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New treatment option for Bronchopulmonary Dysplasia
Official title Inhaled Ciclesonide Study in Preterm Infants
ClinicalTrials.gov ID: NCT06589245
What this study is testing
What is Alvesco Inhalant Product?
Alvesco Inhalant Product is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for bronchopulmonary dysplasia.
Also referred to as ciclesonide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 35
You may be able to join if
- 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
- If receiving hydrocortisone, then receiving ≤ 1mg/kg/day
You likely can't join if
- 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...
- For small for gestational age, we will exclude infants with a birthweight \< 5% centile for gestational age.
- Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.
- Infants receiving or have received any dexamethasone in the prior 120 hours.
See the full eligibility 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 35.
- Infants have not received dexamethasone for 120 hours
- If receiving hydrocortisone, then receiving ≤ 1mg/kg/day
- 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...
- For small for gestational age, we will exclude infants with a birthweight \< 5% centile for gestational age.
- Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.
- Infants receiving or have received any dexamethasone in the prior 120 hours.
- Infants receiving \>1mg/kg/day of hydrocortisone.
- Infants receiving any other inhaled or systemic steroid.
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 days to 35 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.