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Completed

NCT Number: NCT07765329

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

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.

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Key information

Conditions

Premature Birth Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Infections Inflammation Intestinal Diseases Intraventricular Hemorrhage (IVH) Intraventricular Hemorrhage Neonatal Lung Diseases Maternal Infection During Pregnancy Necrotizing Enterocolitis (NEC) Neonatal Hypoglycemia Neonatal Respiratory Distress Syndrome Neonatal SEPSIS Neurodevelopmental Disorder of Foetus Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

26 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

RSIA Stella Maris

Medan, North Sumatera, 20152, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone 12 mg Every 12 Hours

Drug

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.

Other names: Antenatal Dexamethasone, Antenatal Corticosteroid

Dexamethasone 6 mg Every 12 Hours

Drug

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.

Other names: Antenatal Dexamethasone, Antenatal Corticosteroid

Primary outcomes

  1. Duration of Mechanical Ventilation Support

    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

    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.

Secondary outcomes

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

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

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

  2. Need for Respiratory Support

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

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

  3. Neonatal Respiratory Distress Syndrome

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

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

  4. Neonatal Sepsis

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

    Number of infants diagnosed with neonatal sepsis.

  5. Necrotizing Enterocolitis

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

    Number of infants diagnosed with necrotizing enterocolitis.

  6. Neonatal Intraventricular Hemorrhage

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

    Number of infants diagnosed with intraventricular hemorrhage.

  7. Neonatal Hypoglycemia

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

    Number of infants diagnosed with low blood sugar after birth.

  8. Neurodevelopmental Disorders at 24 Months

    Time frame: At 24 months of age after birth

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

  9. Maternal Infection

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

    Number of mothers diagnosed with infection after receiving antenatal dexamethasone.

Sponsors and collaborators

Lead sponsor

Stella Maris Women and Children Hospital

Other

Collaborators

  • Universitas Sumatera Utara

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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