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

Phase 3

• Conditions: Bronchopulmonary dysplasia.; Bronchopulmonary dysplasia originating in the perinatal period; P27.1

• Registration Number: IRCT20221016056205N1
• Lead Sponsor: Karaj University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.