aschner J, Donn SM, Morabito C, Cummings JJ, Segal R, Guardia C, Liu G; Surfaxin Study Group. A pilot randomized, controlled trial of later treatment with a peptide-containing, synthetic surfactant for the prevention of bronchopulmonary dysplasia. Pediatrics. 2009 Jan;123(1):89-96. doi: 10.1542/peds.2007-2680. Erratum In: Pediatrics. 2009 May;123(5):1436.
Results Reference
result
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SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
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