Inhaled Ciclesonide Study for Preterm Infants
This study is looking at inhaled ciclesonide (Alvesco Inhalant Product) in preterm infants to see if it can help prevent bronchopulmonary dysplasia (BPD), a serious lung condition. Researchers want to understand the safety of ciclesonide and how it affects the body in very young infants. You might be able to join if your baby was born very prematurely (between 23 and 29 weeks gestation), is between 8 and 35 days old, and needs a breathing machine. The study will look at how many times babies have high blood sugar, changes in their growth (weight, length, head size), and high blood pressure during treatment and up to about 4 months after. This study aims to enroll 30 infants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 infants.
- What's involved
- Inhaled Alvesco will be given daily for 14 days, with doses increasing from 80mcg to 160mcg.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed through study completion, which is an average of 4 months, and through the time of discharge, also an average of 4 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Inhaled Ciclesonide Study in Preterm Infants
At a glance
Conditions
NCT06589245
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Mercy Kansas City
Kansas City, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Venkatesh Sampath, MD · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City
- Venkatesh Sampath, MD · PRINCIPAL_INVESTIGATOR · Physician-Scientist
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Number of hyperglycemia events (blood glucose >150mg/dL) during treatment.Through study completion, an average of 4 months.
Blood Glucose (BG) levels will be collected 24 hours prior to initiation of study drug and then every 12 hours after initiation of study drug for 2 weeks. BG will be monitored daily for a week after cessation of drug treatment and as per NICU protocol thereafter.
- Average change in z-scores for weight, length, and head circumference.Through the time of discharge, an average of 4 months.
Baseline weight, head circumference, and length measurements will be measured as per routine NICU standards, which is daily weights and weekly length and head circumference. Weights, lengths and weights/lengths are routinely plotted in the growth chart for each baby in the NICU, and z-scores trajectories deviations (positive or negative) derived against published reference standards for this population. We will compare the average z-score deviations for growth parameters among infants exposed to the study drug and controls unexposed to study drug.
- Number of high systolic blood pressure events defined as >95% centile for gestational age and day of life.Through the time of discharge, an average of 4 months.
Blood Pressure will be collected 48 hours prior to initiation of study drug as per NICU protocol (at least twice a day) and then every 8 hours after initiation of study drug for 2 weeks. Blood pressure will also be monitored at least daily for first two weeks after cessation of drug treatment, and as per NICU protocol till discharge (at least once a day). Blood pressure is usually monitored using appropriate BP cuff size for weights. If indwelling arterial catheters are present, then blood pressures will be measured that way.
- Number of infants who do not pass the Adrenocorticotrophic Hormone (ACTH) stimulation test.6 weeks or later after last postnatal steroid course, prior to discharge
Measured via Adrenocorticotropic Hormone (ACTH) Stimulation Test, which quantifies the increase in cortisol after ACTH administration.
- Number of episodes of bronchospasm related to inhaled ciclesonide administration.The entire duration of the study drug treatment (14 days).
The investigators will quantify any episodes of bronchospasm as evaluated by changes in oxygenation/ventilation status, auscultation for wheezes and changes in ventilator loops. This is evaluated by experienced respiratory therapists and bedside nurses.
- Number of infants who develop oral thrush that require treatment.The duration of study drug treatment (14 days).
Bedside nurses routinely evaluate for this common, mostly benign complication of prematurity. We will collect data on % of infants who develop oral thrush and % of infants that require topical treatment among infants exposed to inhaled ciclesonide and the control group.
- Compare rates of BPD and severe BPD between cases and controls.BPD and severe BPD are ascertained at 36 weeks post-menstrual age.
Investigators will collect and report data on BPD and severity on each infant in the study irrespective of whether they were treated with inhaled ciclesonide or served as a control. We will also compare rates of BPD and severe BPD among the two groups.
- Systemic Absorption of inhaled CiclesonideDay 1, 3, 7, 15 of study (during drug administration).
Investigators will measure serum levels of ciclesonide and its active metabolite, des-ciclesonide 3 hour after inhaled drug administration (based on T1/2 in prior studies in children) in peripheral blood by mass spectrometry. This will provide us information on CIC to des-CIC conversion in preterm neonates, as well correlation with doses administered. Measured in picomol/ml (pmol/mL).