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Heliox in Preterm Infants With Respiratory Distress Syndrome

NCT ID: NCT01759316

Last Updated: 2013-10-28

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-08-31

Brief Summary

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Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Detailed Description

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Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Heliox has not been widely used. More studies on the effects and safety of Heliox in addition to NIPPV and mechanical ventilation should be tried.

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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heliox

Heliox is use in this group

Group Type ACTIVE_COMPARATOR

heliox

Intervention Type OTHER

heliox or oxygen is used in the two groups respectively

Placebo

Oxygen is used in this group

Group Type PLACEBO_COMPARATOR

heliox

Intervention Type OTHER

heliox or oxygen is used in the two groups respectively

Interventions

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heliox

heliox or oxygen is used in the two groups respectively

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational age more than 28 weeks and less than 32 weeks
* Diagnosed as respiratory distress syndrome
* Need to use NIPPV ventilation
* No congenital diseases or hereditary diseases
* With an informed consent form

Exclusion Criteria

* With congenital diseases or hereditary diseases
* Intubated in the delivery room
* Need surgery
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yuan Shi

Director, Head of Pediatrics, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuan Shi, MD, PhD

Role: STUDY_CHAIR

Dpartment of Pediatrics, Daping Hospital, Third Military Medical University

Locations

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Daping Hospital

China, Chongqing Municipality, China

Site Status

Daping Hospital and Research Institute of Surgery

Chongqing, , China

Site Status

Countries

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China

Other Identifiers

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Lixue

Identifier Type: -

Identifier Source: org_study_id