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

NCT07765329 | Completed

• 1 other identifier: 170/DIR/RSIA.SM/VI/2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Antenatal Corticosteroids; Prematurity; Dexamethasone; Neonatal Outcome; Maternal Outcome

Outcome Measures

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.

  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 (9)

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

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

• Need for Respiratory Support

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

• Neonatal Respiratory Distress Syndrome

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

• Neonatal Sepsis

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

• Necrotizing Enterocolitis

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

Study Arms (2)

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

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.

Also known as: Antenatal Dexamethasone, Antenatal Corticosteroid

Dexamethasone 12 mg Every 12 Hours

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.

Also known as: Antenatal Dexamethasone, Antenatal Corticosteroid

Dexamethasone 6 mg Every 12 Hours

Eligibility Criteria

• Age: 26 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stella Maris Women and Children Hospital: lead
• Universitas Sumatera Utara: collaborator

Study Sites (1)

RSIA Stella Maris

Medan, North Sumatera, 20152, Indonesia

Location

MeSH Terms

Conditions

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

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Premature, Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 14, 2026
• Study Start: January 1, 2018
• Primary Completion: January 31, 2023
• Study Completion: June 1, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

ID (1)