Respiratory Distress SyndromeNCT01759316
Heliox in Preterm Infants With Respiratory Distress Syndrome
A study testing heliox in people with Respiratory Distress Syndrome, run by Third Military Medical University at 2 sites in China.
Trial summary
Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation. Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- heliox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- With congenital diseases or hereditary diseases
- Intubated in the delivery room
- Need surgery
Trial locations and contacts
2 sites in 1 country.
China2 sites
Daping Hospital
China, Chongqing Municipality, 400042
Daping Hospital and Research Institute of Surgery
Chongqing
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- heliox
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helioxOther
heliox or oxygen is used in the two groups respectively
| Study group | Role | What they receive |
|---|---|---|
| heliox | Active comparator | Heliox is use in this group Receives: Other: heliox |
| Placebo | Placebo comparator | Oxygen is used in this group Receives: Other: heliox |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of ventilation and risk of mechanical ventilation
The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (1)
Transcutaneous blood gas analysis，ventilator parameters and lung inflammation cytokines
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Shi, Third Military Medical University
- Investigators
- Yuan Shi, MD, PhD, Study chair, Dpartment of Pediatrics, Daping Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759316
- Sponsor's protocol ID
- Lixue
- Status last verified
- Oct 2013
- First submitted
- 7 Dec 2012
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01759316
- Acronym / sponsor ID
- Lixue
- Conditions
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heliox | Active comparator | Other: helioxHeliox is use in this group |
| Placebo | Placebo comparator | Other: helioxOxygen is used in this group |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- With congenital diseases or hereditary diseases
- Intubated in the delivery room
- Need surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| helioxheliox or oxygen is used in the two groups respectively | Other | Placebo, heliox |
Primary outcome
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
The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Shi, MD, PhD study chair
Dpartment of Pediatrics, Daping Hospital, Third Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heliox in people with Respiratory Distress Syndrome, run by Third Military Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.