Respiratory Insufficiency in ChildrenCALO-NIVNCT03824249
Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation
A study testing Indirect Calorimetry in people with Respiratory Insufficiency in Children and Noninvasive Ventilation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Respiratory Insufficiency in Children, Noninvasive Ventilation, Nutrition Assessment
- What is being tested?
- Indirect Calorimetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2019to 15 Dec 2021
- 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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children admitted to the Pediatric Intensive Care Unit who completed the weaning phase from non-invasive ventilation.
- age ≤ 6 years
- patients whose parents provided signed informed consent
Who cannot join
- age > 6 years
- patients whose parents didn't provide signed informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study
Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. For this reason, actual measurement of resting energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better approach.
Currently, IC is not validated during the use of non-invasive ventilation.
Aim of the present study is to validate the measurement of REE with IC in pediatric patients undergoing non-invasive ventilation through a single-limb circuit with intentional leak.
- Being tested
- Indirect Calorimetry
- Keywords
- Energy Expenditure, Ventilator Weaning, Calorimetry, indirect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryDiagnostic test
Also called IC
Performance of indirect calorimetry in Canopy mode.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing | Experimental | Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry. Receives: Diagnostic Test: Indirect Calorimetry |
| NIV-CPAP | Experimental | Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 centimeters of water (cmH2O). CPAP will be applied via single-limb circuit with intentional leak. Receives: Diagnostic Test: Indirect Calorimetry |
| NIV-PS | Experimental | Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 cmH2O and Pressure support (PS) of 8 cmH2O. Non-invasive ventilation will be applied via single-limb circuit with intentional leak. Receives: Diagnostic Test: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure (REE)
Resting energy expenditure expressed in kcal/kg/die
Measured: 1 day
Secondary outcomes (3)
Carbon dioxide production (VCO2)
Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min]
Measured: 1 day
Oxygen consumption (VO2)
Quantity of oxygen consumed by the patients [expressed in ml/kg/min]
Measured: 1 day
Respiratory quotient (RQ)
Respiratory quotient [expressed as VCO2/VO2]
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start10 Feb 2019
- Primary completion15 Feb 2020
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency in ChildrenStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Langer, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di MilanoEdoardo Calderini, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di MilanoCarlo Agostoni, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824249
- Sponsor's protocol ID
- 2019/834
- Acronym
- CALO-NIV
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2019
- Last updated
- 4 Mar 2022
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study
- ClinicalTrials.gov ID
- NCT03824249
- Acronym / sponsor ID
- CALO-NIV / 2019/834
- Keywords
- Energy Expenditure, Ventilator Weaning, Calorimetry, indirect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 31 Jan 2019 (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.
Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. For this reason, actual measurement of resting energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better approach.
Currently, IC is not validated during the use of non-invasive ventilation.
Aim of the present study is to validate the measurement of REE with IC in pediatric patients undergoing non-invasive ventilation through a single-limb circuit with intentional leak.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing | Experimental | Diagnostic Test: Indirect CalorimetryPerformance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry. |
| NIV-CPAP | Experimental | Diagnostic Test: Indirect CalorimetryPerformance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 centimeters of water (cmH2O). CPAP will be applied via single-limb circuit with intentional leak. |
| NIV-PS | Experimental | Diagnostic Test: Indirect CalorimetryPerformance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 cmH2O and Pressure support (PS) of 8 cmH2O. Non-invasive ventilation will be applied via single-limb circuit with intentional leak. |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children admitted to the Pediatric Intensive Care Unit who completed the weaning phase from non-invasive ventilation.
- age ≤ 6 years
- patients whose parents provided signed informed consent
Key exclusion criteria (2 listed)
- age > 6 years
- patients whose parents didn't provide signed informed consent
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 |
|---|---|---|
| Indirect CalorimetryAlso: ICPerformance of indirect calorimetry in Canopy mode. | Diagnostic test | NIV-CPAP, NIV-PS, Spontaneous breathing |
Primary outcome
Resting energy expenditure (REE)
Time frame: 1 day
Resting energy expenditure expressed in kcal/kg/die
3 secondary outcomes
Carbon dioxide production (VCO2)
Time frame: 1 day
Oxygen consumption (VO2)
Time frame: 1 day
Respiratory quotient (RQ)
Time frame: 1 day
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 4 Mar 2022.
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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.
Thomas Langer, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Edoardo Calderini, MD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Carlo Agostoni, MD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry in people with Respiratory Insufficiency in Children and Noninvasive Ventilation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 3 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 4 Mar 2022. 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 Italy. 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?
Resting energy expenditure (REE) (time frame: 1 day). 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 4 Mar 2022.