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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07765329
Enrollment
200
Registered
2026-08-14
Start date
2018-01-01
Completion date
2026-06-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraventricular Hemorrhage (IVH), Intraventricular Hemorrhage Neonatal, Maternal Infection During Pregnancy, Necrotizing Enterocolitis (NEC), Neonatal Hypoglycemia, Neonatal Respiratory Distress Syndrome, Neonatal Sepsis, Neurodevelopmental Disorder of Foetus, Premature Birth, Respiratory Distress Syndrome (RDS)

Keywords

Antenatal Corticosteroids, Prematurity, Dexamethasone, Neonatal Outcome, Maternal Outcome

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.

Interventions

DRUGDexamethasone 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.

DRUGDexamethasone 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.

Sponsors

Stella Maris Women and Children Hospital
Lead SponsorOTHER
Universitas Sumatera Utara
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 36 Weeks
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

Design outcomes

Primary

MeasureTime frameDescription
Duration of Mechanical Ventilation SupportFrom initiation of mechanical ventilation until discontinuation of mechanical ventilation, assessed up to NICU discharge or 12 weeks after birth, whichever occurred firstNumber 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

MeasureTime frameDescription
Length of Stay in the Neonatal Intensive Care Unit (LOS-NICU)From NICU admission until NICU discharge, assessed up to 12 weeks after birthNumber of days the infant stayed in the Neonatal Intensive Care Unit, also called the NICU.
Need for Respiratory SupportFrom birth until NICU discharge, assessed up to 12 weeks after birthNumber of infants who required respiratory support after birth, including mechanical ventilation, continuous positive airway pressure, or nasal cannula.
Neonatal Respiratory Distress SyndromeFrom birth until NICU discharge, assessed up to 12 weeks after birthNumber of infants diagnosed with neonatal respiratory distress syndrome after birth.
Neonatal SepsisFrom birth until NICU discharge, assessed up to 12 weeks after birthNumber of infants diagnosed with neonatal sepsis.
Necrotizing EnterocolitisFrom birth until NICU discharge, assessed up to 12 weeks after birthNumber of infants diagnosed with necrotizing enterocolitis.
Neonatal Intraventricular HemorrhageFrom birth until NICU discharge, assessed up to 12 weeks after birthNumber of infants diagnosed with intraventricular hemorrhage.
Neonatal HypoglycemiaFrom birth until NICU discharge, assessed up to 12 weeks after birthNumber of infants diagnosed with low blood sugar after birth.
Neurodevelopmental Disorders at 24 MonthsAt 24 months of age after birthNumber of infants with neurodevelopmental disorders identified at 24 months of age.
Maternal InfectionFrom first dose of antenatal dexamethasone until maternal hospital discharge, assessed up to 7 days after deliveryNumber of mothers diagnosed with infection after receiving antenatal dexamethasone.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026