drugset / Trial / NCT06569251

Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone.

NCT06569251 ↗

Phase 2 Completed 68 enrolled Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
RandomizedParallel-groupSingle-blindTreatment

Summary

Respiratory morbidity, including respiratory distress syndrome (RDS), is a serious complication of preterm birth and the leading cause of early neonatal mortality and disability. The effects of antenatal corticosteroid administration on fetal lung maturation have been widely studied in order to counteract such adverse perinatal outcomes of preterm birth. The dexamethasone regimen will be evaluated at different administration frequencies, but at the same total dose. The hypothesis is: The type of dexamethasone regimen administered for fetal lung maturation influences the incidence of perinatal complications.

Timeline

Start
2024-03-01
Primary completion
2024-11-24
Completion
2024-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 6 mg Intramuscular
Subject Dexamethasone Small molecule 12 mg Intramuscular