A Phase 1 interventional study of Alvesco Inhalant Product in Bronchopulmonary Dysplasia, sponsored by Venkatesh Sampath. Recruiting at 1 site in United States. Open to participants aged 8 Days to 35 Days. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Venkatesh Sampath · Phase 1, Interventional, and Prevention
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Among 147 studies in Bronchopulmonary Dysplasia with a site in United States — 30 open to participants now, 37 under way, 1 of them phase 3. Bronchopulmonary Dysplasia · United States.
Among the 147 studies in Bronchopulmonary Dysplasia with a site in United States, this one is the 76th largest by planned enrollment of the 117 interventional ones that give a count, is one of 6 that started in 2025, is one of 15 in phase 1, reaches primary completion later than 15 of the 36 other live ones, and was the 134th registered.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
Browse Bronchopulmonary Dysplasia studies →30 of the 147 studies in Bronchopulmonary Dysplasia with a site in United States are open now. Recruiting first, the newest first:
NICHD Neonatal Research Network · Sites in United States
Ages up to 31 wk
University of Alabama at Birmingham · Sites in United States
Ages 7 days–30 days
University of Alabama at Birmingham · Sites in United States
Ages 1 mo–5 mo · Healthy volunteers
University of Alabama at Birmingham · Sites in United States
Ages 1 days–3 days
Augusta University · Sites in United States
Ages 25 wk–34 wk
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 58 Bronchopulmonary Dysplasia studies recruiting now, 7 (12%) set no upper age limit and 50 (86%) stop at 75 or younger; 56 take children under 18; 11 take healthy volunteers.
This study: 8 Days to 35 Days · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
147 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 36 · Phase 3 20 · Phase 4 7
First in 1991; this study’s year is marked. 6 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Median enrollment 50 across the 117 interventional studies, 155 across the 30 observational. Of the 99 that completed or were terminated, 42 (42%) have results posted.
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11 of 147 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Venkatesh Sampath as lead sponsor.
Venkatesh Sampath has 1 study filed under Bronchopulmonary Dysplasia — fewer than ten, so there is no comparison to draw.
20 of the studies in Bronchopulmonary Dysplasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT05568264Shirley Ryan AbilityLabEffects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit | 2026-12-31 |
| NCT07447739Khang NguyenCan Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively? | 2027-03 |
Add all 20 to your calendar (.ics) → With an account.
Among the 147 studies in Bronchopulmonary Dysplasia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).
Preterm infants born before 30 weeks gestation are at increased risk of developing bronchopulmonary dysplasia (BPD), a leading cause of death and long-term pulmonary insufficiency. Both hydrocortisone and synthetic glucocorticoids (sGC) are commonly used to prevent BPD in premature infants. Clinical trials have shown that hydrocortisone targeted to infants with emerging lung disease does not prevent BPD, while inhaled sGC therapy has shown mixed efficacy in clinical trials. Dexamethasone (DEX) has been shown in clinical trials to reduce BPD rates in premature infants but is associated with short term and long-term adverse effects including cerebral palsy. There is an unmet need for efficacious Glucocorticoid (GC) therapy in premature infants to prevent BPD without encumbering serious adverse events. To address this challenge, our group has been investigating ciclesonide (CIC), a sGC pro-drug that in the inhaled form is FDA approved for use in asthma and allergic rhinitis in older children. Our published and ongoing work has shown that DEX and CIC regulate GR transcriptional targets and several genes implicated in lung protective effects in neonatal rats. Remarkably, CIC does not suppress somatic growth nor IGF-1 levels, induce hyperglycemia, or cause neuroanatomical changes in the cerebral cortex of neonatal rats, which are known pathologies caused by DEX in premature infants. Furthermore, ongoing studies reveal that CIC is as efficacious as DEX in preventing lung injury in a hyperoxia-model of experimental BPD. This study tests the hypothesis that CIC will have minimal systemic absorption and a favorable safety profile in premature infants at risk of developing BPD.
The fear of long-term neurological adverse effects has limited optimal use of sGC therapy to prevent BPD. This application is significant as it proposes to repurpose CIC, an existing sGC, for novel therapeutic use in preterm infants to prevent BPD. CIC is already FDA-approved for use in children >5 years for allergic rhinitis and asthma, and can be used on a compassionate basis down to 2 years of age. The investigators believe our study is impactful and translationally relevant as it addresses an unmet need for efficacious GC therapy to prevent BPD in premature infants without encumbering the neurological and somatic adverse effects. Successful testing of our hypothesis will pave the way for a large, multicenter randomized control trial of CIC therapy in premature infants to prevent BPD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Eligible infants will be approached by study team. Parents whose infants consent to the study drug will enter the dose-escalation part of the study. Inhaled Alvesco will be administered daily for 14 days at escalating doses 80mcg and 160mcg.
Drug: Alvesco Inhalant Product
Eligible infants will be approached by study team. Parents who refuse consent to the study drug will have standard of care. These parents can accept for their infant's de-identified clinical data to be used as part of the control group.
Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.
Also known as: ciclesonide
Number of hyperglycemia events (blood glucose >150mg/dL) during treatment.
Blood Glucose (BG) levels will be collected 24 hours prior to initiation of study drug and then every 12 hours after initiation of study drug for 2 weeks. BG will be monitored daily for a week after cessation of drug treatment and as per NICU protocol thereafter.
Time frame: Through study completion, an average of 4 months.
Average change in z-scores for weight, length, and head circumference.
Baseline weight, head circumference, and length measurements will be measured as per routine NICU standards, which is daily weights and weekly length and head circumference. Weights, lengths and weights/lengths are routinely plotted in the growth chart for each baby in the NICU, and z-scores trajectories deviations (positive or negative) derived against published reference standards for this population. We will compare the average z-score deviations for growth parameters among infants exposed to the study drug and controls unexposed to study drug.
Time frame: Through the time of discharge, an average of 4 months.
Number of high systolic blood pressure events defined as >95% centile for gestational age and day of life.
Blood Pressure will be collected 48 hours prior to initiation of study drug as per NICU protocol (at least twice a day) and then every 8 hours after initiation of study drug for 2 weeks. Blood pressure will also be monitored at least daily for first two weeks after cessation of drug treatment, and as per NICU protocol till discharge (at least once a day). Blood pressure is usually monitored using appropriate BP cuff size for weights. If indwelling arterial catheters are present, then blood pressures will be measured that way.
Time frame: Through the time of discharge, an average of 4 months.
Number of infants who do not pass the Adrenocorticotrophic Hormone (ACTH) stimulation test.
Measured via Adrenocorticotropic Hormone (ACTH) Stimulation Test, which quantifies the increase in cortisol after ACTH administration.
Time frame: 6 weeks or later after last postnatal steroid course, prior to discharge
Number of episodes of bronchospasm related to inhaled ciclesonide administration.
The investigators will quantify any episodes of bronchospasm as evaluated by changes in oxygenation/ventilation status, auscultation for wheezes and changes in ventilator loops. This is evaluated by experienced respiratory therapists and bedside nurses.
Time frame: The entire duration of the study drug treatment (14 days).
Number of infants who develop oral thrush that require treatment.
Bedside nurses routinely evaluate for this common, mostly benign complication of prematurity. We will collect data on % of infants who develop oral thrush and % of infants that require topical treatment among infants exposed to inhaled ciclesonide and the control group.
Time frame: The duration of study drug treatment (14 days).
Compare rates of BPD and severe BPD between cases and controls.
Investigators will collect and report data on BPD and severity on each infant in the study irrespective of whether they were treated with inhaled ciclesonide or served as a control. We will also compare rates of BPD and severe BPD among the two groups.
Time frame: BPD and severe BPD are ascertained at 36 weeks post-menstrual age.
Systemic Absorption of inhaled Ciclesonide
Investigators will measure serum levels of ciclesonide and its active metabolite, des-ciclesonide 3 hour after inhaled drug administration (based on T1/2 in prior studies in children) in peripheral blood by mass spectrometry. This will provide us information on CIC to des-CIC conversion in preterm neonates, as well correlation with doses administered. Measured in picomol/ml (pmol/mL).
Time frame: Day 1, 3, 7, 15 of study (during drug administration).
Compare rates of extubation success between infants exposed to study drug and controls receiving standard NICU clinical care
Investigators will compare the rates of extubation (weaning from invasive endotracheal tube-delivered mechanical ventilation to nasal respiratory support) between infants receiving study drug and controls not receiving study drug. Successful extubation will be considered as staying extubated for 72 hours.
Time frame: Extubation rates will be calculated from the day of study drug initiation to 7 days after cessation of study drug, i.e., a 21 day window.
Assess changes in lung injury and need in mechanical ventilation support.
Lung injury is difficult to characterize in preterm neonates. The pulmonary severity score that combines level and type of support (high frequency oscillator vs. conventional ventilator), oxygen requirements and respiratory drug therapy to calculate a score is accepted as a measure of lung injury and lung disease severity in this population. We will measure pulmonary severity scores to assess lung injury and lung disease severity. Temporal trends will assess whether PSS decreased after initiation of CIC therapy. Higher score indicate a worse outcome. PSS scores range between 0.21 to 2.95
Time frame: Baseline, and daily from study drug initiation to 1 week after study drug cessation.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2027, 20 months after the start.
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Studies of the drug tested here: Ciclesonide