Skip to content

Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD)

Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD) compared with surfactant alone in the treatment of respiratory distress syndrome in preterm infants.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211107052993N1
Enrollment
296
Registered
2021-11-21
Start date
2021-11-10
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Condition 1: Bronchopulmonary dysplasia. Condition 2: Respiratory Distress syndrome. Bronchopulmonary dysplasia originating in the perinatal period Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: Simultaneous intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight) and budesonide (budesonide at a dose of 0.25 mg / kg b

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 30 Days

Inclusion criteria

Inclusion criteria: Premature infants with a Gestational age less than 37 weeks weighing less than 1,500 g Premature infants admitted to the Neonatal ward due to Respiratory distress syndrome based on clinical and radiological symptoms and negative blood culture at birth; And receives any non-invasive respiratory support, and requires a surfactant injection at the physician's discretion.

Exclusion criteria

Exclusion criteria: Congenital major anomalies that affect the baby's breathing Existence of asphyxia; (Apgar score less than 7 in 5 minutes of birth) Parental dissatisfaction Gastrointestinal abnormalities that cause the baby to be transferred to another center Congenital cyanotic heart disease

Design outcomes

Primary

MeasureTime frame
Bronchopulmonary dysplasia. Timepoint: daily , end of 6 week or discharge time. Method of measurement: clinical.;Duration of auxiliary oxygen reception. Timepoint: daily , end of 6 week or discharge time. Method of measurement: clinical.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezoo Aminyan daryasari

Iran University of Medical Sciences

a.aminyan@yahoo.com+98 13 4222 9638

Outcome results

None listed

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