Curosurf/Budesonide for Infants With Respiratory Distress Syndrome (Budesonide)

December 6, 2017 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria:

  • pneumothorax
  • surgical disease
  • major congenical defects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need of pulmonary surfactant
Time Frame: one month
The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of bronchopulmonary dysplasia
Time Frame: gestional age 36 weeks or later
the hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.
gestional age 36 weeks or later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
need of intubation
Time Frame: one month
The hypothesis is Cursurf/Budesonide could reduced the need of intubation
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • curosurf/Budesonide for NRDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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