Heliox in Preterm Infants With Respiratory Distress Syndrome

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Other: heliox

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Daping Hospital and Research Institute of Surgery
  • Chongqing
    • China, Chongqing, China, 400042
      • Daping Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: heliox; Heliox is use in this group	Other: heliox; heliox or oxygen is used in the two groups respectively
Placebo Comparator: Placebo; Oxygen is used in this group	Other: heliox; heliox or oxygen is used in the two groups respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Chair: Yuan Shi, MD, PhD, Dpartment of Pediatrics, Daping Hospital, Third Military Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 30, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• 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
• Other Study ID Numbers: Lixue