Bronchopulmonary Dysplasia (BPD)NCT07904104
Late Low-Dose Dexamethasone in Preterm Neonates Using DART Protocol
A study testing Dexamethasone in people with Bronchopulmonary Dysplasia (BPD), run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Premature babies, especially those who need breathing support for many days, are at risk of developing a long-term lung condition called bronchopulmonary dysplasia (BPD). BPD usually means that the baby still needs oxygen or breathing support around 36 weeks' postmenstrual age. Read more about this study
- Who is it for?
- Ages 8 days and older
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jun 2025to 15 Nov 2025
- Phase
- Interventional
- 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 8 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age at birth of 28-36 weeks.
- Birth weight below 2,000 grams.
- Postnatal age greater than seven days and postmenstrual age below 36 weeks at enrolment.
- Ongoing requirement for invasive and/or non-invasive ventilation with a fraction of inspired oxygen of at least 0.30.
- No meaningful reduction in respiratory support during the preceding 72 hours.
- Written informed consent from a parent or legal guardian.
Who cannot join
- Haemodynamically significant patent ductus arteriosus.
- Air-leak syndromes.
- Congenital malformations.
- Genetic or metabolic disorders.
- Previous exposure to postnatal corticosteroids.
- Necrotising enterocolitis.
- Focal intestinal perforation.
- Severe intraventricular haemorrhage on cranial ultrasonography.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children's Hospital, Pakistan Institute of Medical Sciences
Islamabad, Islamabad, 44000
About this study
Official title: Effect of Late (>7 Days) Low-Dose Dexamethasone on Ventilated Preterm Neonates to Prevent Bronchopulmonary Dysplasia: A Quasi-experimental Study
Premature babies, especially those who need breathing support for many days, are at risk of developing a long-term lung condition called bronchopulmonary dysplasia (BPD). BPD usually means that the baby still needs oxygen or breathing support around 36 weeks' postmenstrual age. This condition can make recovery longer and may affect the baby's breathing and development later in life.
This study looked at whether a low dose of dexamethasone, a steroid medicine that reduces inflammation, could help premature babies who were still dependent on a ventilator or non-invasive breathing support after the first week of life. The medicine was given using the DART protocol, which is a short, low-dose course of dexamethasone designed to help babies come off breathing support while reducing the risk of side effects.
Read more
The study was conducted in the Neonatal Intensive Care Unit (NICU) at the Children's Hospital, Pakistan Institute of Medical Sciences (PIMS), Islamabad. A total of 93 premature babies were included. All babies were more than 7 days old, born between 28 and 36 weeks of pregnancy, weighed less than 2000 grams at birth, and still needed significant breathing support. Babies with certain serious conditions, such as major congenital abnormalities, severe intestinal disease, or previous steroid exposure, were not included.
Investigators recorded each baby's oxygen requirement and ventilator pressure before and during dexamethasone treatment. They also observed whether the baby could be successfully removed from the ventilator within 10 days, how long oxygen and breathing support were needed, and whether any side effects occurred.
After treatment, babies needed less oxygen and lower ventilator pressure. The oxygen requirement decreased from 0.56 to 0.33, and mean airway pressure decreased from 12.3 to 8.9 cmH₂O. Seventy out of 93 babies, or 75.3%, were successfully extubated within 10 days. At 36 weeks' postmenstrual age, 26.9% of babies met the criteria for BPD.
The short-term side effects were manageable. Eleven babies developed temporary high blood sugar, and six developed high blood pressure; both were treated medically. No gastrointestinal perforation or steroid-related death was observed.
This study suggests that late, low-dose dexamethasone may help selected premature babies reduce breathing support and come off the ventilator earlier. However, because this was a single-arm study without a comparison group, it cannot prove that dexamethasone prevents BPD. Larger controlled studies with long-term follow-up are needed to confirm the benefits and safety of this treatment.
Read the detailed description
Bronchopulmonary dysplasia (BPD) is an important complication of prematurity, particularly among preterm neonates who require prolonged invasive or non-invasive ventilatory support. Persistent lung inflammation, oxygen exposure, and ventilator-associated injury contribute to evolving chronic lung disease in this population. Low-dose systemic dexamethasone has been used in selected ventilator-dependent preterm infants to reduce pulmonary inflammation and support weaning from respiratory support.
This study evaluated late low-dose dexamethasone administered after the first postnatal week using the Dexamethasone-Aided Respiratory Therapy (DART) protocol in ventilated preterm neonates admitted to a tertiary neonatal intensive care unit in Pakistan. The study focused on clinically relevant respiratory response during treatment, including changes in ventilatory requirements and extubation status, as well as short-term safety events and BPD status at 36 weeks' postmenstrual age. The study was designed to provide local evidence on the feasibility and clinical response associated with a standardized low-dose dexamethasone protocol in a resource-limited neonatal care setting.
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Being tested
- Dexamethasone
- Keywords
- Bronchopulmonary Dysplasia, Dexamethasone, Anti-Inflammatory Agent, DART Protocol, Infant, Premature
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Systemic dexamethasone was administered parenterally according to the DART protocol: 0.075 mg/kg per dose every 12 hours on days 1-3, 0.05 mg/kg per dose every 12 hours on days 4-6, 0.025 mg/kg per dose every 12 hours on days 7-8, and 0.01 mg/kg per dose every 12 hours on days 9-10. The planned cumulative dose was 0.89 mg/kg over 10 days. Treatment was discontinued if pulmonary haemorrhage or newly detected or worsening intraventricular haemorrhage occurred.
| Study group | Role | What they receive |
|---|---|---|
| Late Low-dose Dexamethasone | Experimental | Preterm neonates requiring ongoing invasive and/or non-invasive ventilation received systemic low-dose dexamethasone after the first seven days of postnatal life. Treatment was administered using a tapering regimen for up to 10 days. Respiratory support requirements, extubation, complications during treatment, and bronchopulmonary dysplasia status at 36 weeks' postmenstrual age were assessed. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fraction of Inspired Oxygen (FiO₂)
Change in the fraction of inspired oxygen required for respiratory support from baseline before dexamethasone initiation to treatment day 10. FiO₂ is expressed as a fraction from 0.21 to 1.00. A lower value indicates a lower supplemental oxygen requirement.
Measured: Baseline before the first dexamethasone dose and day 10 after treatment initiation.
Change in Mean Airway Pressure
Change in mean airway pressure, measured in cmH₂O, from baseline before dexamethasone initiation to treatment day 10. A lower value indicates a reduction in the airway pressure used for respiratory support.
Measured: Baseline before the first dexamethasone dose and day 10 after treatment initiation.
Successful Extubation Within 10 Days
Number of infants successfully extubated from invasive mechanical ventilation within 10 days after dexamethasone initiation.
Measured: Within 10 days after the first dexamethasone dose.
Time to Successful Extubation
Time in days from the first dexamethasone dose to successful extubation from invasive mechanical ventilation.
Measured: From dexamethasone initiation through day 10.
Total Duration of Ventilatory Support
Total number of days during which an infant received invasive mechanical ventilation and/or non-invasive ventilation.
Measured: 20 days
Total Duration of Supplemental Oxygen Therapy
Total number of days during which an infant received supplemental oxygen.
Measured: 20 days
Pulmonary Haemorrhage During Treatment
Number of infants who developed pulmonary haemorrhage during dexamethasone treatment.
Measured: From the first dexamethasone dose until treatment discontinuation or completion, up to 10 days.
Intraventricular Haemorrhage During Treatment
Number of infants with newly detected or worsening intraventricular haemorrhage during dexamethasone treatment, assessed using cranial ultrasonography.
Measured: From the first dexamethasone dose until treatment discontinuation or completion, up to 10 days.
All-cause Mortality During Treatment
Number of infants who died from any cause during the dexamethasone treatment period.
Measured: From the first dexamethasone dose through day 10.
Secondary outcomes (1)
Bronchopulmonary Dysplasia Status and Severity
Number of infants in each bronchopulmonary dysplasia category: no bronchopulmonary dysplasia, mild, moderate, or severe, classified using the National Institutes of Health criteria specified in the study protocol.
Measured: At 36 weeks' postmenstrual age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start18 Jun 2025
- Primary completion19 Sep 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, Quasi-experimental interventional study
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasar Um Min Allah, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Syeda Mamoona Qudrat, FCPS Pediatrics, Principal investigator, Benazir Bhutto Hospital, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904104
- Sponsor's protocol ID
- F.1-1/2015/ERB/SZABMU/1434
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be available from the corresponding author upon reasonable request for scientifically sound research. Requests will be reviewed for scientific merit and consistency with participant consent and institutional ethics requirements. Access will be subject to institutional approval and, where required, a data-sharing agreement. Direct identifiers will not be shared.
Publications
van de Loo M, van Kaam A, Offringa M, Doyle LW, Cooper C, Onland W. Corticosteroids for the prevention and treatment of bronchopulmonary dysplasia: an overview of systematic reviews. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD013271. doi: 10.1002/14651858.CD013271.pub2.
PubMed 38597338Ramaswamy VV, Bandyopadhyay T, Nanda D, Bandiya P, Ahmed J, Garg A, Roehr CC, Nangia S. Assessment of Postnatal Corticosteroids for the Prevention of Bronchopulmonary Dysplasia in Preterm Neonates: A Systematic Review and Network Meta-analysis. JAMA Pediatr. 2021 Jun 1;175(6):e206826. doi: 10.1001/jamapediatrics.2020.6826. Epub 2021 Jun 7.
PubMed 33720274Jensen EA, Watterberg KL. Postnatal Corticosteroids To Prevent Bronchopulmonary Dysplasia. Neoreviews. 2023 Nov 1;24(11):e691-e703. doi: 10.1542/neo.24-11-e691.
PubMed 37907402Doyle LW. Postnatal Corticosteroids to Prevent or Treat Bronchopulmonary Dysplasia. Neonatology. 2021;118(2):244-251. doi: 10.1159/000515950. Epub 2021 May 11.
PubMed 33975319Qudrat SM, Riaz S, Allah NUM, Razzaq S, Akhtar HN, Jahanzaib M. Effect of Late (>7 Days) Low-dose Dexamethasone on Ventilated Preterm Neonates to Prevent Bronchopulmonary Dysplasia: A Quasi-experimental Study. Journal of Rawalpindi Medical College. 2026 Jun. 30;30(2):359-65. Available from: https://journalrmc.com/index.php/JRMC/article/view/3159
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Late (>7 Days) Low-Dose Dexamethasone on Ventilated Preterm Neonates to Prevent Bronchopulmonary Dysplasia: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07904104
- Acronym / sponsor ID
- F.1-1/2015/ERB/SZABMU/1434
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Keywords
- Bronchopulmonary Dysplasia, Dexamethasone, Anti-Inflammatory Agent, DART Protocol, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 29 Oct 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.
Premature babies, especially those who need breathing support for many days, are at risk of developing a long-term lung condition called bronchopulmonary dysplasia (BPD). BPD usually means that the baby still needs oxygen or breathing support around 36 weeks' postmenstrual age. This condition can make recovery longer and may affect the baby's breathing and development later in life.
This study looked at whether a low dose of dexamethasone, a steroid medicine that reduces inflammation, could help premature babies who were still dependent on a ventilator or non-invasive breathing support after the first week of life. The medicine was given using the DART protocol, which is a short, low-dose course of dexamethasone designed to help babies come off breathing support while reducing the risk of side effects.
The study was conducted in the Neonatal Intensive Care Unit (NICU) at the Children's Hospital, Pakistan Institute of Medical Sciences (PIMS), Islamabad. A total of 93 premature babies were included. All babies were more than 7 days old, born between 28 and 36 weeks of pregnancy, weighed less than 2000 grams at birth, and still needed significant breathing support. Babies with certain serious conditions, such as major congenital abnormalities, severe intestinal disease, or previous steroid exposure, were not included.
Investigators recorded each baby's oxygen requirement and ventilator pressure before and during dexamethasone treatment. They also observed whether the baby could be successfully removed from the ventilator within 10 days, how long oxygen and breathing support were needed, and whether any side effects occurred.
After treatment, babies needed less oxygen and lower ventilator pressure. The oxygen requirement decreased from 0.56 to 0.33, and mean airway pressure decreased from 12.3 to 8.9 cmH₂O. Seventy out of 93 babies, or 75.3%, were successfully extubated within 10 days. At 36 weeks' postmenstrual age, 26.9% of babies met the criteria for BPD.
The short-term side effects were manageable. Eleven babies developed temporary high blood sugar, and six developed high blood pressure; both were treated medically. No gastrointestinal perforation or steroid-related death was observed.
This study suggests that late, low-dose dexamethasone may help selected premature babies reduce breathing support and come off the ventilator earlier. However, because this was a single-arm study without a comparison group, it cannot prove that dexamethasone prevents BPD. Larger controlled studies with long-term follow-up are needed to confirm the benefits and safety of this treatment.
Detailed description
Bronchopulmonary dysplasia (BPD) is an important complication of prematurity, particularly among preterm neonates who require prolonged invasive or non-invasive ventilatory support. Persistent lung inflammation, oxygen exposure, and ventilator-associated injury contribute to evolving chronic lung disease in this population. Low-dose systemic dexamethasone has been used in selected ventilator-dependent preterm infants to reduce pulmonary inflammation and support weaning from respiratory support.
This study evaluated late low-dose dexamethasone administered after the first postnatal week using the Dexamethasone-Aided Respiratory Therapy (DART) protocol in ventilated preterm neonates admitted to a tertiary neonatal intensive care unit in Pakistan. The study focused on clinically relevant respiratory response during treatment, including changes in ventilatory requirements and extubation status, as well as short-term safety events and BPD status at 36 weeks' postmenstrual age. The study was designed to provide local evidence on the feasibility and clinical response associated with a standardized low-dose dexamethasone protocol in a resource-limited neonatal care setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, Quasi-experimental interventional study
| Arm | Type | Receives |
|---|---|---|
| Late Low-dose Dexamethasone | Experimental | Drug: DexamethasonePreterm neonates requiring ongoing invasive and/or non-invasive ventilation received systemic low-dose dexamethasone after the first seven days of postnatal life. Treatment was administered using a tapering regimen for up to 10 days. Respiratory support requirements, extubation, complications during treatment, and bronchopulmonary dysplasia status at 36 weeks' postmenstrual age were assessed. |
Who may qualify
- Ages
- 8 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Gestational age at birth of 28-36 weeks.
- Birth weight below 2,000 grams.
- Postnatal age greater than seven days and postmenstrual age below 36 weeks at enrolment.
- Ongoing requirement for invasive and/or non-invasive ventilation with a fraction of inspired oxygen of at least 0.30.
- No meaningful reduction in respiratory support during the preceding 72 hours.
Key exclusion criteria (8 listed)
- Haemodynamically significant patent ductus arteriosus.
- Air-leak syndromes.
- Congenital malformations.
- Genetic or metabolic disorders.
- Previous exposure to postnatal corticosteroids.
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 |
|---|---|---|
| DexamethasoneSystemic dexamethasone was administered parenterally according to the DART protocol: 0.075 mg/kg per dose every 12 hours on days 1-3, 0.05 mg/kg per dose every 12 hours on days 4-6, 0.025 mg/kg per dose every 12 hours on days 7-8, and 0.01 mg/kg per dose every 12 hours on days 9-10. The planned cumulative dose was 0.89 mg/kg over 10 days. Treatment was discontinued if pulmonary haemorrhage or newly detected or worsening intraventricular haemorrhage occurred. | Drug | Late Low-dose Dexamethasone |
Primary outcome
Change in Fraction of Inspired Oxygen (FiO₂)
Time frame: Baseline before the first dexamethasone dose and day 10 after treatment initiation.
Change in the fraction of inspired oxygen required for respiratory support from baseline before dexamethasone initiation to treatment day 10. FiO₂ is expressed as a fraction from 0.21 to 1.00. A lower value indicates a lower supplemental oxygen requirement.
Change in Mean Airway Pressure
Time frame: Baseline before the first dexamethasone dose and day 10 after treatment initiation.
Change in mean airway pressure, measured in cmH₂O, from baseline before dexamethasone initiation to treatment day 10. A lower value indicates a reduction in the airway pressure used for respiratory support.
Successful Extubation Within 10 Days
Time frame: Within 10 days after the first dexamethasone dose.
Number of infants successfully extubated from invasive mechanical ventilation within 10 days after dexamethasone initiation.
Time to Successful Extubation
Time frame: From dexamethasone initiation through day 10.
Time in days from the first dexamethasone dose to successful extubation from invasive mechanical ventilation.
Total Duration of Ventilatory Support
Time frame: 20 days
Total number of days during which an infant received invasive mechanical ventilation and/or non-invasive ventilation.
Total Duration of Supplemental Oxygen Therapy
Time frame: 20 days
Total number of days during which an infant received supplemental oxygen.
Pulmonary Haemorrhage During Treatment
Time frame: From the first dexamethasone dose until treatment discontinuation or completion, up to 10 days.
Number of infants who developed pulmonary haemorrhage during dexamethasone treatment.
Intraventricular Haemorrhage During Treatment
Time frame: From the first dexamethasone dose until treatment discontinuation or completion, up to 10 days.
Number of infants with newly detected or worsening intraventricular haemorrhage during dexamethasone treatment, assessed using cranial ultrasonography.
All-cause Mortality During Treatment
Time frame: From the first dexamethasone dose through day 10.
Number of infants who died from any cause during the dexamethasone treatment period.
1 secondary outcome
Bronchopulmonary Dysplasia Status and Severity
Time frame: At 36 weeks' postmenstrual age.
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 29 Oct 2026.
- Background: PubMed 38597338van de Loo M, van Kaam A, Offringa M, Doyle LW, Cooper C, Onland W. Corticosteroids for the prevention and treatment of bronchopulmonary dysplasia: an overview of systematic reviews. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD013271. doi: 10.1002/14651858.CD013271.pub2.
- Background: PubMed 33720274Ramaswamy VV, Bandyopadhyay T, Nanda D, Bandiya P, Ahmed J, Garg A, Roehr CC, Nangia S. Assessment of Postnatal Corticosteroids for the Prevention of Bronchopulmonary Dysplasia in Preterm Neonates: A Systematic Review and Network Meta-analysis. JAMA Pediatr. 2021 Jun 1;175(6):e206826. doi: 10.1001/jamapediatrics.2020.6826. Epub 2021 Jun 7.
- Background: PubMed 37907402Jensen EA, Watterberg KL. Postnatal Corticosteroids To Prevent Bronchopulmonary Dysplasia. Neoreviews. 2023 Nov 1;24(11):e691-e703. doi: 10.1542/neo.24-11-e691.
- Background: PubMed 33975319Doyle LW. Postnatal Corticosteroids to Prevent or Treat Bronchopulmonary Dysplasia. Neonatology. 2021;118(2):244-251. doi: 10.1159/000515950. Epub 2021 May 11.
- Results publicationQudrat SM, Riaz S, Allah NUM, Razzaq S, Akhtar HN, Jahanzaib M. Effect of Late (>7 Days) Low-dose Dexamethasone on Ventilated Preterm Neonates to Prevent Bronchopulmonary Dysplasia: A Quasi-experimental Study. Journal of Rawalpindi Medical College. 2026 Jun. 30;30(2):359-65. Available from: https://journalrmc.com/index.php/JRMC/article/view/3159
- Late (≥ 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infantsLink provided by the sponsor.
- Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be available from the corresponding author upon reasonable request for scientifically sound research. Requests will be reviewed for scientific merit and consistency with participant consent and institutional ethics requirements. Access will be subject to institutional approval and, where required, a data-sharing agreement. Direct identifiers will not be shared.
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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.
Syeda Mamoona Qudrat, FCPS Pediatrics principal investigator
Benazir Bhutto Hospital, Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Bronchopulmonary Dysplasia (BPD), run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 6 inclusion and 8 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 29 Oct 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 Pakistan. 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?
Change in Fraction of Inspired Oxygen (FiO₂) (time frame: Baseline before the first dexamethasone dose and day 10 after treatment initiation.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07904104, which also lists 5 linked publications.
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 29 Oct 2026.