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NCT00215540 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Windtree Therapeutics.

Terminated
Registry status
Phase 2
Development phase
136
Enrollment target

NCT00215540: Clinical Trial Phase 2 study, sponsored by Windtree Therapeutics.

NCT00215540 is a Phase 2 study that was terminated before completion, run by Windtree Therapeutics. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00215540, a Phase 2 study, was terminated before completion, sponsored by Windtree Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
136 participants
Enrollment target

Study 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).

Primary Outcome

Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age

Interventions

  • DRUG Placebo
  • DRUG Lucinactant 175 mg/kg
  • DRUG Lucinactant 90 mg/kg

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2005-02
Est. Completion 2006-07
Phase Phase 2
Windtree Therapeutics

11 total trials

Why NCT00215540 stopped before completion

NCT00215540 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00215540 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00215540 about?

NCT00215540 is a clinical study titled "SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.". 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...

What is the current status of trial NCT00215540?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2005-02. Estimated completion is 2006-07.

What interventions are being tested in trial NCT00215540?

The interventions under investigation include: Placebo (DRUG), Lucinactant 175 mg/kg (DRUG), Lucinactant 90 mg/kg (DRUG).

Who is sponsoring clinical trial NCT00215540?

This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00215540's enrollment target sits among peer trials

136 527th of 2000 higher than 1,469 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00215540, the US trial registry maintained by the National Library of Medicine. NCT00215540 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.