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

NCT07765329 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-08-14

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Universitas Sumatera Utara

    collaborator OTHER

  • Stella Maris Women and Children Hospital

    lead OTHER

Eligibility

Min Age
26 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-01-31
Completion
2026-06-01

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765329 on ClinicalTrials.gov