Antenatal Betamethasone Compared to Dexamethasone - BETACODE TRIAL

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Respiratory Distress Syndrome, Intraventricular Hemorrhage, Neonatal Mortality

Intervention / Treatment
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* Drug: Betamethasone(Celestone soluspan) and Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Betamethasone(Celestone soluspan) and Dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory distress syndrome |  |  | 
| Intraventricular hemorrhage |  |  | 
| Neonatal mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periventricular leukomalacia |  |  | 
| Necrotizing enterocolitis |  |  | 
| Neonatal sepsis |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature, Antenatal corticosteroids, Betamethasone, Dexamethasone