Inhaled Ciclesonide Study in Preterm Infants
ConditionBronchopulmonary Dysplasia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age8-35
SponsorVenkatesh Sampath
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Alvesco Inhalant Product
DrugInhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: CiclesonideExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of hyperglycemia events (blood glucose >150mg/dL) during treatment.
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.
Time frame
Through study completion, an average of 4 months.2
Average change in z-scores for weight, length, and head circumference.
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.
Time frame
Through the time of discharge, an average of 4 months.3
Number of high systolic blood pressure events defined as >95% centile for gestational age and day of life.
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.
Time frame
Through the time of discharge, an average of 4 months.4
Number of infants who do not pass the Adrenocorticotrophic Hormone (ACTH) stimulation test.
Measured via Adrenocorticotropic Hormone (ACTH) Stimulation Test, which quantifies the increase in cortisol after ACTH administration.
Time frame
6 weeks or later after last postnatal steroid course, prior to dischargeSecondary outcomes
1
Compare rates of extubation success between infants exposed to study drug and controls receiving standard NICU clinical care
Investigators will compare the rates of extubation (weaning from invasive endotracheal tube-delivered mechanical ventilation to nasal respiratory support) between infants receiving study drug and controls not receiving study drug. Successful extubation will be considered as staying extubated for 72 hours.
Time frame
Extubation rates will be calculated from the day of study drug initiation to 7 days after cessation of study drug, i.e., a 21 day window.2
Assess changes in lung injury and need in mechanical ventilation support.
Lung injury is difficult to characterize in preterm neonates. The pulmonary severity score that combines level and type of support (high frequency oscillator vs. conventional ventilator), oxygen requirements and respiratory drug therapy to calculate a score is accepted as a measure of lung injury and lung disease severity in this population. We will measure pulmonary severity scores to assess lung injury and lung disease severity. Temporal trends will assess whether PSS decreased after initiation of CIC therapy. Higher score indicate a worse outcome. PSS scores range between 0.21 to 2.95
Time frame
Baseline, and daily from study drug initiation to 1 week after study drug cessation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Venkatesh Sampath
Lead sponsor
Children's Mercy Hospital Kansas City
Sponsor institution
University of Pittsburgh
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov