Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02013115
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.9
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	Drug: Budesonide	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Curosurf/Budesonide for Infants With Respiratory Distress Syndrome
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Oct 30, 2017
• Actual Study Completion Date: Oct 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Cursurf The baby with respiratory distress syndrome was given Cursurf through intubation.
Experimental: Cursurf and Budesonide The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation.	Drug: Budesonide; Experimental: Cursurf and Budesonide The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation; Other Names: Pumicort

Outcome Measures

Primary Outcome Measures

1. need of pulmonary surfactant [one month]

   The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant

Secondary Outcome Measures

1. the incidence of bronchopulmonary dysplasia [gestional age 36 weeks or later]

   the hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.

Other Outcome Measures

1. need of intubation [one month]

   The hypothesis is Cursurf/Budesonide could reduced the need of intubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria:

• pneumothorax

• surgical disease

• major congenical defects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chen Long,MD, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• ClinicalTrials.gov Identifier: NCT02013115
• Other Study ID Numbers: curosurf/Budesonide for NRDS
• First Posted: Dec 17, 2013
• Last Update Posted: Dec 7, 2017
• Last Verified: Dec 1, 2013

• Keywords provided by Chen Long,MD, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: infant; respiratory distress syndrome
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome; Budesonide

Study Results

No Results Posted as of Dec 7, 2017