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

Phase 2TerminatedNCT00215540

Windtree Therapeutics136 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

136

Conditions

Respiratory Distress Syndrome, Newborn Premature Birth Bronchopulmonary Dysplasia

Interventions

Lucinactant 175 mg/kgDRUG

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).

Lucinactant 90 mg/kgDRUG

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).

PlaceboDRUG

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).

Eligibility

Sex: ALLMin age: 3 DaysMax age: 10 Days

Medical Language ↔ Plain English

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

Locations (1)

Discovery Laboratories, Inc.

Warrington, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 36 weeks post-menstrual age (PMA)

All-cause Mortality

Time frame: 36 weeks PMA

Secondary Outcomes

BPD at 28 Days

BPD at 28 days of life, as determined by the need for supplemental oxygen

Time frame: 28 days of life

BPD at 36 Weeks

BPD at 36 weeks PMA as determined by the need for supplemental oxygen

Time frame: 36 weeks PMA

Days Receiving Mechanical Ventilation (MV)

Number of days receiving mechanical ventilation

Time frame: 36 weeks PMA

Duration of Supplemental Oxygen

Number of days receiving supplemental oxygen through 36 weeks PMA

Time frame: 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

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

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

Data from ClinicalTrials.gov

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