Inhaled Ciclesonide Study in Preterm Infants

DRUG

Alvesco Inhalant Product

Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.

Number of hyperglycemia events (blood glucose >150mg/dL) during treatment.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 Ciclesonide

Time frame: Day 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).

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.