Comparison of single dose with multiple dose antenatal Betamethasone in pretrm infant's outcome
Phase 3
- Conditions
- Respiratory distress syndrome of newborn.Disorders related to short gestation and low birth weight, not elsewhere classified
- Registration Number
- IRCT138711261689N1
- Lead Sponsor
- Mazandaran University of Medical Sciences and Health Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 512
Inclusion Criteria
High risk for preterm labor, gestational age between 28 weeks and 35 weeks and 6 days.
Exclusion criteria: PROM prior to randomization, major fetal anomaly, chorioamnionitis, systemic corticostroid use during pregnancy, insulin dependent diabetes mellitus in mother.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed to oxygen or CPAP. Timepoint: During hospital course. Method of measurement: Administration of oxygen and CPAP.;RDS. Timepoint: 28 days after birth. Method of measurement: Incidence of RDS.;Need to surfactant. Timepoint: Hospital course. Method of measurement: administration of surfactant during hospital course.;Need to mechanical ventilation. Timepoint: daily until 28 dayes after brith. Method of measurement: mechanical ventilation during hospital course.;Mortality. Timepoint: 28 dayes after brith. Method of measurement: Incidence of neonatal death.
- Secondary Outcome Measures
Name Time Method Infant's lenght. Timepoint: 72 hours after brith. Method of measurement: Centimeter.;Head circumference. Timepoint: 72 hours after brith. Method of measurement: centimeter.;Body weight. Timepoint: 72 hours after brith. Method of measurement: Balance in grams.