Non Invasive VentilationNPO-NIVNCT03385421
Nutritional Practices and Outcomes in Non-Invasive Ventilation
An observational study of Non Invasive Ventilation, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. Read more about this study
- Who is it for?
- Ages 3 days to 18 years
- Conditions the study is for
- Non Invasive Ventilation
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 10 Oct 2018
- Phase
- Observational
- 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 3 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Population admitted to PICU in whom NIV was initiated
Who may be able to join
- Patient admitted to the Pediatric ICU
- in whom noninvasive ventilation (NIV) was initiated within previous 48 hours (NIV use includes any High Flow Nasal Canula > 2 lpm flow , continuous positive airway pressure or bilevel pressure or neurally adjusted ventilatory assist)
Who cannot join
- Patients with:
- chronic home NIV use for >12 hours per day
- limitations of care decisions made
- Cardiac surgery during this admission
- Acute gastro intestinal bleeds
- Abdominal surgery in previous 48 hours
Show all 9Show fewer
- Gut graft versus host disease
- Chronic parenteral nutrition
- Short Gut Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. The goal of NPO/NIV is to understand how non-invasive ventilation (NIV) is used to treat critically ill children and, concurrently, how these children are fed while on NIV. Designed as a period prevalence study, NPO/NIV will collect observational, cross-sectional data over the course of five study weeks. Each study week will require two days of screening for eligible patients. On Mondays, study staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days after the initiation of NIV or until the patient is discharged from the pediatric intensive care unit. This study was granted exempt status by the University of Arizona Human Subjects Protection Program, including a waiver of informed consent. As no personal health information is transmitted during the course of the study, the University of Arizona does not require Data Use Agreements between sites to participate.
- Conditions
- Non Invasive Ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start1 Mar 2017
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Invasive VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EssaiClinique_NPO-NIV, University Hospital, Grenoble
- Investigators
- Katri Typpo, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385421
- Sponsor's protocol ID
- 38RC17.173
- Acronym
- NPO-NIV
- Status last verified
- Mar 2020
- First submitted
- 20 Dec 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Practices and Outcomes in Non-Invasive Ventilation
- ClinicalTrials.gov ID
- NCT03385421
- Acronym / sponsor ID
- NPO-NIV / 38RC17.173
- Conditions
- Non Invasive Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 28 Dec 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.
The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. The goal of NPO/NIV is to understand how non-invasive ventilation (NIV) is used to treat critically ill children and, concurrently, how these children are fed while on NIV. Designed as a period prevalence study, NPO/NIV will collect observational, cross-sectional data over the course of five study weeks. Each study week will require two days of screening for eligible patients. On Mondays, study staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days after the initiation of NIV or until the patient is discharged from the pediatric intensive care unit. This study was granted exempt status by the University of Arizona Human Subjects Protection Program, including a waiver of informed consent. As no personal health information is transmitted during the course of the study, the University of Arizona does not require Data Use Agreements between sites to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Population admitted to PICU in whom NIV was initiated
Key inclusion criteria (2 listed)
- Patient admitted to the Pediatric ICU
- in whom noninvasive ventilation (NIV) was initiated within previous 48 hours (NIV use includes any High Flow Nasal Canula > 2 lpm flow , continuous positive airway pressure or bilevel pressure or neurally adjusted ventilatory assist)
Key exclusion criteria (9 listed)
- chronic home NIV use for >12 hours per day
- limitations of care decisions made
- Cardiac surgery during this admission
- Acute gastro intestinal bleeds
- Abdominal surgery in previous 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospital mortality
Time frame: 90 days
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 24 Mar 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.
Katri Typpo principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Invasive Ventilation, run by University Hospital, Grenoble at 1 site in France.
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 9 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 24 Mar 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 France. 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?
hospital mortality (time frame: 90 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 24 Mar 2020.