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Effect of Nebulized Epinephrine on Reducing Extubation Failure in Neonates

Effect of Nebulized Epinephrine on Reducing Extubation Failure in Neonates: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201222049802N5
Enrollment
94
Registered
2025-05-08
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal mechanical ventilation, Extubation success, Respiratory distress, Nebulized epinephrine.

Interventions

Intervention 1: Intervention group Intervention group (case): Extubation candidate neonates who meet the study entry criteria will receive nebulization immediately after extubation. A dose of 0.5 mg p

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 28 Days

Inclusion criteria

Inclusion criteria: Neonates who are candidates for extubation Duration of Intubation less than one week First etubation session Written consent from parents or legal guardians

Exclusion criteria

Exclusion criteria: Cardiac arrhythmias History of hypertension Hyperthyroidism Dilated cardiomyopathy or ischemic heart disease Congenital stenosis or structural airway abnormality Inherited metabolic diseases or neuromuscular disorders Confirmed or suspected sepsis Any stage of necrotizing entrocolitis Receiving systemic or inhaled corticosteroids

Design outcomes

Primary

MeasureTime frame
Extubation success: Need for reintubation at 24, 48, 72 hours, and up to one week after extubation. Timepoint: Extubation success: defined as the need for reintubation at 24, 48, 72 hours, and up to one week after extubation. Method of measurement: Record patient file information.

Secondary

MeasureTime frame
Duration of need for non-invasive respiratory support. Timepoint: From the time of first extubation to discharge. Method of measurement: Number of days required for non-invasive ventilation.;Mortality from any cause. Timepoint: Incidence of death from admission. Method of measurement: Physical examination.;Bronchopulmonary dysplasia. Timepoint: 36 weeks. Method of measurement: Clinical observation and chest x ray.;Cardiovascular complications (tachycardia, arrhythmia). Timepoint: From patient admission to hospital discharge. Method of measurement: Physical examination and monitoring.;Incidence of Intraventricular hemorrhage. Timepoint: From patient admission to hospital discharge. Method of measurement: Brain Sonography.;Patent ductus arteriosus requires treatment. Timepoint: From patient admission to hospital discharge. Method of measurement: Echocardiography.;Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: Count the number of hospitalization days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsghar Marzban

Zanjan University of Medical Sciences

Drmarzban@zums.ac.ir+98 24 3313 1292

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026