Skip to content

Comparison of the effect of intra tracheal injection of budesonide with surfactant and surfactant alone in prevention of Bronchopulmonary Dysplasia in preterm infant under ?? week with Respiratory Distress Syndrome A Randomized Cilinical Trial

Comparison of the effect of intra tracheal injection of budesonide with surfactant and surfactant alone in prevention of Bronchopulmonary Dysplasia in preterm infant under ?? week with Respiratory Distress Syndrome A Randomized Cilinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221016056205N1
Enrollment
150
Registered
2023-05-15
Start date
2022-11-22
Completion date
Unknown
Last updated
2023-05-29

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: Preterm infants who meet the conditions for entering the study are included in the study as available samples and are placed in one of the following two groups based on listrandomizati

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 7 Months

Inclusion criteria

Inclusion criteria: All preterm babies with birth age less than 30 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: A baby born less than 24 weeks old A baby with a birth weight of less than 400 grams A baby with a fatal congenital abnormality or disorder Presence of cardiopulmonary diseases

Design outcomes

Primary

MeasureTime frame
Severity of BPD: BPD will be divided into three groups in terms of severity: mild, which means that they do not need oxygen at the age of 36 weeks of pregnancy, and moderate, which means that they need less than 30% of oxygen in the 36th week of pregnancy. Severe need for 30% oxygen with or without positive pressure ventilation or continuous positive pressure at 36 weeks of gestation. Timepoint: After 28 days. Method of measurement: Physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Kianpishe

Karaj University of Medical Sciences

atkntu94@gmail.com+98 21 4426 3952

Outcome results

None listed

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