MedTrace Logo

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

NCT00215540 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2012-06-13

Study results available
· View outcomes & findings →

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

Interventions

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).

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).

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).

Sponsors & Collaborators

  • Windtree Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carlos Guardia, MD · Windtree Therapeutics

  • Matthew M Laughon, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215540 on ClinicalTrials.gov