Inhaled ciclesonide for preterm infants at risk of lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and systemic absorption of inhaled ciclesonide in preterm infants born before 30 weeks gestation, who are at high risk for bronchopulmonary dysplasia (BPD). It will assess the acute and intermediate toxic effects of ciclesonide compared to traditional glucocorticoids like dexamethasone, which have known adverse effects. The study will involve infants requiring mechanical ventilation and will measure the drug's bioactivity in blood cells. The goal is to find a safer glucocorticoid therapy that effectively prevents BPD without serious side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Mercy Kansas City
  Kansas City, Missouri, United States Recruiting

Study contacts

• Principal investigator: Venkatesh Sampath, MD — Children's Mercy Hospital Kansas City
• Study coordinator: Venkatesh Sampath, MD
• Email: vsampath@cmh.edu
• Phone: 816-234-3596

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.