Back to resultsNebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
Primary Purpose
Premature Birth, Premature Infant
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inhaled Furosemide
Intravenous Furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth
Eligibility Criteria
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
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).
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Outcomes
Primary Outcome Measures
Daily percent change from pre-treatment FiO2 requirement measurement.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03946891
Brief Title
Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
Official Title
Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped due to lack of study staff and inability to enroll subjects into the study due to restrictive inclusion criteria.
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Premature Infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Inhaled Furosemide
Other Intervention Name(s)
furosemide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous Furosemide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily percent change from pre-treatment FiO2 requirement measurement.
Description
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
Time Frame
days 1, 2, 3, 5, 6, and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melodi Pirzada, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
We'll reach out to this number within 24 hrs