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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03946891
• Other study ID #: 18-01665
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 2016
• Est. completion date: June 2023

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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).

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth
• Premature Infant

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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