Inhaled Ciclesonide Study in Preterm Infants

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).

Conditions

Bronchopulmonary Dysplasia

Study Overview

Study Details

Study overview

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).

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

Inhaled Ciclesonide Study in Preterm Infants

Condition
Bronchopulmonary Dysplasia
Intervention / Treatment

-

Contacts and Locations

Kansas City

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

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.

For general information about clinical research, read Learn About Studies.

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 28.
  • * Infants with congenital anomalies
  • * Infants with life-threatening illness
  • * Infants with active Sepsis or necrotizing enterocolitis (NEC)
  • * Grade IV interventricular hemorrhage
  • * Hyperglycemia or hypertension at the time of study drug administration

Ages Eligible for Study

8 Days to 28 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-08-31