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Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

This study has been completed.
Sponsor:
Collaborator:
Stony Brook University
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00418353
First received: January 2, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Oklahoma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00418353     History of Changes
Other Study ID Numbers: 20024615
Study First Received: January 2, 2007
Last Updated: January 2, 2007
Health Authority: United States: Institutional Review Board

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
Betamethasone-17,21-dipropionate
Dexamethasone acetate
Betamethasone
Dexamethasone
Betamethasone acetate phosphate
Betamethasone sodium phosphate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013