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

Phase 3

Recruiting

Conditions: Respiratory distress syndrome.
Respiratory distress syndrome of newborn
P22.0

Registration Number: IRCT20200805048312N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 62

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ength 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.