Status:
RECRUITING
Inhaled Ciclesonide Study in Preterm Infants
Lead Sponsor:
Venkatesh Sampath
Collaborating Sponsors:
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
8-28 years
Phase:
PHASE1
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 n...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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 28.
Exclusion
- Infants with congenital anomalies
- Infants with life-threatening illness
- Infants with active Sepsis or necrotizing enterocolitis (NEC)
- Grade IV interventricular hemorrhage
- Hyperglycemia or hypertension at the time of study drug administration
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06589245
Start Date
September 16 2025
End Date
August 31 2026
Last Update
January 6 2026
Active Locations (1)
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1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108