To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210607051507N4

Enrollment

112

Registered

2021-11-17

Start date

2021-11-22

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care. Failed or difficult intubation

Interventions

Intervention 1: Intervention group: 0.5 cc per kg L-epinephrine 1/10000 were used as every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Premature infants with intubation for more than 3 days in the neonatal intensive care unit of Shariati Hospital in Tehran

Exclusion criteria

Exclusion criteria: Chronic lung disease Chronic heart disease nerve disease infants with a genetic and syndromic disease term infants over 34 weeks and weighing less than 1700 grams.

Design outcomes

Primary

Measure	Time frame
Pco2 in ABG. Timepoint: Six hours after extubation in the target group and placebo. Method of measurement: ABG.;FIO2 percent. Timepoint: 24 hours after the start of epinephrine or stilled water after extubation. Method of measurement: Record of ventilator.;High blood pressure. Timepoint: 24 hours after extubation. Method of measurement: Pressure control machine.;Tachycardia (a heart rate above 180 beats per minute in the baby). Timepoint: 24 hours after extubation. Method of measurement: cardiac monitoring.;Tachypnea ( the number of breaths above 60 per minute in the baby). Timepoint: 24 hours after extubation. Method of measurement: Counted by the nurse and recorded in the file.;Surfactant requirement. Timepoint: During hospitalization. Method of measurement: Extraction from the patient file.;Death. Timepoint: During hospitalization. Method of measurement: Extraction of patient file.;Reintubation after extubation failure. Timepoint: During hospitalization. Method of measurement: Extract from the file.;Intubation time. Timepoint: Hospitalization duration. Method of measurement: Extract from file.;Duration of mechanical ventilation. Timepoint: Duration of mechanical ventilation. Method of measurement: Extract from file.;The age of the baby at the time of intubation. Timepoint: The age of the baby at the time of intubation. Method of measurement: Extract of file.;Gender of the baby. Timepoint: In hospitalization. Method of measurement: Extract from file.;Gestational age. Timepoint: Hospitalization. Method of measurement: Extract from file.	—

Measure

Time frame

Pco2 in ABG. Timepoint: Six hours after extubation in the target group and placebo. Method of measurement: ABG.;FIO2 percent. Timepoint: 24 hours after the start of epinephrine or stilled water after extubation. Method of measurement: Record of ventilator.;High blood pressure. Timepoint: 24 hours after extubation. Method of measurement: Pressure control machine.;Tachycardia (a heart rate above 180 beats per minute in the baby). Timepoint: 24 hours after extubation. Method of measurement: cardiac monitoring.;Tachypnea ( the number of breaths above 60 per minute in the baby). Timepoint: 24 hours after extubation. Method of measurement: Counted by the nurse and recorded in the file.;Surfactant requirement. Timepoint: During hospitalization. Method of measurement: Extraction from the patient file.;Death. Timepoint: During hospitalization. Method of measurement: Extraction of patient file.;Reintubation after extubation failure. Timepoint: During hospitalization. Method of measurement: Extract from the file.;Intubation time. Timepoint: Hospitalization duration. Method of measurement: Extract from file.;Duration of mechanical ventilation. Timepoint: Duration of mechanical ventilation. Method of measurement: Extract from file.;The age of the baby at the time of intubation. Timepoint: The age of the baby at the time of intubation. Method of measurement: Extract of file.;Gender of the baby. Timepoint: In hospitalization. Method of measurement: Extract from file.;Gestational age. Timepoint: Hospitalization. Method of measurement: Extract from file.

—

Secondary

Measure	Time frame
Duration of non-invasive mechanical ventilation such as NIPPV.NCPAP after extubation. Timepoint: After extubation. Method of measurement: Extract from file.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmeneh Lamsehchi

Tehran University of Medical Sciences

lamsehchila@gmail.com+98 21 8163 3102

Outcome results

None listed

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