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

Early Phase 1WithdrawnNCT03946891

NYU Langone Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Premature Birth Premature Infant

Interventions

Inhaled FurosemideDRUG

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.

Intravenous FurosemideDRUG

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.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 1 YearHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: days 1, 2, 3, 5, 6, and 7

Data from ClinicalTrials.gov

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