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CompletedNCT07765329Updated Aug 14, 2026

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

An observational study in Premature Birth, Neonatal Hypoglycemia and Maternal Infection During Pregnancy, sponsored by Stella Maris Women and Children Hospital. Completed at 1 site in Indonesia. Open to participants aged 26 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Stella Maris Women and Children Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
26 Weeks to 36 Weeks
Sex
All
01

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.

02

Conditions studied

  • 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

Keywords

  • Antenatal Corticosteroids
  • Prematurity
  • Dexamethasone
  • Neonatal Outcome
  • Maternal Outcome
03

Who can participate

Ages eligible
26 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Preterm infants treated at the Neonatal Intensive Care Unit of Stella Maris Women's and Children's Hospital, Medan, Indonesia, from January 2018 to January 2023. Data were obtained retrospectively from hospital medical records.

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

Exclusion Criteria:

  • Stillbirths
  • Term infants
  • Preterm infants with known congenital anomalies
  • Preterm infants with known chromosomal abnormalities
  • Cases with preterm premature rupture of membranes
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Dexamethasone 12 mg Every 12 Hours

    Drug: Dexamethasone 12 mg Every 12 Hours

  • Dexamethasone 6 mg Every 12 Hours

    Drug: Dexamethasone 6 mg Every 12 Hours

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.

    Also known as: Antenatal Dexamethasone, Antenatal Corticosteroid

  • 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.

    Also known as: Antenatal Dexamethasone, Antenatal Corticosteroid

05

What researchers measure

Primary outcomes

  1. Duration of Mechanical Ventilation Support

    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.

    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

Secondary outcomes

  1. Length of Stay in the Neonatal Intensive Care Unit (LOS-NICU)

    Number of days the infant stayed in the Neonatal Intensive Care Unit, also called the NICU.

    Time frame: From NICU admission until NICU discharge, assessed up to 12 weeks after birth

  2. Need for Respiratory Support

    Number of infants who required respiratory support after birth, including mechanical ventilation, continuous positive airway pressure, or nasal cannula.

    Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth

  3. Neonatal Respiratory Distress Syndrome

    Number of infants diagnosed with neonatal respiratory distress syndrome after birth.

    Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth

  4. Neonatal Sepsis

    Number of infants diagnosed with neonatal sepsis.

    Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth

  5. Necrotizing Enterocolitis

    Number of infants diagnosed with necrotizing enterocolitis.

    Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth

  6. Neonatal Intraventricular Hemorrhage

    Number of infants diagnosed with intraventricular hemorrhage.

    Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth

  7. Neonatal Hypoglycemia

    Number of infants diagnosed with low blood sugar after birth.

    Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth

  8. Neurodevelopmental Disorders at 24 Months

    Number of infants with neurodevelopmental disorders identified at 24 months of age.

    Time frame: At 24 months of age after birth

  9. Maternal Infection

    Number of mothers diagnosed with infection after receiving antenatal dexamethasone.

    Time frame: From first dose of antenatal dexamethasone until maternal hospital discharge, assessed up to 7 days after delivery

06

Study locations

1 site
  • RSIA Stella Maris
    Medan, North Sumatera 20152, Indonesia
07

Registry details

Key details

Study ID
NCT07765329
Lead sponsor
Stella Maris Women and Children Hospital
Collaborators
Universitas Sumatera Utara
Responsible party
Binarwan Halim (Associate Professor, Stella Maris Women and Children Hospital) — Principal investigator
First posted
Aug 14, 2026
Start date
Jan 1, 2018
Primary completion
Jan 31, 2023
Completion
Jun 1, 2026
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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