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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00215540
• Other study ID #: KL4-BPD-01
• Status: Terminated
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: May 11, 2012
• Start date: February 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2012
• Source: Discovery Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Premature Birth
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Discovery Laboratories, Inc.	Warrington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Discovery Laboratories, Inc.

Country where clinical trial is conducted

United States, 

References & 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 bronchop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	All-cause Mortality		36 weeks PMA	No
Secondary	BPD at 28 Days	BPD at 28 days of life, as determined by the need for supplemental oxygen	28 days of life	No
Secondary	BPD at 36 Weeks	BPD at 36 weeks PMA as determined by the need for supplemental oxygen	36 weeks PMA	No
Secondary	Days Receiving Mechanical Ventilation (MV)	Number of days receiving mechanical ventilation	36 weeks PMA	No
Secondary	Duration of Supplemental Oxygen	Number of days receiving supplemental oxygen through 36 weeks PMA	36 weeks PMA	No
Secondary	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	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	No
Secondary	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	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	No
Secondary	Incidence of Death or BPD at 28 Days	Death or BPD, defined as oxygen requirement at 28 days of life	28 days of life	No
Secondary	Days in Hospital	The number of days spent in the hospital through 36 weeks PMA	36 weeks PMA	No