The effect of inhaled Salbutamol on improvement of newborns with Respiratory distress syndrome

The effect of inhaled Salbutamol (Ventolin) before intratracheal surfactant on the outcomes of Respiratory distress syndrome of newborn

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200805048312N1

Enrollment

Registered

2020-10-28

Start date

2020-10-22

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: nebulizzing single dose of inhalational salbutamol (asthalin®) from Cipla (india) , 30 minute before injection of intratracheal surfactant. dosage : 0.2 mg per kg.

Eligibility

Sex/Gender

All

Age

1 Days to No maximum

Inclusion criteria

Inclusion criteria: Informed parent's consent Diagnosis of respiratory distress syndrome due to clinical and Para clinical data and candidation of interatrachial surfactant injection

Exclusion criteria

Exclusion criteria: Other respiratory disease such as Transient tachypnea of newborn, meconium aspiration,pneumonitis, congenital diaphragmatic hernia Arrhythmia, heart rate more than 180 5th minute respiratory apgar under 3 Congenital heart malformation, chromosomal malformation Asphyxia, severe hypoxia Birth trauma Hydrops Twin to twin transfusion Sepsis Severe Metabolic acidosis Electrolyte disorder, hypoglycemia, polycytemia History of maternal diabetes or asthma Death in first day of life Congenital tumors

Design outcomes

Primary

Measure	Time frame
Oxygen saturation (%). Timepoint: at time of nebulizing of salbutamol and 30 minute after injection of intratracheal surfactant. Method of measurement: Pulse oxymetry.;Arterial partial pressure of CO2 (PaCO2 ). Timepoint: at time of nebulizing of salbutamol and 30 minute after injection of intratracheal surfactant. Method of measurement: ABG test (Artrial blood gas).	—

Secondary

Measure	Time frame
Length of hospitalization (days). Timepoint: at the time of discharging. Method of measurement: Patient file.;Need for mechanical ventilation (duration). Timepoint: at the time of extubation. Method of measurement: Patient file.;Need for continuous positive airway pressure (CPAP). Timepoint: at the time af discontinuing of CPAP. Method of measurement: Patient file.;Outcome (death or live). Timepoint: at the time of discharging. Method of measurement: Patient file.	—

Measure

Time frame

Length of hospitalization (days). Timepoint: at the time of discharging. Method of measurement: Patient file.;Need for mechanical ventilation (duration). Timepoint: at the time of extubation. Method of measurement: Patient file.;Need for continuous positive airway pressure (CPAP). Timepoint: at the time af discontinuing of CPAP. Method of measurement: Patient file.;Outcome (death or live). Timepoint: at the time of discharging. Method of measurement: Patient file.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamyar Kamrani

Tehran University of Medical Sciences

kamyarkamrani48@gmail.com+98 21 7301 3000

Outcome results

None listed

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