Inhaled Ciclesonide Study in Preterm Infants

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called inhaled ciclesonide in preterm infants who have a condition known as bronchopulmonary dysplasia (BPD), which affects their lungs. Researchers want to see how well this medication works and if it causes any side effects, particularly concerning its absorption and effects on blood cells. The trial is not yet recruiting participants, but when it begins, it will focus on infants who are between 8 and 28 days old and have been born very early (between 23 and 29 weeks of pregnancy) and need help breathing through a tube.

To participate, infants must not have severe birth defects or life-threatening illnesses, and they should not be suffering from certain conditions like serious infections or brain bleeding. If your baby meets these criteria, they may be eligible to join the study. Those who take part will receive the medication and will be monitored closely for any reactions or changes in their health. This trial is important as it aims to improve treatment options for vulnerable preterm infants with lung issues.

Gender

ALL

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 28.
• Exclusion Criteria:
• • Infants with congenital anomalies
• • Infants with life-threatening illness
• • Infants with active Sepsis or necrotizing enterocolitis (NEC)
• • Grade IV interventricular hemorrhage
• • Hyperglycemia or hypertension at the time of study drug administration