- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418353
Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"
January 2, 2007 updated by: University of Oklahoma
Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants.
No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality.
Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University Hospital from August 1, 2002 through July 31, 2004.
We excluded women with clinical chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical indications, quadruplets and higher order multiple gestation and those who declined enrollment.
Consenting women were randomly allocated to one of two groups by the Pharmacy using computer generated random numbers.
The statistical analysis was performed in accordance of the intention-to-treat principle.
Student t test, Chi square and Fisher exact test were used for analysis.
A P value of < .05 was considered statistically significant.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Stony Brook, New York, United States, 117913
- Stony Brook University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women in preterm labor with intact membranes
- Women with preterm premature rupture of membranes
- Women been delivered for fetal and maternal indications
- Gestational age between 24 and 33 6/7 weeks'.
Exclusion Criteria:
- Clinical chorioamnionitis
- known major fetal structural anomalies,
- known fetal chromosomal abnormalities,
- prior antenatal steroid exposure,
- quadruplets and higher order multiple gestation
- Women who declined enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Neonatal mortality
|
Intraventricular hemorrhage
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Respiratory distress syndrome
|
Secondary Outcome Measures
Outcome Measure |
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Periventricular leukomalacia
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Necrotizing enterocolitis
|
Neonatal sepsis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew A Elimian, M.D, Stony Brook University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Study Completion
April 1, 2005
Study Registration Dates
First Submitted
January 2, 2007
First Submitted That Met QC Criteria
January 2, 2007
First Posted (Estimate)
January 4, 2007
Study Record Updates
Last Update Posted (Estimate)
January 4, 2007
Last Update Submitted That Met QC Criteria
January 2, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Hemorrhage
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Dexamethasone
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
- Betamethasone acetate phosphate
Other Study ID Numbers
- 20024615
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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