Intratracheal Instillation of Pulmonary Surfactant Combined with Budesonide in Preterm Infants with RDS

Phase 2

Completed

• Conditions: Respiratory distress syndrome (RDS) requiring surfactant; respiratory distress syndrome; Bronchopulmonary dysplasia; preterm infant

• Registration Number: TCTR20220310005
• Lead Sponsor: Division of Neonatology Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study Completion: 2023-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Preterm infants born at less than 32 week of gestation or birth weight less than 1800 g who are diagnosed of RDS and require surfactant therapy within 12 after birth

Exclusion Criteria

1. major congenital anomalies
2. parents do not give consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bronchopulmonary dysplasia (BPD) 36 week PMA BPD definition per NICHD 2018 and NIH 2011

Secondary Outcome Measures

Name	Time	Method
ROP 40 wk PMA ROP classification,Duration of oxygen supplementation before discharge Durationof oxygen