Actively Recruiting
Inhaled Ciclesonide Study in Preterm Infants
Led by Venkatesh Sampath · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
Sponsors
V
Venkatesh Sampath
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Inhaled Ciclesonide Study in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Viable infants born between 23 0/7 and 29 6/7 weeks gestation
- Requiring invasive mechanical ventilation through an endotracheal tube
- Between 8 and 35 days of age
- Have not received dexamethasone in the last 120 hours
- If receiving hydrocortisone, dose must be 1 mg/kg/day or less
You will not qualify if you...
- Major congenital lung or other organ anomalies
- Life-threatening illness
- Active sepsis or necrotizing enterocolitis (NEC)
- Grade IV hemorrhage
- Receiving dexamethasone therapy
- Had one or more glucose measurements over 150 mg/dL in the 24 hours before study entry
- On insulin therapy for hyperglycemia
- Hypertension above the 95th percentile for gestational age in the 48 hours before study entry
- Birthweight less than the 5th percentile for gestational age (small for gestational age)
- Recent pulmonary hemorrhage within 72 hours before study entry
- Receiving more than 1 mg/kg/day of hydrocortisone
- Receiving any other inhaled or systemic steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
V
Venkatesh Sampath, MD
CONTACT
M
Miah R Ruffin, BA, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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