An interventional study of Dexamethasone in Bronchopulmonary Dysplasia (BPD), sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Completed at 1 site in Pakistan. Open to participants aged 8 Days and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Not applicable, Interventional, and Prevention
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.
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.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's enrollment of 93 is above the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexamethasone
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 days
Total Duration of Supplemental Oxygen Therapy
Total number of days during which an infant received supplemental oxygen.
Time frame: 20 days
Pulmonary Haemorrhage During Treatment
Number of infants who developed pulmonary haemorrhage during dexamethasone treatment.
Time frame: 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.
Time frame: 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.
Time frame: From the first dexamethasone dose through day 10.
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.
Time frame: At 36 weeks' postmenstrual age.
Plan to share: 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.
Supporting information: Study protocol
Time frame: De-identified individual participant data and selected supporting documents will be available upon request from the date this registry record is publicly posted until five years after that date.
Access criteria: Qualified researchers may request de-identified participant-level data underlying the published results and the selected supporting documents by contacting the corresponding author at mamoona_qudrat@yahoo.com. Requests should include the research question, proposed analysis, and intended use. Access will require approval by the study investigators and institution, consistency with participant consent and ethics requirements, and a data-sharing agreement where required. Direct identifiers and signed consent forms will not be shared.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Shaheed Zulfiqar Ali Bhutto Medical University