Effect of nebulized Salbutamol versus Epinephrine in treatment of transient tachypnea of neonates

The effect of nebulized Salbutamol versus nebulized Epinephrine in treatment of transient tachypnea of neonates in neonatal intensive care unit

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221028056324N1

Enrollment

Registered

2023-09-09

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Transient Tachypnea of Neonates. Transient tachypnea of newborn

Interventions

Intervention 1: Intervention group 1: In the salbutamol group, salbutamol nebulizer will be prescribed with a dose of 0.15 mg per kilogram of body weight of infants. Intervention 2: Intervention group

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Transient tachypnea of neonates Neonatal intensive care unit

Exclusion criteria

Exclusion criteria: First minute apgar below 4 Respiratory distress syndrome caused by surfactant deficiency Congenital anomalies Syndromes of chromosomal disorders Congenital heart diseases Premature neonatal sepsis Meconium aspiration Infants with metabolic disorders

Design outcomes

Primary

Measure	Time frame
Oxygen saturation. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Noninvasive Pulse Oximeter.	—

Secondary

Measure	Time frame
Heart rate. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Physical Examination.;Respiratory rate. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Physical examination.;Fraction of Inspired Oxygen. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Pulse Oximeter.;Number of nebulizer administrations. Timepoint: During hospitalization in the neonatal intensive care unit, from admission to discharge. Method of measurement: The number of nebulizer administrations will be obtained by counting documented nebulization events in medical records and treatment charts.;Duration of NCPAP respiratory support (days). Timepoint: The total duration of nasal continuous positive airway pressure (NCPAP) respiratory support, calculated from initiation to complete discontinuation, measured in days. Method of measurement: During hospitalization in the neonatal intensive care unit, from initiation of NCPAP until complete discontinuation.;Time to first enteral feeding (hours). Timepoint: From birth until initiation of the first enteral feeding. Method of measurement: Calculated based on the recorded time of birth and the documented time of initiation of the first enteral feeding in medical records.;Time to full enteral feeding (days). Timepoint: From birth until achievement of full enteral feeding. Method of measurement: Calculated based on the recorded time of birth and the documented time at which full enteral feeding was achieved in medical records.;Duration of supplemental oxygen (days). Timepoint: During hospitalization, from initiation of oxygen therapy until complete discontinuation. Method of measurement: Calculated based on documented start and end times of oxygen therapy in the neonate’s medical records in days.;Length of hospital stay (days). Timepoint: At the time of hospital discharge. Method of measurement: Days	—

Measure

Time frame

Heart rate. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Physical Examination.;Respiratory rate. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Physical examination.;Fraction of Inspired Oxygen. Timepoint: Half an hour, one hour and four hours after nebulizer administration. Method of measurement: Pulse Oximeter.;Number of nebulizer administrations. Timepoint: During hospitalization in the neonatal intensive care unit, from admission to discharge. Method of measurement: The number of nebulizer administrations will be obtained by counting documented nebulization events in medical records and treatment charts.;Duration of NCPAP respiratory support (days). Timepoint: The total duration of nasal continuous positive airway pressure (NCPAP) respiratory support, calculated from initiation to complete discontinuation, measured in days. Method of measurement: During hospitalization in the neonatal intensive care unit, from initiation of NCPAP until complete discontinuation.;Time to first enteral feeding (hours). Timepoint: From birth until initiation of the first enteral feeding. Method of measurement: Calculated based on the recorded time of birth and the documented time of initiation of the first enteral feeding in medical records.;Time to full enteral feeding (days). Timepoint: From birth until achievement of full enteral feeding. Method of measurement: Calculated based on the recorded time of birth and the documented time at which full enteral feeding was achieved in medical records.;Duration of supplemental oxygen (days). Timepoint: During hospitalization, from initiation of oxygen therapy until complete discontinuation. Method of measurement: Calculated based on documented start and end times of oxygen therapy in the neonate’s medical records in days.;Length of hospital stay (days). Timepoint: At the time of hospital discharge. Method of measurement: Days

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazila Khanzadeh

Tabriz University of Medical Sciences

Lotfalinezhadm@gmail.com+98 41 3386 0108

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026