Comparison of Neonatal Outcomes With Two Dexamethasone Regimens (12 mg vs 6 mg Every 12 Hours) for Fetal Lung Maturation in Preterm Birth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Duration of Mechanical Ventilation Support
Study Overview
Brief Summary
The goal of this observational study was to compare two doses of dexamethasone given to pregnant women at risk of preterm birth. Dexamethasone is a medicine used before birth to help a baby's lungs mature.
This study looked at preterm babies born between 26 and 36 weeks of pregnancy. Researchers compared babies whose mothers received dexamethasone 12 mg every 12 hours for 48 hours with babies whose mothers received dexamethasone 6 mg every 12 hours for 48 hours.
The main questions this study aimed to answer were:
- Did the higher dose of dexamethasone help preterm babies need breathing support for a shorter time?
- Did the higher dose help shorten the babies' stay in the Neonatal Intensive Care Unit (NICU)?
- Was the higher dose as safe as the lower dose for babies and mothers?
Researchers reviewed medical records from Stella Maris Women's and Children's Hospital from January 2018 to January 2023. They looked at neonatal outcomes, including breathing support, respiratory distress syndrome, length of NICU stay, low blood sugar in babies, infection in mothers, and developmental problems at 24 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 26 Weeks to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants born to mothers with gestational age between 26 and 36 weeks
- •Infants whose mothers received antenatal dexamethasone for fetal lung maturation
- •Infants with complete medical records
- •Singleton or multiple gestations, including twins, triplets, or quadruplets
Exclusion Criteria
- •Stillbirths
- •Term infants
- •Preterm infants with known congenital anomalies
- •Preterm infants with known chromosomal abnormalities
- •Cases with preterm premature rupture of membranes
Arms & Interventions
Dexamethasone 12 mg Every 12 Hours
Intervention: Dexamethasone 12 mg Every 12 Hours (Drug)
Dexamethasone 6 mg Every 12 Hours
Intervention: Dexamethasone 6 mg Every 12 Hours (Drug)
Outcomes
Primary Outcomes
Duration of Mechanical Ventilation Support
Time Frame: From initiation of mechanical ventilation until discontinuation of mechanical ventilation, assessed up to NICU discharge or 12 weeks after birth, whichever occurred first
Number of days preterm infants required mechanical ventilation support after birth. This outcome was compared between infants whose mothers received dexamethasone 12 mg every 12 hours and infants whose mothers received dexamethasone 6 mg every 12 hours.
Secondary Outcomes
- Length of Stay in the Neonatal Intensive Care Unit (LOS-NICU)(From NICU admission until NICU discharge, assessed up to 12 weeks after birth)
- Need for Respiratory Support(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Respiratory Distress Syndrome(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Sepsis(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Necrotizing Enterocolitis(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Intraventricular Hemorrhage(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Hypoglycemia(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neurodevelopmental Disorders at 24 Months(At 24 months of age after birth)
- Maternal Infection(From first dose of antenatal dexamethasone until maternal hospital discharge, assessed up to 7 days after delivery)
Investigators
Binarwan Halim
Associate Professor
Stella Maris Women and Children Hospital