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NCT04560179

Inhaled Tobramycin in BPD

Phase 1 Feasibility Trial of Inhaled Tobramycin in Preterm Infants With Bronchopulmonary Dysplasia
Erik Allen Jensen·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Bronchopulmonary Dysplasia
Drug/Device/Intervention
Tobramycin solution for inhalation
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Erik Allen Jensen
Funder
Children's Hospital of Philadelphia
Timeline & enrollment
Phase
Phase 1
Start date
Jan 01, 2022
End date
Dec 31, 2023
Enrollment
54 participants
Primary outcome

Composite safety endpoint

Summary

This study is an open-label, phase 1, inter-patient dose escalation feasibility trial seeking
 establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different
 doses of inhaled tobramycin administered to very preterm infants with BPD who are receiving
 invasive mechanical ventilation and have a pathogenic Gram-negative organism detected by
 tracheal aspirate culture.

ICD-10 classifications
Bronchopulmonary dysplasia originating in the perinatal periodCongenital bronchomalaciaBronchopneumonia, unspecifiedOther congenital malformations of bronchusDiseases of bronchus, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04560179
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04560179 through Pure Global AI's free database. This Phase 1 trial is sponsored by Erik Allen Jensen and is currently Not yet recruiting. The study focuses on Bronchopulmonary Dysplasia. Target enrollment is 54 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.