NCT03946891

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Accepted

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.

Conditions

• Premature Birth
• Premature Infant

Interventions

Type	Name	Description
DRUG	Inhaled Furosemide	Subjects in the A arm will receive 1 mg/kg of inhaled furosemide Q 24 hours for 3 days. This will be followed by a washout period of a day followed by 1 mg/kg of intravenous furosemide Q 24 hours for 3 days.
DRUG	Intravenous Furosemide	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 date: 2016-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2019-05-13
• Last updated: 2022-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study