Meconium Aspiration SyndromeNCT01274845
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
A study testing Heliox mechanical ventilation in people with Meconium Aspiration Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- Heliox mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2006to Dec 2008
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- meconium aspiration syndrome diagnosed based on clinical and radiological findings,
- respiratory failure requiring mechanical ventilation
Who cannot join
- congenital malformations or congenital genetic syndromes,
- persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Neonatology at Poznań University of Medical Sciences
Poznan, 60-535
About this study
The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- Heliox mechanical ventilation
- Keywords
- Meconium aspiration syndrome, Heliox, Mechanical ventilation, Newborn
- 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.
Heliox mechanical ventilationOther
Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.
| Study group | Role | What they receive |
|---|---|---|
| Heliox | Other | Not described Receives: Other: Heliox mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in acid-base balance and oxygenation
Acid-base balance and oxygenation assessed on arterial blood gas samples, saturation measured with a pulse oximeter and calculated values of oxygenation index and alveolar-arterial oxygen tension difference.
Measured: Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
Secondary outcomes (1)
Changes in respiratory parameters
Analyzed parameters: tidal volume (VT, [ml/kg]), minute ventilation (VE, [l]) and peak expiratory flow rate (PEFR, [l/min]). Recorded ventilator settings: respiratory rate (RR), mean airway pressure (MAP) and fraction of inspired oxygen (FiO2).
Measured: Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Aspiration 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Tomasz Szczapa, MD, PhD, Principal investigator, Department of Neonatology at Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274845
- Sponsor's protocol ID
- 503-02-02215338-22961-03550
- Status last verified
- Jan 2011
- First submitted
- 10 Jan 2011
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
- ClinicalTrials.gov ID
- NCT01274845
- Acronym / sponsor ID
- 503-02-02215338-22961-03550
- Conditions
- Meconium Aspiration Syndrome
- Keywords
- Meconium aspiration syndrome, Heliox, Mechanical ventilation, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Jan 2011 (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.
The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heliox | Other | Other: Heliox mechanical ventilation |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- meconium aspiration syndrome diagnosed based on clinical and radiological findings,
- respiratory failure requiring mechanical ventilation
Key exclusion criteria (2 listed)
- congenital malformations or congenital genetic syndromes,
- persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide 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 mechanical ventilationMechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen. | Other | Heliox |
Primary outcome
Changes in acid-base balance and oxygenation
Time frame: Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
Acid-base balance and oxygenation assessed on arterial blood gas samples, saturation measured with a pulse oximeter and calculated values of oxygenation index and alveolar-arterial oxygen tension difference.
1 secondary outcome
Changes in respiratory parameters
Time frame: Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
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 12 Jan 2011.
Related trials for Meconium Aspiration Syndrome
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
RecruitingObservational study
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruiting
Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
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.
Tomasz Szczapa, MD, PhD principal investigator
Department of Neonatology at Poznań University of Medical Sciences
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 mechanical ventilation in people with Meconium Aspiration Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
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 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: finished, as of the sponsor's last update on 12 Jan 2011. 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 Poland. 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?
Changes in acid-base balance and oxygenation (time frame: Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.). 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 12 Jan 2011.