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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring infant, respiratory distress syndrome

Eligibility Criteria

undefined - 12 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria:

  • pneumothorax
  • surgical disease
  • major congenical defects

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Cursurf

Cursurf and Budesonide

Arm Description

The baby with respiratory distress syndrome was given Cursurf through intubation.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2013
Last Updated
December 6, 2017
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02013115
Brief Title
Curosurf/Budesonide for Infants With Respiratory Distress Syndrome
Acronym
Budesonide
Official Title
Curosurf/Budesonide for Infants With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
infant, respiratory distress syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cursurf
Arm Type
No Intervention
Arm Description
The baby with respiratory distress syndrome was given Cursurf through intubation.
Arm Title
Cursurf and Budesonide
Arm Type
Experimental
Arm Description
The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation.
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Pumicort
Intervention Description
Experimental: Cursurf and Budesonide The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation
Primary Outcome Measure Information:
Title
need of pulmonary surfactant
Description
The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant
Time Frame
one month
Secondary Outcome Measure Information:
Title
the incidence of bronchopulmonary dysplasia
Description
the hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.
Time Frame
gestional age 36 weeks or later
Other Pre-specified Outcome Measures:
Title
need of intubation
Description
The hypothesis is Cursurf/Budesonide could reduced the need of intubation
Time Frame
one month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of respiratory distress syndrome Exclusion Criteria: pneumothorax surgical disease major congenical defects
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

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Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

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