Clinical trial NCT00215540: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome, Newborn
Premature Birth
Bronchopulmonary Dysplasia
Keywords: Double-blind
Low Birth Weight
Surfactant
Placebo-Controlled
Premature Birth
Lead sponsor: Windtree Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 136
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks
timeFrame: 36 weeks post-menstrual age (PMA)
measure: All-cause Mortality
timeFrame: 36 weeks PMA
Secondary outcomes:
measure: BPD at 28 Days
timeFrame: 28 days of life
measure: BPD at 36 Weeks
timeFrame: 36 weeks PMA
measure: Days Receiving Mechanical Ventilation (MV)
timeFrame: 36 weeks PMA
measure: Duration of Supplemental Oxygen
timeFrame: 36 weeks PMA
measure: Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)
timeFrame: 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
measure: Area Under the Curve for Mean Arterial Pressure (MAP)
timeFrame: 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
measure: Incidence of Death or BPD at 28 Days
timeFrame: 28 days of life
measure: Days in Hospital
timeFrame: 36 weeks PMA
Other outcomes:
Locations:
city: Warrington
country: United States
facility: Discovery Laboratories, Inc.
state: Pennsylvania
Study officials:
affiliation: Windtree Therapeutics
name: Carlos Guardia, MD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Matthew M Laughon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.