Neonatal Meconium AspirationNCT02620891
Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome
A study testing helium oxygen mixture in people with Neonatal Meconium Aspiration, run by Ma Juan at 1 site in China.
Trial summary
Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of… Read more about this study
- Who is it for?
- Ages 37 to 40 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Meconium Aspiration
- What is being tested?
- helium oxygen mixture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2015to 1 Apr 2017
- 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 37 to 40 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject has the diagnosis of neonatal meconium aspiration syndrome
- Subject has Synchronous instruction ventilation
Who cannot join
- History of congenital or hereditary disease
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation
Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.
- Conditions
- Neonatal Meconium Aspiration
- Being tested
- helium oxygen mixture
- Keywords
- helium oxygen mixture, Meconium aspiration syndrome
- Medical subject headings
- Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helium oxygen mixtureDevice
Also called Air oxygen mixture
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Active comparator | Using helium oxygen mixture Receives: Device: helium oxygen mixture |
| matched group | No intervention | Using air oxygen mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood gas analysis
Time detection after treatment
Measured: 2 hour
blood gas analysis
Measured: 6 hour
blood gas analysis
Measured: 12 hour
blood gas analysis
Measured: 24 hour
blood gas analysis
Measured: 48 hour
Secondary outcomes (2)
Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
Measured: 0 hour
Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start1 Feb 2015
- Primary completion20 Feb 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Meconium AspirationStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ma Juan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620891
- Sponsor's protocol ID
- MJuan
- Status last verified
- Jan 2020
- First submitted
- 12 Nov 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation
- ClinicalTrials.gov ID
- NCT02620891
- Acronym / sponsor ID
- MJuan
- Conditions
- Neonatal Meconium Aspiration
- Keywords
- helium oxygen mixture, Meconium aspiration syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ma JuanUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 3 Dec 2015 (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.
Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.
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 |
|---|---|---|
| experimental group | Active comparator | Device: helium oxygen mixtureUsing helium oxygen mixture |
| matched group | No intervention | –Using air oxygen mixture |
Who may qualify
- Ages
- 37 to 40 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subject has the diagnosis of neonatal meconium aspiration syndrome
- Subject has Synchronous instruction ventilation
Key exclusion criteria (1 listed)
- History of congenital or hereditary disease
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 |
|---|---|---|
| helium oxygen mixtureAlso: Air oxygen mixture | Device | experimental group |
Primary outcome
blood gas analysis
Time frame: 2 hour
Time detection after treatment
blood gas analysis
Time frame: 6 hour
blood gas analysis
Time frame: 12 hour
blood gas analysis
Time frame: 24 hour
blood gas analysis
Time frame: 48 hour
2 secondary outcomes
Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
Time frame: 0 hour
Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
Time frame: 6 hour
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 7 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing helium oxygen mixture in people with Neonatal Meconium Aspiration, run by Ma Juan 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 2 inclusion and 1 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 7 Jan 2020. 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?
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?
blood gas analysis (time frame: 2 hour). The study lists 5 primary outcomes in all. 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 7 Jan 2020.