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

Phase 3

Recruiting

• Conditions: Condition 1: Bronchopulmonary dysplasia. Condition 2: Respiratory Distress syndrome.; Bronchopulmonary dysplasia originating in the perinatal period; Respiratory distress syndrome of newborn; P27.1; P22.0

• Registration Number: IRCT20211107052993N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 296

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.