Recruiting
Phase 1

Ciclesonide

Sponsor:

Venkatesh Sampath

Code:

NCT06589245

Conditions

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Alvesco Inhalant Product

Study Details

Brief summary:

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).

Conditions

Bronchopulmonary Dysplasia

Study ID

NCT06589245

Start date

Sep 16, 2025

Status verified date

Mar, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ciclesonide

Eligible infants will be approached by study team. Parents whose infants consent to the study drug will enter the dose-escalation part of the study. Inhaled Alvesco will be administered daily for 14 days at escalating doses 80mcg and 160mcg.

no intervention: Control

Eligible infants will be approached by study team. Parents who refuse consent to the study drug will have standard of care. These parents can accept for their infant's de-identified clinical data to be used as part of the control group.

Interventions

Alvesco Inhalant Product

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

Primary outcome measure

  • Number of hyperglycemia events (blood glucose >150mg/dL) during treatment. [ Time Frame: Through study completion, an average of 4 months. ]
  • Average change in z-scores for weight, length, and head circumference. [ Time Frame: Through the time of discharge, an average of 4 months. ]
  • 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. ]
  • 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 ]
  • Number of episodes of bronchospasm related to inhaled ciclesonide administration. [ Time Frame: The entire duration of the study drug treatment (14 days). ]
  • Number of infants who develop oral thrush that require treatment. [ Time Frame: The duration of study drug treatment (14 days). ]
  • 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. ]
  • Systemic Absorption of inhaled Ciclesonide [ Time Frame: Day 1, 3, 7, 15 of study (during drug administration). ]

Central Contacts and Locations

Central contacts

Venkatesh Sampath, MD

816-234-3596vsampath@cmh.edu

Miah R Ruffin, BA, CCRC

816-731-7443mrruffin@cmh.edu

Locations

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Venkatesh Sampath, MD

816-802-1177vsampath@cmh.edu

Mariana Theodoro, MD

816-234-3591mftheodoro@cmh.edu

More Information

Sponsor

Venkatesh Sampath

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Venkatesh Sampath on 2026-03-27.