Premature BirthNCT07765329
Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies
An observational study of Premature Birth and Neonatal Hypoglycemia, run by Stella Maris Women and Children Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 36 weeks
- Conditions the study is for
- Premature Birth, Neonatal Hypoglycemia, Maternal Infection During Pregnancy
- What is being tested?
- Dexamethasone 12 mg Every 12 Hours and Dexamethasone 6 mg Every 12 Hours
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2018to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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.
Who may be able to join
- 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
Who cannot join
- Stillbirths
- Term infants
- Preterm infants with known congenital anomalies
- Preterm infants with known chromosomal abnormalities
- Cases with preterm premature rupture of membranes
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
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.
Read more
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)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 12 mg Every 12 Hours | Not described Receives: Drug: Dexamethasone 12 mg Every 12 Hours | |
| Dexamethasone 6 mg Every 12 Hours | Not described Receives: Drug: Dexamethasone 6 mg Every 12 Hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (9)
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.
Measured: From NICU admission until NICU discharge, assessed up to 12 weeks after birth
Need for Respiratory Support
Number of infants who required respiratory support after birth, including mechanical ventilation, continuous positive airway pressure, or nasal cannula.
Measured: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Respiratory Distress Syndrome
Number of infants diagnosed with neonatal respiratory distress syndrome after birth.
Measured: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Sepsis
Number of infants diagnosed with neonatal sepsis.
Measured: From birth until NICU discharge, assessed up to 12 weeks after birth
Necrotizing Enterocolitis
Number of infants diagnosed with necrotizing enterocolitis.
Measured: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Intraventricular Hemorrhage
Number of infants diagnosed with intraventricular hemorrhage.
Measured: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Hypoglycemia
Number of infants diagnosed with low blood sugar after birth.
Measured: From birth until NICU discharge, assessed up to 12 weeks after birth
Neurodevelopmental Disorders at 24 Months
Number of infants with neurodevelopmental disorders identified at 24 months of age.
Measured: At 24 months of age after birth
Maternal Infection
Number of mothers diagnosed with infection after receiving antenatal dexamethasone.
Measured: From first dose of antenatal dexamethasone until maternal hospital discharge, assessed up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jan 2018
- Primary completion31 Jan 2023
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stella Maris Women and Children Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Sumatera Utara
- Responsible party
- Principal investigator, Binarwan Halim, Stella Maris Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765329
- Sponsor's protocol ID
- 170/DIR/RSIA.SM/VI/2024
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07765329
- Acronym / sponsor ID
- 170/DIR/RSIA.SM/VI/2024
- Conditions
- Premature Birth, Neonatal Hypoglycemia, Maternal Infection During Pregnancy, Neurodevelopmental Disorder of Foetus, Respiratory Distress Syndrome (RDS), Necrotizing Enterocolitis (NEC)
- Keywords
- Antenatal Corticosteroids, Prematurity, Dexamethasone, Neonatal Outcome, Maternal Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stella Maris Women and Children HospitalUniversity, hospital or other
- Collaborators
- Universitas Sumatera Utara
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 26 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Stillbirths
- Term infants
- Preterm infants with known congenital anomalies
- Preterm infants with known chromosomal abnormalities
- Cases with preterm premature rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 12 mg Every 12 HoursAlso: Antenatal Dexamethasone, Antenatal CorticosteroidPregnant 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 12 mg Every 12 Hours |
| Dexamethasone 6 mg Every 12 HoursAlso: Antenatal Dexamethasone, Antenatal CorticosteroidPregnant 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. | Drug | Dexamethasone 6 mg Every 12 Hours |
Primary outcome
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.
9 secondary outcomes
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
Need for Respiratory Support
Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Respiratory Distress Syndrome
Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Sepsis
Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth
Necrotizing Enterocolitis
Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Intraventricular Hemorrhage
Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth
Neonatal Hypoglycemia
Time frame: From birth until NICU discharge, assessed up to 12 weeks after birth
Neurodevelopmental Disorders at 24 Months
Time frame: At 24 months of age after birth
Maternal Infection
Time frame: From first dose of antenatal dexamethasone until maternal hospital discharge, assessed up to 7 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Neonatal Hypoglycemia, run by Stella Maris Women and Children Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.