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

NYU Langone Health

Status and phase

Withdrawn

Early Phase 1

Conditions

Premature Infant

Premature Birth

Treatments

Drug: Inhaled Furosemide

Drug: Intravenous Furosemide

Study type

Interventional

Funder types

Other

Identifiers

NCT03946891

18-01665

Details and patient eligibility

About

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.

Sex

All

Ages

Under 1 year old

Volunteers

Accepts Healthy Volunteers

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).