Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Drug: Budesonide

• Registration Number: NCT02013115
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome usually need the second or more pulmonary surfactant and is easier to developing to Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome, Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of Brochopulmonary dysplasia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Study Start: 2015-01-01
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria

• pneumothorax
• surgical disease
• major congenical defects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cursurf and Budesonide	Budesonide	The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation.

Primary Outcome Measures

Name	Time	Method
need of pulmonary surfactant	one month	The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant

Secondary Outcome Measures

Name	Time	Method
the incidence of bronchopulmonary dysplasia	gestional age 36 weeks or later	the hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.

Trial Locations

Locations (1)

Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China