Inhaled ciclesonide for preterm infants at risk of lung disease
The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
This study is testing if inhaled ciclesonide is a safer option than traditional treatments for preventing lung disease in preterm infants born before 30 weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Days to 35 Days |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06589245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are viable infants born between 23 0/7 and 29 6/7 weeks gestation who require invasive mechanical ventilation.
Not a fit: Patients with congenital anomalies, life-threatening illnesses, or active infections such as sepsis or necrotizing enterocolitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer alternative to current glucocorticoid therapies for preventing BPD in preterm infants.
How similar studies have performed: While other studies have explored glucocorticoid therapies for BPD, the specific use of inhaled ciclesonide in this population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kansas City, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.