- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02013115
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
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
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Chongqing
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Chongqing, Chongqing, China, 400042
- Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
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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.
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Experimental: Cursurf and Budesonide
The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation.
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Experimental: Cursurf and Budesonide The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation
Other Names:
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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
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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.
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gestional age 36 weeks or later
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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
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one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
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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Faron Pharmaceuticals LtdSeventh Framework ProgrammeTerminatedRespiratory Distress Syndrome, AdultSpain, United Kingdom, France, Italy, Finland, Czechia, Belgium, Germany
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Postgraduate Institute of Medical Education and...TerminatedAcute Respiratory Distress Syndrome (ARDS)India
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West Penn Allegheny Health SystemCompleted
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University of MiamiAstraZenecaCompleted
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Meir Medical CenterUnknown
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St. Paul's Hospital, CanadaUnknown
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Research in Real-Life LtdOrion Corporation, Orion PharmaCompleted
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Aquilon Pharmaceuticals S.A.Completed
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AstraZenecaCompleted
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Dr. Falk Pharma GmbHCompletedEosinophilic EsophagitisGermany
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Reig Jofre GroupCompletedAllergySouth Africa