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
  Purpose

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).


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Premature Birth
Bronchopulmonary Dysplasia
Drug: Lucinactant 175 mg/kg
Drug: Lucinactant 90 mg/kg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Discovery Laboratories, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 136
Study Start Date: February 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SURFAXIN High Dose
SURFAXIN (lucinactant) at 175 mg/kg
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
Experimental: SURFAXIN Low Dose
SURFAXIN (lucinactant) at 90 mg/kg
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
Placebo Comparator: Placebo
Sham air using 3.0 mL/kg volume of air
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

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).

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215540

Locations
United States, Pennsylvania
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States, 18976-3646
Sponsors and Collaborators
Discovery Laboratories, Inc.
Investigators
Study Director: Carlos Guardia, MD Discovery Laboratories, Inc.
Principal Investigator: Matthew M Laughon, MD, MPH University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00215540     History of Changes
Other Study ID Numbers: KL4-BPD-01
Study First Received: September 14, 2005
Results First Received: April 2, 2012
Last Updated: May 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Discovery Laboratories, Inc.:
Double-blind
Low Birth Weight
Surfactant
Placebo-Controlled
Premature Birth

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Premature Birth
Respiratory Distress Syndrome, Newborn
Body Weight
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Ventilator-Induced Lung Injury
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014