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Inhaled Tobramycin in BPD - Trial NCT04560179

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.

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NCT04560179
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04560179
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Inhaled Tobramycin in BPD
Phase 1 Feasibility Trial of Inhaled Tobramycin in Preterm Infants With Bronchopulmonary Dysplasia

Study Focus

Tobramycin solution for inhalation

Interventional

drug

Sponsor & Location

Erik Allen Jensen

Children's Hospital of Philadelphia

Timeline & Enrollment

Phase 1

Jan 01, 2022

Dec 31, 2023

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 period
Congenital bronchomalacia
Bronchopneumonia, unspecified
Other congenital malformations of bronchus
Diseases of bronchus, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT04560179

Non-Device Trial