← Back to all trials
Completed
NCT07765329
Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies
Conditions: Premature Birth, Neonatal Hypoglycemia, Maternal Infection During Pregnancy, Neurodevelopmental Disorder of Foetus, Respiratory Distress Syndrome (RDS), Necrotizing Enterocolitis (NEC), Intraventricular Hemorrhage Neonatal, Neonatal Sepsis, Intraventricular Hemorrhage (IVH), Neonatal Respiratory Distress Syndrome
Sex: All
Ages: 26 Weeks – 36 Weeks
Healthy volunteers: No
Enrollment: 200
Sponsor: Stella Maris Women and Children Hospital
Location: RSIA Stella Maris Medan North Sumatera
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07765329). StuddyBuddy aggregates publicly available trial information.