RECRUITING

Inhaled Ciclesonide Study in Preterm Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia

Quick Facts

Study Start:2025-06-02
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06589245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Days to 28 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Viable Infants born between 23 0/7 - 29 6/7 gestation
  2. * Requiring invasive (through an endotracheal tube) mechanical ventilation
  3. * Between day of life 8 to 28.
  1. * Infants with congenital anomalies
  2. * Infants with life-threatening illness
  3. * Infants with active Sepsis or necrotizing enterocolitis (NEC)
  4. * Grade IV interventricular hemorrhage
  5. * Hyperglycemia or hypertension at the time of study drug administration

Contacts and Locations

Study Contact

Venkatesh Sampath, MD
CONTACT
816-234-3596
vsampath@cmh.edu
Anne M Holmes, RN, MSN,CCRC
CONTACT
816-731-7043
aholmes@cmh.edu

Principal Investigator

Venkatesh Sampath, MD
PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Venkatesh Sampath, MD
PRINCIPAL_INVESTIGATOR
Physician-Scientist

Study Locations (Sites)

Children's Mercy Kansas City
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • Venkatesh Sampath, MD, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City
  • Venkatesh Sampath, MD, PRINCIPAL_INVESTIGATOR, Physician-Scientist

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bronchopulmonary Dysplasia