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

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:

MedlinePlus related topics: Birth Weight

Drug Information available for: Sinapultide Lucinactant

U.S. FDA Resources

Further study details as provided by Discovery Laboratories:

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

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

Investigators

Study Director:	Carlos Guardia, MD	Discovery Laboratories
Principal Investigator:	Matthew M Laughon, MD, MPH	University of North Carolina, Chapel Hill

More Information

Publications:

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.

Responsible Party:	Discovery Laboratories
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:

Double-blind
Low Birth Weight
Surfactant
Placebo-Controlled
Premature Birth

Additional relevant MeSH terms:

Birth Weight
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Hyperplasia
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases

Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiration Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013