We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418353
First Posted: January 4, 2007
Last Update Posted: January 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stony Brook University
Information provided by:
University of Oklahoma
  Purpose
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.

Condition Intervention
Respiratory Distress Syndrome Intraventricular Hemorrhage Neonatal Mortality Drug: Betamethasone(Celestone soluspan) and Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Respiratory distress syndrome
  • Intraventricular hemorrhage
  • Neonatal mortality

Secondary Outcome Measures:
  • Periventricular leukomalacia
  • Necrotizing enterocolitis
  • Neonatal sepsis

Study Start Date: August 2002
Estimated Study Completion Date: April 2005
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418353


Locations
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 117913
Sponsors and Collaborators
University of Oklahoma
Stony Brook University
Investigators
Principal Investigator: Andrew A Elimian, M.D Stony Brook University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00418353     History of Changes
Other Study ID Numbers: 20024615
First Submitted: January 2, 2007
First Posted: January 4, 2007
Last Update Posted: January 4, 2007
Last Verified: January 2007

Keywords provided by University of Oklahoma:
Antenatal corticosteroids
Betamethasone
Dexamethasone
Premature

Additional relevant MeSH terms:
Hemorrhage
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Cerebral Hemorrhage
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Dexamethasone
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
BB 1101
Betamethasone acetate phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents


To Top