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Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia Clinical research trials and Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia. Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia clinical trial. Human subjects often obtain the finest healthcare possible for their Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia  Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia
Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia
For Condition: Bronchopulmonary Dysplasia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Iowa
Synopsis: OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment vs. placebo, initiated within the first month of life, on long-term pulmonary and developmental outcomes in premature infants with evolving bronchopulmonary dysplasia. II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal function.
Details: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to 1 of 3 treatment groups. The first group receives intravenous dexamethasone tapered over 42 days. The second group receives daily intravenous dexamethasone for 6 days, then intravenous methylprednisolone (MePRDL) tapered over the next 34 days, beginning on day 8. A placebo is given on "off" MePRDL days. The third group receives an intravenous placebo for 42 days, with a tapering schedule beginning day 35. All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 and/or 30, as clinically indicated. Study drugs are suspended during rescue therapy.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: /2 Weeks
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Premature infants with evolving bronchopulmonary dysplasia on chest x-ray Requirement for mechanical ventilation Fraction of inspired oxygen greater than 0.30 Ventilator at least 15 cycles/minute No signs of weaning within 72 hours prior to entry No serious congenital anomaly --Prior/Concurrent Therapy-- No prior postnatal corticosteroids --Patient Characteristics-- Cardiovascular: No congenital heart disease Other: Birth weight no greater than 1500 g Gestational age no greater than 30 weeks No contraindication to corticosteroids, e.g., culture-proven bacterial sepsis
Total Enrollment: 54
Location and Contact Information:
Overall Study Official:
RichardAhrens, Study Chair, University of Iowa
Additional Information:
Study ID Numbers: 199/11874; UIHC-69501
Study Start Date: November 1995
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004785
Other Bronchopulmonary Dysplasia Studies:
1. Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents with Infants at Risk of Sudden Death
2. Premature Birth and its Sequelae in Women
3. Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
4. Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia
5. Clinical Interventions in Respiratory Distress Syndrome and Neonatal Lung Injury - SCOR in Lung Biology and Diseases in Infants and Children
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Phase III Randomized, Double-Blind Study of Dexamethasone vs Dexamethasone/Methylprednisolone vs Placebo for Bronchopulmonary Dysplasia
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