Acute Lung InjuryNCT01304654
ALI (Acute Lung Injury) /ARDS (Acute Respiratory Distress Syndrome) in Oncologic Pediatric Patients
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
Trial summary
Identify pediatric oncologic patients with ALI/ARDS at GRAACC (Grupo de Apoio ao Adolescente e a Criança com Câncer) /IOP's (Instituto de Oncologia Pediátrica) Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period. Read more about this study
- Who is it for?
- Ages 29 days to 17 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Neoplasms
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jan 2011to 15 Jun 2013
- 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 29 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric oncologic patients
Who may be able to join
- patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h
Who cannot join
- mechanical ventilation less than 24h
- absence of ALI/ARDS criteria
- no neoplasm diagnosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Grupo de Apoio ao Adolescente e à Criança com Câncer
São Paulo, São Paulo, 04023-062
About this study
Official title: Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed with Acute Lung Injury / Acute Respiratory Distress Syndrome
Identify pediatric oncologic patients with ALI/ARDS at GRAACC (Grupo de Apoio ao Adolescente e a Criança com Câncer) /IOP's (Instituto de Oncologia Pediátrica) Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.
Read the detailed description
Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far.
Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)
- Keywords
- acute lung injury, respiratory distress syndrome, neoplasms, child
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALI/ARDS oncologic patients | Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated
Measured: 2y
Secondary outcomes (1)
Epidemiologic data about the selected patients
Type and data about their mechanical ventilation, etiologic factors for ALI/ARDS, mortality rates, predictive factors about outcomes (death/ discharge), necessity and types of rescue therapies (surfactant, prone position, corticosteroids, etc.)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study start8 Jan 2011
- Primary completion30 Mar 2013
- Study completion15 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Genaro Arduini, Grupo de Apoio ao Adolescente e a Crianca com Cancer
- Investigators
- Rodrigo G Arduini, MD, Principal investigator, Grupo de Apoio ao Adolescente e a Crianca com Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304654
- Sponsor's protocol ID
- UTI/IOP 02/11
- Other IDs
- 0031/11
- Status last verified
- Mar 2013
- First submitted
- 24 Feb 2011
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed with Acute Lung Injury / Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01304654
- Acronym / sponsor ID
- UTI/IOP 02/11
- Keywords
- acute lung injury, respiratory distress syndrome, neoplasms, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com CancerUniversity, hospital or other
- Study start
- 8 Jan 2011
- Primary completion
- 30 Mar 2013 (actual)
- Study completion
- 15 Jun 2013 (actual)
- First posted
- 25 Feb 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.
Identify pediatric oncologic patients with ALI/ARDS at GRAACC (Grupo de Apoio ao Adolescente e a Criança com Câncer) /IOP's (Instituto de Oncologia Pediátrica) Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.
Detailed description
Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far.
Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALI/ARDS oncologic patients | – | –Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months |
Who may qualify
- Ages
- 29 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric oncologic patients
Key inclusion criteria (1 listed)
- patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h
Key exclusion criteria (3 listed)
- mechanical ventilation less than 24h
- absence of ALI/ARDS criteria
- no neoplasm diagnosis
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
Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated
Time frame: 2y
1 secondary outcome
Epidemiologic data about the selected patients
Time frame: 28 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 13 Mar 2025.
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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.
Rodrigo G Arduini, MD principal investigator
Grupo de Apoio ao Adolescente e a Crianca com Cancer
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 Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
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 1 inclusion and 3 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 13 Mar 2025. 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 Brazil. 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?
Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated (time frame: 2y). 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 Mar 2025.