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

NCT00215540 | Terminated Phase 2 Results DMC

• 1 other identifier: KL4-BPD-01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Bronchopulmonary Dysplasia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  36 weeks post-menstrual age (PMA)

• All-cause Mortality

  36 weeks PMA

Secondary Outcomes (8)

• BPD at 28 Days

  28 days of life

• BPD at 36 Weeks

  36 weeks PMA

• Days Receiving Mechanical Ventilation (MV)

  36 weeks PMA

• Duration of Supplemental Oxygen

  36 weeks PMA

• Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)

  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

Study Arms (3)

SURFAXIN High Dose

EXPERIMENTAL

SURFAXIN (lucinactant) at 175 mg/kg

Drug: Lucinactant 175 mg/kg

SURFAXIN Low Dose

EXPERIMENTAL

SURFAXIN (lucinactant) at 90 mg/kg

Drug: Lucinactant 90 mg/kg

Placebo

PLACEBO COMPARATOR

Sham air using 3.0 mL/kg volume of air

Drug: Placebo

Interventions

Lucinactant 175 mg/kg DRUG

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).

Also known as: SURFAXIN, Lucinactant, Surfactant

SURFAXIN High Dose

Lucinactant 90 mg/kg DRUG

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).

Also known as: SURFAXIN, Lucinactant, Surfactant

SURFAXIN Low Dose

Placebo DRUG

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).

Also known as: Sham Air

Placebo

Eligibility Criteria

• Age: 3 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Windtree Therapeutics: lead

Study Sites (1)

Discovery Laboratories, Inc.

Warrington, Pennsylvania, 18976-3646, United States

Location

Related Publications (1)

• 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.

  PMID: 19117865 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Bronchopulmonary Dysplasia

Interventions

lucinactant; Surface-Active Agents

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Robert Segal
• Organization: Discovery Laboratories, Inc.

rsegal@discoverylabs.com

215-488-9300

Study Officials

• Carlos Guardia, MD

  Windtree Therapeutics

  STUDY DIRECTOR

• Matthew M Laughon, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: June 13, 2012
• Results First Posted: June 13, 2012

Record last verified: 2012-05

Locations

US (1)