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Inhaled Ciclesonide Study in Preterm Infants

NCT06589245 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

DRUG

Alvesco Inhalant Product

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

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Venkatesh Sampath

    lead OTHER

Principal Investigators

  • Venkatesh Sampath, MD · Children's Mercy Hospital Kansas City

  • Venkatesh Sampath, MD · Physician-Scientist

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Days
Max Age
35 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06589245 on ClinicalTrials.gov