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NCT07765329

Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies

Sponsor: Stella Maris Women and Children Hospital

View on ClinicalTrials.gov

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.

Official title: Comparison of Neonatal Outcomes With Two Dexamethasone Regimens (12 mg vs 6 mg Every 12 Hours) for Fetal Lung Maturation in Preterm Birth

Key Details

Gender

All

Age Range

26 Weeks - 36 Weeks

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2018-01-01

Completion Date

2026-06-01

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone 12 mg Every 12 Hours

Pregnant women at risk of preterm birth received antenatal dexamethasone 12 mg every 12 hours for 48 hours for fetal lung maturation. Neonatal outcomes were compared with those of infants whose mothers received the lower-dose dexamethasone regimen.

DRUG

Dexamethasone 6 mg Every 12 Hours

Pregnant women at risk of preterm birth received antenatal dexamethasone 6 mg every 12 hours for 48 hours for fetal lung maturation. This regimen was compared with dexamethasone 12 mg every 12 hours.

Locations (1)

RSIA Stella Maris

Medan, North Sumatera, Indonesia