Respiratory Distress Syndrome Clinical Trial
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 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | April 2005 |
Est. primary completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stony Brook University Hospital | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | Stony Brook University |
United States,
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 |
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