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

NCT ID: NCT03946891

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2023-06-30

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.

Conditions

Premature Birth; Premature Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

Inhaled Furosemide

Intervention Type: DRUG

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.

Arm B

Group Type: EXPERIMENTAL

Intravenous Furosemide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

furosemide

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).

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melodi Pirzada, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

18-01665

Identifier Type: -

Identifier Source: org_study_id