Skip to content

The effect of budesonide and surfactant in the treatment of respiratory distress syndrome

Comparison of the combined effect of budesonide and surfactant with surfactant alone in the treatment of respiratory distress syndrome and prevention of bronchopulmonary dysplasia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241116063727N1
Enrollment
160
Registered
2024-11-30
Start date
2024-11-30
Completion date
Unknown
Last updated
2025-01-08

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

Premature infants who meet the eligibility criteria for the study are included in the study through convenience sampling and are randomly assigned to treatment with budesonide and surfactant or surfac

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 90 Days

Inclusion criteria

Inclusion criteria: All preterm babies with birth age less than 32 weeks provided they have respiratory distress syndrome (RDS) There is evidence of RDS in chest X-ray and ABG and they are candidates to receive surfactant Babies born at the hip less than 24 weeks of pregnancy - with a birth weight of less than 400 grams - the presence of congenital cardiopulmonary disease - conditions for not entering the study

Exclusion criteria

Exclusion criteria: Major Congenital Anomaly: Congenital heart disease excluding atrial septal defect and patent ductus arteriosus, in newborns experiencing asphyxia (Apgar score less than 4 at 5 minutes post-birth), evidence of necrotizing enterocolitis prior to surfactant administration, presence of major congenital anomalies, chromosomal disorders, heart failure requiring treatment, shock, esophageal atresia, and diaphragmatic hernia

Design outcomes

Primary

MeasureTime frame
BPD (Bronchopulmonary Dysplasia) is classified into three severity categories based on the need for oxygen support at 36 weeks of gestational age: Mild BPD indicates that infants do not require any supplemental oxygen; Moderate BPD means infants need less than 30% oxygen; and Severe BPD refers to infants requiring 30% oxygen or more, with or without positive pressure ventilation at 36 weeks of gestation. Timepoint: Daily for the first three days of life, and for three days after the intervention, and 30-42 days later.". Method of measurement: Clinical Examination.

Secondary

MeasureTime frame
Bronchopulmonary Dysplasia (BPD) is classified into three severity levels: Mild BPD refers to infants who do not require oxygen at 36 weeks of gestational age. Moderate BPD is characterized by infants needing less than 30% oxygen at the same gestational age. Severe BPD involves infants requiring 30% oxygen or more, which may include the use of positive pressure ventilation or continuous positive airway pressure (CPAP) at 36 weeks of gestational age. This classification helps in determining the management and care required for affected infants. Timepoint: 28 days later. Method of measurement: Clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHanieh Talebi

Hamedan University of Medical Sciences

Talebi_hanieh@yahoo.com+98 81 3823 8850

Outcome results

None listed

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