Inhaled Ciclesonide Study in Preterm Infants

Recruiting Phase 1 Interventional Study
Bronchopulmonary Dysplasia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
8 Days – 35 Days
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
30 (estimated)
Sponsor
Venkatesh Sampath · Other
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About This Trial

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).

Trial Locations
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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 E…
Contacts

Venkatesh Sampath, MD

816-234-3596

vsampath@cmh.edu

CONTACT

Miah R Ruffin, BA, CCRC

816-731-7443

mrruffin@cmh.edu

CONTACT