Prolonged Mechanical VentilationNCT04511741
Epidemiological Survey of Children With Prolonged Mechanical Ventilation.
An observational study of Prolonged Mechanical Ventilation, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Prolonged Mechanical Ventilation
- How many people
- 346 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2020to 1 Jul 2023
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients who need prolonged mechanical ventilation aged from one month to 18 years old.
Inclusion Criteria: patients who need prolonged mechanical ventilation aged from one month to 18 years old.
-
Exclusion Criteria: Other clinical conditions not suitable to participate considered by investigator.
-
Trial locations and contacts
1 site in 1 country.
China1 site
Children' hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation.
Read the detailed description
Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation. There is a lack of data on children with long-term mechanical ventilation in China.The investigators conducted this study to investigate the clinical characteristics of children with long-term mechanical ventilation in China. The investigators conducted a multicenter clinical epidemiological survey.The study included PICU wards in major children's hospitals in China and investigated the causes of prolonged mechanical ventilation, the outcome of long-term mechanical ventilation.PMV definition: continuous invasive or noninvasive ventilation time ≥ 21 days, daily ≥ 6 hours.
- Conditions
- Prolonged Mechanical Ventilation
- Being tested
- no intervention, it is an observational study.
- Keywords
- prolonged mechanical ventilation, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, it is an observational study.Other
no intervention, it is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| invasive mechanical ventilation | Not described Receives: Other: no intervention, it is an observational study. | |
| non invasive mechanical ventilation | Not described Receives: Other: no intervention, it is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cause of prolonged mechanical ventilation
This is a categorical variable. The reasons for the prolonged mechanical ventilation wolud be recorded, includes neuromuscular diseases, upper respiratory airway diseases, central nervous system diseases, lower respiratory airway diseases, abnormal ventilation control diseases.
Measured: At enrollment
Secondary outcomes (2)
mortality rate
The mortality rate among patients received prolonged mechanical ventilation.
Measured: During the procedure (about 2 years)
the length of prolonged mechanical ventilaton
The length of prolonged mechanical ventilaton among patients would be recorded during the hospitalization and after discharging.
Measured: During the procedure (about 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start15 Nov 2020
- Primary completion15 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Weiming, Study director, children' hospital of Fudan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511741
- Sponsor's protocol ID
- CHFudanUCWM
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2020
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Racca F, Berta G, Sequi M, Bignamini E, Capello E, Cutrera R, Ottonello G, Ranieri VM, Salvo I, Testa R, Wolfler A, Bonati M; LTV Pediatric Italian Network. Long-term home ventilation of children in Italy: a national survey. Pediatr Pulmonol. 2011 Jun;46(6):566-72. doi: 10.1002/ppul.21401. Epub 2010 Dec 30.
PubMed 21560263
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Survey of Children With Prolonged Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT04511741
- Acronym / sponsor ID
- CHFudanUCWM
- Conditions
- Prolonged Mechanical Ventilation
- Keywords
- prolonged mechanical ventilation, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 13 Aug 2020 (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.
Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation.
Detailed description
Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation. There is a lack of data on children with long-term mechanical ventilation in China.The investigators conducted this study to investigate the clinical characteristics of children with long-term mechanical ventilation in China. The investigators conducted a multicenter clinical epidemiological survey.The study included PICU wards in major children's hospitals in China and investigated the causes of prolonged mechanical ventilation, the outcome of long-term mechanical ventilation.PMV definition: continuous invasive or noninvasive ventilation time ≥ 21 days, daily ≥ 6 hours.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| invasive mechanical ventilation | – | Other: no intervention, it is an observational study. |
| non invasive mechanical ventilation | – | Other: no intervention, it is an observational study. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients who need prolonged mechanical ventilation aged from one month to 18 years old.
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 |
|---|---|---|
| no intervention, it is an observational study.no intervention, it is an observational study. | Other | invasive mechanical ventilation, non invasive mechanical ventilation |
Primary outcome
the cause of prolonged mechanical ventilation
Time frame: At enrollment
This is a categorical variable. The reasons for the prolonged mechanical ventilation wolud be recorded, includes neuromuscular diseases, upper respiratory airway diseases, central nervous system diseases, lower respiratory airway diseases, abnormal ventilation control diseases.
2 secondary outcomes
mortality rate
Time frame: During the procedure (about 2 years)
the length of prolonged mechanical ventilaton
Time frame: During the procedure (about 2 years)
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 19 Mar 2026.
- Background: PubMed 21560263Racca F, Berta G, Sequi M, Bignamini E, Capello E, Cutrera R, Ottonello G, Ranieri VM, Salvo I, Testa R, Wolfler A, Bonati M; LTV Pediatric Italian Network. Long-term home ventilation of children in Italy: a national survey. Pediatr Pulmonol. 2011 Jun;46(6):566-72. doi: 10.1002/ppul.21401. Epub 2010 Dec 30.
- Individual participant dataSharing planned: Undecided
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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.
Chen Weiming study director
children' hospital of Fudan university
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 Prolonged Mechanical Ventilation, run by Children's Hospital of Fudan 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?
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 19 Mar 2026. 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?
the cause of prolonged mechanical ventilation (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511741, which also lists 1 linked publication.
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 19 Mar 2026.