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Inhaled Ciclesonide Study in Preterm Infants

RecruitingPhase 1

The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia

Who can join

8 Days – 35 Days · All sexes

Full 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

Exclusion Criteria:

* 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.

About the study

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).

What is being tested

Sponsor: Venkatesh Sampath · Participants: 30 · Started: Sep 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06589245

Locations in the U.S.

MissouriChildren's Mercy Kansas City, Kansas City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.