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Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome Clinical research trials and Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome. Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome clinical trial. Participants frequently get the best healthcare available for their Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome  Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
For Condition: Meconium Aspiration
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Discovery Laboratories
Synopsis: OBJECTIVES: I. Determine the safety and efficacy of lucinactant in full term newborn infants with meconium aspiration syndrome.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /2 Days
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of meconium aspiration syndrome with respiratory distress and meconium staining at birth, in airways, or in bronchial secretions, in which there is no other major cause for respiratory distress Conventional intermittent mandatory ventilation At least 37 weeks gestational age --Patient Characteristics-- Renal: No oligohydramnios with renal dysgenesis Cardiovascular: No congenital cyanotic heart disease Pulmonary: No airway anomalies; No lung hypoplasia; No pulmonary hemorrhage; No pulmonary interstitial emphysema, uncontrollable air leaks, pneumothorax, pneumomediastinum, or pneumopericardium; Oxygenation index at least 5 and no greater than 30 on a single arterial blood gas reading within 60 minutes prior to study; No diaphragmatic hernia Neurologic: No known grade III or IV intraventricular hemorrhage; No obvious CNS abnormalities or malformations Other: No hydrops fetalis immune and nonimmune; No prolonged (at least 3 weeks) rupture of the fetal membranes
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
ThomasWiswell, Study Chair, Discovery Laboratories
Discovery Laboratories, Inc. *Recruiting*
Doylestown, Pennsylvania, 18901
United States
Recruiting Thomas Wiswell 215-340-4699
Additional Information:
Study ID Numbers: 199/14367; ATI-FDR001424
Study Start Date: November 2000
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004500
Other Meconium Aspiration Studies:
1. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
2. Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
3. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
Related Studies:
Other Meconium Aspiration Clinical Trials
Other Pennsylvania Clinical Trials
Other Doylestown Clinical Trials
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
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