Respiratory distress.
Conditions
Interventions
Intervention 1: Intervention group: Budesonide AstraZeneca Nebulizer (500 micrograms every 12 hours) for 3 days
the first dose is administered immediately after extubation. The drug can be administered undiluted or with 2 ml of 0.9% sodium chloride solution (to bring the total volume to 4 ml). Activate the nebu
Sponsors
Zanjan University of Medical Sciences
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: Birth at less than 28 weeks of gestation Congenital defects of the respiratory or cardiac system Genetic disorders Neuromuscular disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extubation success: defined as the need for reintubation. Timepoint: At 24, 48, 72 hours, and up to one week after extubation. Method of measurement: Record patient file information.;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 until discharge from hospital. Timepoint: From the time of hospitalization to the day of death. Method of measurement: Physical examination.;Bronchopulmonary dysplasia. Timepoint: At the age of 36 weeks. Method of measurement: Clinical observation and chest x ray.;Occurrence or worsening of respiratory distress after extubation (stridor, laryngospasm, upper airway obstruction). Timepoint: Up to one week after extubation. Method of measurement: Clinical evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral candidiasis. Timepoint: From the time of first extubation to discharge. Method of measurement: Physical examination.;Germinal matrix 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.;Positive culture-proven infections. Timepoint: From patient admission to hospital discharge. Method of measurement: Laboratory results.;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
Outcome results
None listed