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SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.

This study has been terminated.
(Concerns related to availability of drug product)
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00215540
First received: September 14, 2005
Last updated: May 11, 2012
Last verified: May 2012

September 14, 2005
May 11, 2012
February 2005
July 2006   (final data collection date for primary outcome measure)
  • Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks [ Time Frame: 36 weeks post-menstrual age (PMA) ] [ Designated as safety issue: No ]
    Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
  • All-cause Mortality [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
  • o Incidence of death or BPD at 28 days and 36 weeks PMA
  • • Safety
  • • Efficacy
  • o Proportion of infants remaining on mechanical ventilation or oxygen over time
  • o AUC day 3-28 FiO2 and MAP between treatment groups
Complete list of historical versions of study NCT00215540 on ClinicalTrials.gov Archive Site
  • BPD at 28 Days [ Time Frame: 28 days of life ] [ Designated as safety issue: No ]
    BPD at 28 days of life, as determined by the need for supplemental oxygen
  • BPD at 36 Weeks [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
    BPD at 36 weeks PMA as determined by the need for supplemental oxygen
  • Days Receiving Mechanical Ventilation (MV) [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
    Number of days receiving mechanical ventilation
  • Duration of Supplemental Oxygen [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
    Number of days receiving supplemental oxygen through 36 weeks PMA
  • Area Under the Curve for Fraction of Inspired Oxygen (FiO₂) [ 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 ] [ Designated as safety issue: No ]
    AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
  • Area Under the Curve for Mean Arterial Pressure (MAP) [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days of life ] [ Designated as safety issue: No ]
    Death or BPD, defined as oxygen requirement at 28 days of life
  • Days in Hospital [ Time Frame: 36 weeks PMA ] [ Designated as safety issue: No ]
    The number of days spent in the hospital through 36 weeks PMA
All-cause mortality
Not Provided
Not Provided
 
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
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

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Respiratory Distress Syndrome, Newborn
  • Premature Birth
  • Bronchopulmonary Dysplasia
  • Drug: Lucinactant 175 mg/kg
    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).
    Other Names:
    • SURFAXIN
    • Lucinactant
    • Surfactant
  • Drug: Lucinactant 90 mg/kg
    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).
    Other Names:
    • SURFAXIN
    • Lucinactant
    • Surfactant
  • Drug: Placebo
    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).
    Other Names:
    • Placebo
    • Sham Air
  • Experimental: SURFAXIN High Dose
    SURFAXIN (lucinactant) at 175 mg/kg
    Intervention: Drug: Lucinactant 175 mg/kg
  • Experimental: SURFAXIN Low Dose
    SURFAXIN (lucinactant) at 90 mg/kg
    Intervention: Drug: Lucinactant 90 mg/kg
  • Placebo Comparator: Placebo
    Sham air using 3.0 mL/kg volume of air
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
up to 10 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215540
KL4-BPD-01
Yes
Discovery Laboratories, Inc.
Discovery Laboratories, Inc.
Not Provided
Study Director: Carlos Guardia, MD Discovery Laboratories, Inc.
Principal Investigator: Matthew M Laughon, MD, MPH University of North Carolina, Chapel Hill
Discovery Laboratories, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP