Adverse Neonatal Outcomes with a Shortened Clinical Regimen of Dexamethasone.
NCT06569251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2024-11-27
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.
Conditions
- Preterm Birth
- Distress Respiratory Syndrome
Interventions
- DRUG
-
Dexamethasone 12 mg QD
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme
- DRUG
-
Dexamethasone 6 mg BID
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme
Sponsors & Collaborators
-
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
lead OTHER
Principal Investigators
-
Ricardo A Gutierrez Ramirez, MD, MSc · Universidad Nacional Autonoma de Honduras
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2024-11-24
- Completion
- 2024-11-24
Countries
- Honduras
Study Locations
More Related Trials
-
Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
NCT00669383 ·Status: COMPLETED ·Phase: NA
-
Dexamethasone Regimens for BPD Prevention in Preterm Infants
NCT07052201 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Antenatal Corticoid Therapy for Late Preterm Babies
NCT00675246 ·Status: COMPLETED ·Phase: NA
-
Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
NCT00004840 ·Status: COMPLETED ·Phase: NA
-
Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth
NCT02793700 ·Status: COMPLETED
-
Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS
NCT06188195 ·Status: RECRUITING ·Phase: NA
-
Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants
NCT04214795 ·Status: UNKNOWN
-
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
NCT03857841 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
NCT06878703 ·Status: RECRUITING ·Phase: PHASE3
-
Late Preterm Corticosteroids and Neonatal Hypoglycemia
NCT04869709 ·Status: UNKNOWN ·Phase: PHASE4
-
Prenatal Corticosteroids and Antioxidants in Preterm Infants
NCT00791687 ·Status: COMPLETED
-
Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
NCT03562182 ·Status: UNKNOWN
-
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
NCT00623740 ·Status: COMPLETED ·Phase: PHASE3
-
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
NCT02636868 ·Status: COMPLETED ·Phase: PHASE2
-
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
NCT01222247 ·Status: COMPLETED ·Phase: PHASE3
-
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
NCT00244101 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures
NCT03010891 ·Status: COMPLETED ·Phase: NA
-
Effect of Antenatal Steroid on Pulmonary Artery Blood Flow
NCT02978976 ·Status: UNKNOWN ·Phase: PHASE4
-
Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use in Preterm Infants
NCT05455879 ·Status: COMPLETED
-
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
NCT00934843 ·Status: COMPLETED ·Phase: NA
-
Corticosteroid Use in Premature Babies and Lung Ultrasonografi Use in the Progression to Bronchopulmonary Dysplasia
NCT05621785 ·Status: UNKNOWN
-
The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
NCT02112513 ·Status: COMPLETED
-
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
NCT01579513 ·Status: COMPLETED ·Phase: NA
-
Hydrocortisone for BPD
NCT01353313 ·Status: COMPLETED ·Phase: PHASE3
-
Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
NCT05055193 ·Status: COMPLETED