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
Qualifiers
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
Treatments tested in this trial
- Alvesco Inhalant Product
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
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