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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 26 to 36 weeks
• All sexes
• No healthy volunteers
• Child

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

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

Being tested

Dexamethasone 12 mg Every 12 Hours, Dexamethasone 6 mg Every 12 Hours

Keywords

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

Medical subject headings

Premature Birth, Respiratory Distress Syndrome, Enterocolitis, Necrotizing, Neonatal Sepsis, Respiratory Distress Syndrome, Newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Dexamethasone 12 mg Every 12 HoursDrug

  Also called Antenatal Dexamethasone, Antenatal Corticosteroid

  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.

• Dexamethasone 6 mg Every 12 HoursDrug

  Also called Antenatal Dexamethasone, Antenatal Corticosteroid

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: From initiation of mechanical ventilation until discontinuation of mechanical ventilation, assessed up to NICU discharge or 12 weeks after birth, whichever occurred first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted14 Aug 2026
2. Study start1 Jan 2018
3. Primary completion31 Jan 2023
4. Study completion1 Jun 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Premature BirthStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.