Heliox in Preterm Infants With Respiratory Distress Syndrome

Respiratory Distress Syndrome Clinical Trial

Official title:

Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759316
• Other study ID #: Lixue
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: October 25, 2013
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 37 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• heliox
heliox or oxygen is used in the two groups respectively

Locations

Country	Name	City	State
China	Daping Hospital	China	Chongqing
China	Daping Hospital and Research Institute of Surgery	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of ventilation and risk of mechanical ventilation	The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Yes
Secondary	Transcutaneous blood gas analysis,ventilator parameters and lung inflammation cytokines		participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Yes