Inhaled Ciclesonide Study in Preterm Infants

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Venkatesh Sampath
Study ID
NCT06589245
Phase
PHASE1
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia

Eligibility Criteria

Sex
ALL
Age
8 Days - 35 Days
Healthy Volunteers
Not accepted

Interventions

  • Alvesco Inhalant Product — DRUG
    Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.

Study Details

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).

Key Dates

Start date
Sep 16, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Number of hyperglycemia events (blood glucose >150mg/dL) during treatment. [ Time Frame: Through study completion, an average of 4 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy Kansas CityKansas CityMissouri64108
Venkatesh Sampath, MD
[email protected]
816-802-1177
Mariana Theodoro, MD
[email protected]
816-234-3591

Find similar trials in Kansas City, MO

By research site
Children's Mercy Kansas City· Kansas City, MO

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