Inhaled Ciclesonide Study in Preterm Infants

Recruiting now · Phase 1

Conditions studied: Bronchopulmonary Dysplasia

In brief

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 facts

Study ID

NCT06589245

Run by

Venkatesh Sampath

People needed

30

Starts

2025-09-16

Expected to finish

2026-08-31

Last updated by the study team

2026-03-27

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded.
• Infants receiving DEX therapy will be excluded.
• We will exclude infants who have had ≥ 1 glucose level > 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (>95% centile for gestational age) in the 48 hours prior to study entry.
• For small for gestational age, we will exclude infants with a birthweight < 5% centile for gestational age.
• Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.
• Infants receiving or have received any dexamethasone in the prior 120 hours.
• Infants receiving >1mg/kg/day of hydrocortisone.
• Infants receiving any other inhaled or systemic steroid.

Where it is running

• Children's Mercy Kansas City — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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