Heliox in Preterm Infants With Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuan Shi, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01759316
First received: December 7, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Respiratory Distress Syndrome
Other: heliox

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • length of ventilation and risk of mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.


Secondary Outcome Measures:
  • Transcutaneous blood gas analysis,ventilator parameters and lung inflammation cytokines [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   28 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759316

Locations
China, Chongqing
Daping Hospital
China, Chongqing, China, 400042
China
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
  More Information

No publications provided

Responsible Party: Yuan Shi, Director, Head of Pediatrics, Principal Investigator, Clinical Professor, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01759316     History of Changes
Other Study ID Numbers: Lixue
Study First Received: December 7, 2012
Last Updated: October 25, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 26, 2014