Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418353
• Other study ID #: 20024615
• Status: Completed
• Phase: N/A
• First received: January 2, 2007
• Last updated: January 2, 2007
• Start date: August 2002
• Est. completion date: April 2005

Study information

• Verified date: January 2007
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Intraventricular Hemorrhage
• Neonatal Mortality
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Betamethasone(Celestone soluspan) and Dexamethasone

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory distress syndrome
Primary	Intraventricular hemorrhage
Primary	Neonatal mortality
Secondary	Periventricular leukomalacia
Secondary	Necrotizing enterocolitis
Secondary	Neonatal sepsis