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

NCT03946891 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 18-01665
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  days 1, 2, 3, 5, 6, and 7

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Inhaled Furosemide

Arm B

EXPERIMENTAL

Drug: Intravenous Furosemide

Interventions

Inhaled Furosemide 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.

Also known as: furosemide

Arm A

Intravenous Furosemide 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.

Arm B

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Melodi Pirzada, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: June 1, 2016
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

US (1)