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Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

NCT ID: NCT02013115

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome

Keywords

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infant respiratory distress syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cursurf

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Cursurf and Budesonide

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

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

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

Interventions

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Budesonide

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

Intervention Type DRUG

Other Intervention Names

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Pumicort

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria

* pneumothorax
* surgical disease
* major congenical defects
Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Chen Long,MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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curosurf/Budesonide for NRDS

Identifier Type: -

Identifier Source: org_study_id