Effect of oral bosentan in preventing Bronchopulmonary Dysplasia (BPD) in premature infants with respiratory distress syndrome

Comparison effect of oral bosentan in preventing Bronchopulmonary Dysplasia (BPD) in premature infants with respiratory distress syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260119068615N1

Enrollment

Registered

2026-02-14

Start date

2026-04-04

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Bronchopulmonary Dysplasia. Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention 1: Intervention group: Oral bosentan plus surfactant (BLES). Intervention 2: Control group: routin treatment surfactant (BLES).

Eligibility

Sex/Gender

All

Age

No minimum to 5 Days

Inclusion criteria

Inclusion criteria: Babies with a gestational age of less than or equal to 37 weeks With moderate or severe neonatal respiratory distress syndrome requiring mechanical ventilation Requires an inspiratory oxygen fraction greater than 30% Absence of severe congenital anomalies

Exclusion criteria

Exclusion criteria: Severe asphyxia Cardiovascular instability shock Oral intolerance to medications The presence of drug side effects

Design outcomes

Primary

Measure	Time frame
Severity of respiratory distress at birth. Timepoint: Measurement periods include 1, 2, 3, 5, 7, and 10 days. Method of measurement: Based on neonatal respiratory score.	—

Secondary

Measure	Time frame
The need for oxygen or ventilation. Timepoint: Measurement periods include 14 and 28 days after the intervention. Method of measurement: Based on the review of diagnostic criteria in favor of bronchopulmonary.;Length of hospital stay. Timepoint: One month. Method of measurement: Counting the number of days hospitalized.;Duration of mechanical ventilation. Timepoint: After discharge. Method of measurement: Counting the days you need mechanical ventilation.;Pneumothorax. Timepoint: After discharge. Method of measurement: Chest X-ray.;Pulmonary hemorrhage. Timepoint: The time points are 14 and 28 days after the intervention. Method of measurement: Chest X-ray.;Intraventricular hemorrhage. Timepoint: The time points are 14 and 28 days after the intervention. Method of measurement: Brain ultrasound.;Average airway pressure. Timepoint: On the first and third day of treatment. Method of measurement: Ventilator.;Need for next dose of surfactant. Timepoint: The first three days of hospitalization. Method of measurement: Patient file.	—

Measure

Time frame

The need for oxygen or ventilation. Timepoint: Measurement periods include 14 and 28 days after the intervention. Method of measurement: Based on the review of diagnostic criteria in favor of bronchopulmonary.;Length of hospital stay. Timepoint: One month. Method of measurement: Counting the number of days hospitalized.;Duration of mechanical ventilation. Timepoint: After discharge. Method of measurement: Counting the days you need mechanical ventilation.;Pneumothorax. Timepoint: After discharge. Method of measurement: Chest X-ray.;Pulmonary hemorrhage. Timepoint: The time points are 14 and 28 days after the intervention. Method of measurement: Chest X-ray.;Intraventricular hemorrhage. Timepoint: The time points are 14 and 28 days after the intervention. Method of measurement: Brain ultrasound.;Average airway pressure. Timepoint: On the first and third day of treatment. Method of measurement: Ventilator.;Need for next dose of surfactant. Timepoint: The first three days of hospitalization. Method of measurement: Patient file.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Akhundzadeh

Arak University of Medical Sciences

a.akhondzadeh@arakmu.ac.ir+98 86 3313 4717

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026