The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 8 days
Maximum Age: 1 month
Healthy Volunteers: f
View:
• 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
Locations
United States
Missouri
Children's Mercy Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Venkatesh Sampath, MD
vsampath@cmh.edu
816-234-3596
Backup
Miah R Ruffin, BA, CCRC
mrruffin@cmh.edu
816-731-7443
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Ciclesonide
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.
No_intervention: Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Venkatesh Sampath