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

Early Phase 1

Withdrawn

• Conditions: Premature Infant; Premature Birth
• Interventions: Drug: Inhaled Furosemide; Drug: Intravenous Furosemide

• Registration Number: NCT03946891
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-25
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects who are born prematurely at<34 weeks of gestation
• Subjects who are at least 14days old, on Oxygen and mechanical ventilation.
• Radiologic evidence of pulmonary parenchymal disease
• The NICU medical team to start furosemide administration as a part of the routine clinical management

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Exclusion Criteria

• Subjects who have received any diuretics;IV or PO for 48 hoursbefore the study initiation
• Subjects with congenital heart disease withR-L shunts.
• Subjects with acute sepsis.
• Subjects with kidney diseasedefined by creatinine > 1mg/dl or oliguria, defined as urine output < 0.6 ml/kg/hour
• Subjects with necrotizing enterocolitis (NEC)or suspected NEC
• Subjects with congenital malformations.Subjects who are receiving steroids, or have received steroids in the last 7 days(patients need to be off steroids for at least 7 days).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Inhaled Furosemide	-
Arm B	Intravenous Furosemide	-

Primary Outcome Measures

Name	Time	Method
Daily percent change from pre-treatment FiO2 requirement measurement.	days 1, 2, 3, 5, 6, and 7	Measurements will be taken twice within a two-hour window before and after treatment as applicable. On baseline day and the washout day, two measurements will be also taken within the two-hour window to compute percent change for the day

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States