Suspended

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

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What is being tested

Lucinactant

+ Standard Care

DrugOther
Who is being recruted

Urogenital Diseases+12

+ Female Urogenital Diseases and Pregnancy Complications

+ Fetal Diseases

+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2000
See protocol details

Summary

Principal SponsorWindtree Therapeutics
Last updated: May 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2000

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses. Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization. Patients are followed for 12 months.

NCT00004500
Principal SponsorWindtree Therapeutics
Last updated: May 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsFetal DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPregnancy ComplicationsRespiration DisordersPathological Conditions, Signs and SymptomsDisease AttributesLung InjuryMeconium Aspiration SyndromeRespiratory Tract DiseasesRare Diseases

Criteria

6 inclusion criteria required to participate
Continuous mechanical ventilation (CMV) at time of entry
Diagnosis of meconium aspiration syndrome (MAS)
Enrollment within 48 hours of birth
Gestational age of >= 37 weeks
Show More Criteria
8 exclusion criteria prevent from participating
Congenital anomalies likely to affect any primary or secondary endpoints
Evidence of overwhelming bacterial infection at time of randomization
Hydrops fetalis
Markedly labile persistent pulmonary hypertension at time of randomization
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Lucinactant via bronchoaveolar lavage

Group II

Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Discovery Laboratories, Inc.

Warrington, United StatesOpen Discovery Laboratories, Inc. in Google Maps
SuspendedOne Study Center