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Comparison of the effect of surfactant with and without salbutamol in the treatment of premature newborns with respiratory distress syndrome

Investigating the efficiacy of surfactant with ventolin or without ventolin in the treatment of prematur newborns with respiratory distress syndrome.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151220025619N5
Enrollment
84
Registered
2019-03-06
Start date
2019-01-30
Completion date
Unknown
Last updated
2019-03-25

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: In the intervention group, neonates will receive an inhaled venolyme dose of 0.2 mg / kg by nebulizer for 20 minutes in addition to the surfactant. Intervention 2:

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Gestational age 28 to 34 weeks Having respiratory distress syndrome Weight above 1 kg Negative blood culture The need for oxygen and respiratory protection Need to inject surfactant

Exclusion criteria

Exclusion criteria: Absence of radiographic findings in favor of respiratory distress syndrome Asphyxia at birth Birth trauma Congenital anomalies Severe metabolic acidosis Heart rate is more than 180 in minutes

Design outcomes

Primary

MeasureTime frame
Time to start oral feeding. Timepoint: Every day until you get independent oral nutrition. Method of measurement: View and register.;Duration of receiving oxygen. Timepoint: every hour. Method of measurement: Pulse oximetry.;Reply to treatment. Timepoint: every hour. Method of measurement: monitor.;Duration of treatment with cpap. Timepoint: every hour. Method of measurement: Pulse oximetry.

Secondary

MeasureTime frame
Length of hospitalization. Timepoint: It is determined by the number of hospital days. Method of measurement: Count the days of hospitalization.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Homa Babaei

Kermanshah University of Medical Sciences

Homa_babaei@kums.ac.ir+98 83 3427 6302

Outcome results

None listed

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