Pediatric Critical IllnessQ-NRG2025NCT07462806
Indirect Calorimetry Measurement in the Pediatric Intensive Care Unit's Smallest Patients
An observational study of Pediatric Critical Illness, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Indirect calorimetry is considered the reference method for measuring energy expenditure in intensive care patients. However, in infants and small children weighing less than 10 kilograms, its clinical use has historically been limited due to technical challenges related to low tidal volumes, potential increases in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Critical Illness
- What is being tested?
- Q-NRG+
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of critically ill infants and children weighing 0.5-10 kg who are admitted to a pediatric intensive care unit and require mechanical ventilation or are spontaneously breathing and eligible for indirect calorimetry measurement. Participants are recruited consecutively during the study period (Q2 2026-Q4 2027).
Who may be able to join
None listed.
Who cannot join
- In mechanically ventilated patients' unstable ventilation including ventilation settings changed during the last 60 minutes (FiO2 >70%, PIP>30 cmH2O, or ventilation system leakage). Patients spontaneous breathing not tolerating measurements with canopy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mirjam Larsson, Ass Senior Consultant PhD stud contact
Sweden1 site
Pediatric Perioperative Medicine and Intensive Care Stockholm, Sweden
Stockholm, Solna, 17176
Urban Fläring, Ass prof, senior consultant, +46708763900, urban.flaring@ki.se
About this study
Official title: Indirect Calorimetry Measurement in the Paediatric Intensive Care Unit's Smallest Patients
Indirect calorimetry is considered the reference method for measuring energy expenditure in intensive care patients. However, in infants and small children weighing less than 10 kilograms, its clinical use has historically been limited due to technical challenges related to low tidal volumes, potential increases in dead space, and measurement precision.
The goal of this observational study is to evaluate the feasibility and performance of indirect calorimetry using the Q-NRG+ device in critically ill children weighing less than 10 kg who are admitted to a pediatric intensive care unit.
Read the detailed description
Indirect calorimetry measures oxygen consumption and carbon dioxide production to calculate resting energy expenditure and is considered the reference method in intensive care. In mechanically ventilated pediatric patients, resting energy expenditure is commonly used as a surrogate for total energy expenditure, as activity-related expenditure is minimal due to sedation and ventilation. Despite its clinical relevance, the use of indirect calorimetry in children weighing less than 10 kg has been limited by technical challenges related to low tidal volumes and measurement precision. The Q-NRG+ is an indirect calorimeter designed to measure resting energy expenditure in mechanically ventilated and spontaneously breathing patients.
This prospective, single-center observational study will be conducted in a pediatric intensive care unit. Critically ill children weighing less than 10 kg who require mechanical ventilation or are spontaneously breathing and able to tolerate indirect calorimetry measurement using a canopy hood will be eligible for inclusion. Indirect calorimetry measurements will be performed according to a predefined protocol during the course of critical illness. For the measurement, a sampling module will be connected to the ventilator circuit without increasing ventilator dead space. The system continuously samples inspired and expired gases, and energy expenditure is calculated based on measured oxygen consumption and carbon dioxide production in combination with ventilator parameters.
The primary objective is to evaluate the feasibility of indirect calorimetry using the Q-NRG+ in critically ill children weighing less than 10 kg, defined as the proportion of technically valid and clinically interpretable measurements. Secondary objectives are to describe measured resting energy expenditure (kcal/kg/day) in this population, to evaluate changes in measured energy expenditure over the course of critical illness, and to compare measured energy expenditure with predicted energy requirements calculated using standard predictive equations. Demographic and clinical variables relevant to metabolic status (age, weight, diagnosis, ventilator settings, sedation, and phase of illness) will be collected from medical records. Descriptive and comparative statistical analyses will be performed.
- Conditions
- Pediatric Critical Illness
- Being tested
- Q-NRG+
- Keywords
- Pediatric Critical Illness, weight under 10 kilogram, Indirect calorimetry, Energy expenditure, Nutritional assessment, Q-NRG+, Pediatric intensive care, chofield equation, Metabolic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-NRG+Device
The Q-NRG+ is an indirect calorimetry device used to measure resting energy expenditure in mechanically ventilated or spontaneously breathing patients. In this study, the device is connected to the ventilator circuit or used with a canopy hood to measure oxygen consumption and carbon dioxide production for calculation of energy expenditure. Measurements are performed in addition to standard clinical care and do not alter routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill children with weight under 10 kilograms undergoing indirect calorimetry | This cohort includes critically ill children weighing less than 10 kilograms who are admitted to a pediatric intensive care unit. Participants undergo indirect calorimetry measurements using the Q-NRG+ device in addition to standard clinical care. Measured energy expenditure is recorded and analyzed without altering routine treatment. Receives: Device: Q-NRG+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Q-NRG+ indirect calorimetry measurements
Feasibility is defined as the proportion of attempted Q-NRG+ measurements in infants weighing 0.5-10 kg that result in technically valid and clinically interpretable data according to predefined quality criteria (i) variability <10% over a 15-minute period with constant Vt/MV (tidal volume/minute ventilation) and (ii) respiratory Quotient (RQ) within the range of </=1 or >/=0.7.
Measured: From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)
Secondary outcomes (5)
Agreement between carbon dioxide production measured by Q-NRG+ and volumetric capnography, Capnostat 5
Comparison of carbon dioxide production measured using the Q-NRG+ device with obtained via other volumetric capnography already used in the clinic when available.
Measured: During PICU stay (Day 1 to Day 7), when simultaneous Q-NRG+ and Capnostat 5 measurements are available (up to 5 measurements per patient).
Agreement between measured resting energy expenditure and predicted through Schofield equation.
Comparison between resting energy expenditure measured by Q-NRG+ and estimated using the Schofield equation, commonly used in peadiatric intensive care units.
Measured: During PICU stay, at each Q-NRG+ measurement (up to 5 measurements per patient).
Change in measured resting energy expenditure across phases of critical illness.
Evaluation of variation in measured REE during acute, stable, and recovery phases of critical illness.
Measured: Daily during PICU stay, up to 5 Q-NRG+ measurements per patient.
Agreement between oxygen consumtion and carbondioxid production derived from blood gas respiratory quotient and Q-NRG+ measurements
Comparison between oxygen consumtion and carbondioxid production calculated from blood gas central venous and arteriall and measured using Q-NRG+.
Measured: Measurements will be collected from the time of first enrollment until the end of the study (Q2 2026 - Q4 2027).
Development of predictive model for resting energy expenditure in critically ill children under 10 kilograms.
Exploratory analysis to develop predictive equations for REE based on repeated Q-NRG+ measurements.
Measured: During PICU stay, based on repeated Q-NRG+ measurements (up to 5 measurements per patient).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pediatric Critical IllnessStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urban Fläring, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462806
- Sponsor's protocol ID
- K 2025-0683
- Acronym
- Q-NRG2025
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flaring U, Finkel Y. Nutritional support to patients within the pediatric intensive setting. Paediatr Anaesth. 2009 Apr;19(4):300-12. doi: 10.1111/j.1460-9592.2009.02954.x. No abstract available.
PubMed 19335343Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.
PubMed 32077997Mehta NM, Skillman HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, McKeever L, Hall AM, Goday PS, Braunschweig C. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Pediatric Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):706-742. doi: 10.1177/0148607117711387. Epub 2017 Jun 2.
PubMed 28686844Karlsson J, Svedmyr A, Wallin M, Hallback M, Lonnqvist PA. Validation of an alternative technique for RQ estimation in anesthetized pigs. Intensive Care Med Exp. 2024 Jan 25;12(1):11. doi: 10.1186/s40635-024-00598-8.
PubMed 38270695Joosten KFM, Eveleens RD, Verbruggen SCAT. Nutritional support in the recovery phase of critically ill children. Curr Opin Clin Nutr Metab Care. 2019 Mar;22(2):152-158. doi: 10.1097/MCO.0000000000000549.
PubMed 30585805Joosten KF, Kerklaan D, Verbruggen SC. Nutritional support and the role of the stress response in critically ill children. Curr Opin Clin Nutr Metab Care. 2016 May;19(3):226-33. doi: 10.1097/MCO.0000000000000268.
PubMed 26963579Hulst JM, van Goudoever JB, Zimmermann LJ, Hop WC, Buller HA, Tibboel D, Joosten KF. Adequate feeding and the usefulness of the respiratory quotient in critically ill children. Nutrition. 2005 Feb;21(2):192-8. doi: 10.1016/j.nut.2004.05.020.
PubMed 15723748Gunst J, Vanhorebeek I, Verbruggen SC, Dulfer K, Joosten KF, Van den Berghe G. On how to feed critically ill children in intensive care: A slowly shifting paradigm. Clin Nutr. 2025 Mar;46:169-180. doi: 10.1016/j.clnu.2025.02.003. Epub 2025 Feb 6.
PubMed 39947042Fell DM, Bitetto EA, Skillman HE. Timing of enteral nutrition and parenteral nutrition in the PICU. Nutr Clin Pract. 2023 Oct;38 Suppl 2:S174-S212. doi: 10.1002/ncp.11050.
PubMed 37721466Fadeur M, Kaux JF, De Flines J, Misset B, Paquot N, Rousseau AF. Indirect calorimetry in canopy mode in healthy subjects: performances of the Q-NRG device compared to the Deltatrac II. Acta Gastroenterol Belg. 2025 Jan-Mar;88(1):13-17. doi: 10.51821/88.1.13301.
PubMed 39961294Briassoulis G, Briassouli E, Ilia S, Briassoulis P. External Validation of Equations to Estimate Resting Energy Expenditure in Critically Ill Children and Adolescents with and without Malnutrition: A Cross-Sectional Study. Nutrients. 2022 Oct 6;14(19):4149. doi: 10.3390/nu14194149.
PubMed 36235803Alcantara JMA, Galgani JE, Jurado-Fasoli L, Dote-Montero M, Merchan-Ramirez E, Ravussin E, Ruiz JR, Sanchez-Delgado G. Validity of four commercially available metabolic carts for assessing resting metabolic rate and respiratory exchange ratio in non-ventilated humans. Clin Nutr. 2022 Mar;41(3):746-754. doi: 10.1016/j.clnu.2022.01.031. Epub 2022 Feb 4.
PubMed 35180452Albert BD, Spolidoro GC, Mehta NM. Metabolism and energy prescription in critically ill children. Minerva Anestesiol. 2021 Sep;87(9):1025-1033. doi: 10.23736/S0375-9393.21.14825-4. Epub 2021 Apr 14.
PubMed 33853268Albert BD, Martinez EE. Challenges and advances in nutrition for the critically ill child. Curr Opin Crit Care. 2022 Aug 1;28(4):401-408. doi: 10.1097/MCC.0000000000000953. Epub 2022 Jul 5.
PubMed 35797542
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Calorimetry Measurement in the Paediatric Intensive Care Unit's Smallest Patients
- ClinicalTrials.gov ID
- NCT07462806
- Acronym / sponsor ID
- Q-NRG2025 / K 2025-0683
- Conditions
- Pediatric Critical Illness
- Keywords
- Pediatric Critical Illness, weight under 10 kilogram, Indirect calorimetry, Energy expenditure, Nutritional assessment, Q-NRG+, Pediatric intensive care, chofield equation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
Indirect calorimetry is considered the reference method for measuring energy expenditure in intensive care patients. However, in infants and small children weighing less than 10 kilograms, its clinical use has historically been limited due to technical challenges related to low tidal volumes, potential increases in dead space, and measurement precision.
The goal of this observational study is to evaluate the feasibility and performance of indirect calorimetry using the Q-NRG+ device in critically ill children weighing less than 10 kg who are admitted to a pediatric intensive care unit.
Detailed description
Indirect calorimetry measures oxygen consumption and carbon dioxide production to calculate resting energy expenditure and is considered the reference method in intensive care. In mechanically ventilated pediatric patients, resting energy expenditure is commonly used as a surrogate for total energy expenditure, as activity-related expenditure is minimal due to sedation and ventilation. Despite its clinical relevance, the use of indirect calorimetry in children weighing less than 10 kg has been limited by technical challenges related to low tidal volumes and measurement precision. The Q-NRG+ is an indirect calorimeter designed to measure resting energy expenditure in mechanically ventilated and spontaneously breathing patients.
This prospective, single-center observational study will be conducted in a pediatric intensive care unit. Critically ill children weighing less than 10 kg who require mechanical ventilation or are spontaneously breathing and able to tolerate indirect calorimetry measurement using a canopy hood will be eligible for inclusion. Indirect calorimetry measurements will be performed according to a predefined protocol during the course of critical illness. For the measurement, a sampling module will be connected to the ventilator circuit without increasing ventilator dead space. The system continuously samples inspired and expired gases, and energy expenditure is calculated based on measured oxygen consumption and carbon dioxide production in combination with ventilator parameters.
The primary objective is to evaluate the feasibility of indirect calorimetry using the Q-NRG+ in critically ill children weighing less than 10 kg, defined as the proportion of technically valid and clinically interpretable measurements. Secondary objectives are to describe measured resting energy expenditure (kcal/kg/day) in this population, to evaluate changes in measured energy expenditure over the course of critical illness, and to compare measured energy expenditure with predicted energy requirements calculated using standard predictive equations. Demographic and clinical variables relevant to metabolic status (age, weight, diagnosis, ventilator settings, sedation, and phase of illness) will be collected from medical records. Descriptive and comparative statistical analyses will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill children with weight under 10 kilograms undergoing indirect calorimetry | – | Device: Q-NRG+This cohort includes critically ill children weighing less than 10 kilograms who are admitted to a pediatric intensive care unit. Participants undergo indirect calorimetry measurements using the Q-NRG+ device in addition to standard clinical care. Measured energy expenditure is recorded and analyzed without altering routine treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of critically ill infants and children weighing 0.5-10 kg who are admitted to a pediatric intensive care unit and require mechanical ventilation or are spontaneously breathing and eligible for indirect calorimetry measurement. Participants are recruited consecutively during the study period (Q2 2026-Q4 2027).
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- In mechanically ventilated patients' unstable ventilation including ventilation settings changed during the last 60 minutes (FiO2 >70%, PIP>30 cmH2O, or ventilation system leakage). Patients spontaneous breathing not tolerating measurements with canopy.
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 |
|---|---|---|
| Q-NRG+The Q-NRG+ is an indirect calorimetry device used to measure resting energy expenditure in mechanically ventilated or spontaneously breathing patients. In this study, the device is connected to the ventilator circuit or used with a canopy hood to measure oxygen consumption and carbon dioxide production for calculation of energy expenditure. Measurements are performed in addition to standard clinical care and do not alter routine treatment. | Device | Critically ill children with weight under 10 kilograms undergoing indirect calorimetry |
Primary outcome
Feasibility of Q-NRG+ indirect calorimetry measurements
Time frame: From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)
Feasibility is defined as the proportion of attempted Q-NRG+ measurements in infants weighing 0.5-10 kg that result in technically valid and clinically interpretable data according to predefined quality criteria (i) variability <10% over a 15-minute period with constant Vt/MV (tidal volume/minute ventilation) and (ii) respiratory Quotient (RQ) within the range of </=1 or >/=0.7.
5 secondary outcomes
Agreement between carbon dioxide production measured by Q-NRG+ and volumetric capnography, Capnostat 5
Time frame: During PICU stay (Day 1 to Day 7), when simultaneous Q-NRG+ and Capnostat 5 measurements are available (up to 5 measurements per patient).
Agreement between measured resting energy expenditure and predicted through Schofield equation.
Time frame: During PICU stay, at each Q-NRG+ measurement (up to 5 measurements per patient).
Change in measured resting energy expenditure across phases of critical illness.
Time frame: Daily during PICU stay, up to 5 Q-NRG+ measurements per patient.
Agreement between oxygen consumtion and carbondioxid production derived from blood gas respiratory quotient and Q-NRG+ measurements
Time frame: Measurements will be collected from the time of first enrollment until the end of the study (Q2 2026 - Q4 2027).
Development of predictive model for resting energy expenditure in critically ill children under 10 kilograms.
Time frame: During PICU stay, based on repeated Q-NRG+ measurements (up to 5 measurements per patient).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 19335343Flaring U, Finkel Y. Nutritional support to patients within the pediatric intensive setting. Paediatr Anaesth. 2009 Apr;19(4):300-12. doi: 10.1111/j.1460-9592.2009.02954.x. No abstract available.
- Background: PubMed 32077997Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.
- Background: PubMed 28686844Mehta NM, Skillman HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, McKeever L, Hall AM, Goday PS, Braunschweig C. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Pediatric Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):706-742. doi: 10.1177/0148607117711387. Epub 2017 Jun 2.
- Background: PubMed 38270695Karlsson J, Svedmyr A, Wallin M, Hallback M, Lonnqvist PA. Validation of an alternative technique for RQ estimation in anesthetized pigs. Intensive Care Med Exp. 2024 Jan 25;12(1):11. doi: 10.1186/s40635-024-00598-8.
- Background: PubMed 30585805Joosten KFM, Eveleens RD, Verbruggen SCAT. Nutritional support in the recovery phase of critically ill children. Curr Opin Clin Nutr Metab Care. 2019 Mar;22(2):152-158. doi: 10.1097/MCO.0000000000000549.
- Background: PubMed 26963579Joosten KF, Kerklaan D, Verbruggen SC. Nutritional support and the role of the stress response in critically ill children. Curr Opin Clin Nutr Metab Care. 2016 May;19(3):226-33. doi: 10.1097/MCO.0000000000000268.
- Background: PubMed 15723748Hulst JM, van Goudoever JB, Zimmermann LJ, Hop WC, Buller HA, Tibboel D, Joosten KF. Adequate feeding and the usefulness of the respiratory quotient in critically ill children. Nutrition. 2005 Feb;21(2):192-8. doi: 10.1016/j.nut.2004.05.020.
- Background: PubMed 39947042Gunst J, Vanhorebeek I, Verbruggen SC, Dulfer K, Joosten KF, Van den Berghe G. On how to feed critically ill children in intensive care: A slowly shifting paradigm. Clin Nutr. 2025 Mar;46:169-180. doi: 10.1016/j.clnu.2025.02.003. Epub 2025 Feb 6.
- Background: PubMed 37721466Fell DM, Bitetto EA, Skillman HE. Timing of enteral nutrition and parenteral nutrition in the PICU. Nutr Clin Pract. 2023 Oct;38 Suppl 2:S174-S212. doi: 10.1002/ncp.11050.
- Background: PubMed 39961294Fadeur M, Kaux JF, De Flines J, Misset B, Paquot N, Rousseau AF. Indirect calorimetry in canopy mode in healthy subjects: performances of the Q-NRG device compared to the Deltatrac II. Acta Gastroenterol Belg. 2025 Jan-Mar;88(1):13-17. doi: 10.51821/88.1.13301.
- Background: PubMed 36235803Briassoulis G, Briassouli E, Ilia S, Briassoulis P. External Validation of Equations to Estimate Resting Energy Expenditure in Critically Ill Children and Adolescents with and without Malnutrition: A Cross-Sectional Study. Nutrients. 2022 Oct 6;14(19):4149. doi: 10.3390/nu14194149.
- Background: PubMed 35180452Alcantara JMA, Galgani JE, Jurado-Fasoli L, Dote-Montero M, Merchan-Ramirez E, Ravussin E, Ruiz JR, Sanchez-Delgado G. Validity of four commercially available metabolic carts for assessing resting metabolic rate and respiratory exchange ratio in non-ventilated humans. Clin Nutr. 2022 Mar;41(3):746-754. doi: 10.1016/j.clnu.2022.01.031. Epub 2022 Feb 4.
- Individual participant dataSharing planned: No
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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.
Mirjam Larsson, Ass Senior Consultant PhD stud contact
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 Pediatric Critical Illness, run by Karolinska Institutet at 1 site in Sweden.
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 0 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Larsson, Ass Senior Consultant PhD stud (+46707474628, mirjam.m.larsson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Q-NRG+ indirect calorimetry measurements (time frame: From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)). 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 NCT07462806, which also lists 14 linked publications.
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 10 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.