ARDSNCT03217149
Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)
A study testing heliox combined with MV and MV in people with ARDS, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality. Read more about this study
- Who is it for?
- Ages 30 minutes to 28 days
- Conditions the study is for
- ARDS
- What is being tested?
- heliox combined with MV and MV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Aug 2020
- 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 30 minutes to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infant less than 28 days
- diagnosis of ARDS
- informed parental consent has been obtained
Who cannot join
- major congenital malformations or complex congenital heart disease
- transferred out of the neonatal intensive care unit without treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Juan Ma, physician, 18680887330, zoe330@163.com
About this study
Official title: Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.
Read the detailed description
Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.
- Conditions
- ARDS
- Being tested
- heliox combined with MV, MV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heliox combined with MVDrug
heliox combined with MV is given to infant with ARDS
MVDrug
MV is given to infant with ARDS
| Study group | Role | What they receive |
|---|---|---|
| heliox combined with mechanical ventilation (MV) | Experimental | heliox combined with mechanical ventilation (MV) is given to infant with ARDS Receives: Drug: heliox combined with MV |
| mechanical ventilation | Active comparator | mechanical ventilation (MV) is given to infant with ARDS Receives: Drug: MV |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death
Measured: within 100 days
Secondary outcomes (1)
Bayley Scales of Infant Development
the survival is assessed by Bayley Scales of Infant Development
Measured: at 2 months old and 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Sep 2017 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, PhD,MD, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217149
- Sponsor's protocol ID
- heliox for ARDS
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03217149
- Acronym / sponsor ID
- heliox for ARDS
- Conditions
- ARDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 13 Jul 2017 (actual)
- 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.
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.
Detailed description
Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heliox combined with mechanical ventilation (MV) | Experimental | Drug: heliox combined with MVheliox combined with mechanical ventilation (MV) is given to infant with ARDS |
| mechanical ventilation | Active comparator | Drug: MVmechanical ventilation (MV) is given to infant with ARDS |
Who may qualify
- Ages
- 30 minutes to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infant less than 28 days
- diagnosis of ARDS
- informed parental consent has been obtained
Key exclusion criteria (2 listed)
- major congenital malformations or complex congenital heart disease
- transferred out of the neonatal intensive care unit without treatment
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 |
|---|---|---|
| heliox combined with MVheliox combined with MV is given to infant with ARDS | Drug | heliox combined with mechanical ventilation (MV) |
| MVMV is given to infant with ARDS | Drug | mechanical ventilation |
Primary outcome
death
Time frame: within 100 days
death
1 secondary outcome
Bayley Scales of Infant Development
Time frame: at 2 months old and 2 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for ARDS
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Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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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.
Shi Yuan, PhD,MD study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heliox combined with MV and MV in people with ARDS, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Juan, MD (13883559467, 476679422@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: within 100 days). 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 13 Jul 2017.