Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Respiratory Distress Syndrome Clinical Trial

— Budesonide  

Official title:

Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013115
• Other study ID #: curosurf/Budesonide for NRDS
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: December 6, 2017
• Start date: January 1, 2015
• Est. completion date: October 30, 2017

Study information

• Verified date: December 2013
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Hours

Eligibility

Inclusion Criteria:

• Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria:

• pneumothorax

• surgical disease

• major congenical defects

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Budesonide
Experimental: Cursurf and Budesonide The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	need of intubation	The hypothesis is Cursurf/Budesonide could reduced the need of intubation	one month
Primary	need of pulmonary surfactant	The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant	one month
Secondary	the incidence of bronchopulmonary dysplasia	the hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.	gestional age 36 weeks or later