Who is sponsoring NCT00004500?

NCT00004500 is sponsored by Windtree Therapeutics.

What condition does NCT00004500 study?

NCT00004500 studies Meconium Aspiration.

What drugs are being tested in NCT00004500?

Interventions: Lucinactant, Standard Care.

What is the status of NCT00004500?

NCT00004500 is currently TERMINATED.

Last reviewed 2012-05-01 · How we verify

A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants

NCT00004500 Phase 3 TERMINATED Results posted

OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

Details

Lead sponsor	Windtree Therapeutics
Phase	Phase 3
Status	TERMINATED
Enrolment	69
Start date	2000-03
Completion	2004-11

Conditions

Meconium Aspiration

Interventions

Lucinactant
Standard Care

Primary outcomes

Number of Days Receiving Mechanical Ventilation (MV) — 28 days
A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.

Countries

United States