Inhaled Ciclesonide Study in Preterm Infants
The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
Venkatesh Sampath
30 participants
Sep 16, 2025
INTERVENTIONAL
Conditions
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 neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria8
- 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.
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Interventions
Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06589245