Heliox in Preterm Infants With Respiratory Distress Syndrome

• Sponsor: Third Military Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01759316
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 18
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	Other: heliox	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. length of ventilation and risk of mechanical ventilation [participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

   The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Weeks to 37 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daping Hospital	China	Chongqing	China	400042
2	Daping Hospital and Research Institute of Surgery	Chongqing		China

Sponsors and Collaborators

• Third Military Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuan Shi, Director, Head of Pediatrics, Principal Investigator, Clinical Professor, Third Military Medical University
• ClinicalTrials.gov Identifier: NCT01759316
• Other Study ID Numbers: Lixue
• First Posted: Jan 3, 2013
• Last Update Posted: Oct 28, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome

Study Results

No Results Posted as of Oct 28, 2013