The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
Venkatesh Sampath
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).
Description
Preterm infants born before 30 weeks gestation are at increased risk of developing bronchopulmonary dysplasia (BPD), a leading cause of death and long-term pulmonary insufficiency. Both hydrocortisone and synthetic glucocorticoids (sGC) are commonly used to prevent BPD in premature infants. Clinical trials have shown that hydrocortisone targeted to infants with emerging lung disease does not prevent BPD, while inhaled sGC therapy has shown mixed efficacy in clinical trials. Dexamethasone (DEX) has been shown in clinical trials to reduce BPD rates in premature infants but is associated with sho…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
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 h…
Interventions
- DrugAlvesco Inhalant Product
Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.
Location
- Children's Mercy Kansas CityKansas City, Missouri