Premature Birth, Premature Infant
Conditions
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.
Interventions
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.
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily percent change from pre-treatment FiO2 requirement measurement. | days 1, 2, 3, 5, 6, and 7 | 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 |
Countries
United States
Outcome results
None listed