Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A
|
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.
Other Names:
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| Experimental: Arm B
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects who are born prematurely at<34 weeks of gestation
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Subjects who are at least 14days old, on Oxygen and mechanical ventilation.
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Radiologic evidence of pulmonary parenchymal disease
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The NICU medical team to start furosemide administration as a part of the routine clinical management
Exclusion Criteria:
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Subjects who have received any diuretics;IV or PO for 48 hoursbefore the study initiation
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Subjects with congenital heart disease withR-L shunts.
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Subjects with acute sepsis.
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Subjects with kidney diseasedefined by creatinine > 1mg/dl or oliguria, defined as urine output < 0.6 ml/kg/hour
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Subjects with necrotizing enterocolitis (NEC)or suspected NEC
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Melodi Pirzada, MD, New York Langone Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-01665