NCT06589245 Inhaled Ciclesonide Study in Preterm Infants
| NCT ID | NCT06589245 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Venkatesh Sampath |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-09-16 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Viable Infants born between 23 0/7 - 29 6/7 gestation * Requiring invasive (through an endotracheal tube) mechanical ventilation * Between day of life 8 to 35. * Infants have not received dexamethasone for 120 hours * If receiving hydrocortisone, then receiving ≤ 1mg/kg/day Exclusion Criteria: * Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded. * Infants receiving DEX therapy will be excluded. * We will exclude infants who have had ≥ 1 glucose level \> 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (\>95% centile for gestational age) in the 48 hours prior to study entry. * For small for gestational age, we will exclude infants with a birthweight \< 5% centile for gestational age. * Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded. * Infants receiving or have received any dexamethasone in the prior 120 hours. * Infants receiving \>1mg/kg/day of hydrocortisone. * Infants receiving any other inhaled or systemic steroid.
Contact & Investigator
Venkatesh Sampath, MD
PRINCIPAL INVESTIGATOR
Children's Mercy Hospital Kansas City
Frequently Asked Questions
Who can join the NCT06589245 clinical trial?
This trial is open to participants of all sexes, aged 8 Days or older, up to 35 Days, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06589245 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06589245 currently recruiting?
Yes, NCT06589245 is actively recruiting participants. Contact the research team at vsampath@cmh.edu for enrollment information.
Where is the NCT06589245 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT06589245 clinical trial?
NCT06589245 is sponsored by Venkatesh Sampath. The principal investigator is Venkatesh Sampath, MD at Children's Mercy Hospital Kansas City. The trial plans to enroll 30 participants.