drugset / Trial / NCT03946891

Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety

NCT03946891

Phase 0 Withdrawn NYU Langone Health
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective,randomized, cross over study comparing the efficacy and safety of nebulizedfurosemide with Intra Venous (IV)furosemide in preterm infants who areventilator-and oxygen dependent. Reviewing the patient census on Neo data by the Sub Investigator will identify the potential subjects. Subject will be randomized to either A arm or B arm. Subjects in the A arm will receive 1 mg/kg of inhaled furosemideQ 24 hours for 3 days. This will be followed by a washout period of a day followed by 1mg/kg of intravenous furosemide Q 24 hours for 3 days. Subjects in the B arm will receive 1 mg/kg of intravenous furosemide Q 24 hours for 3 days followed by a washout period, which is then followed by 1 mg/kg of inhaled furosemide Q 24 hours for 3 days.

Timeline

Start
2016-06
Primary completion
2023-06
Completion
2023-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified 1 mg/kg Inhaled

Indications