Indirect Calorimetry Measurement in the Pediatric Intensive Care Unit's Smallest Patients

NCT07462806 | Not Yet Recruiting

• 1 other identifier: K 2025-0683
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

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; Metabolic monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  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.

  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

  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.

  During PICU stay, based on repeated Q-NRG+ measurements (up to 5 measurements per patient).

Other Outcomes (1)

• Feasibility of canopy hood indirect calorimetry in non-intubated patients.

  During PICU stay, at each attempted canopy hood measurement.

Study Arms (1)

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.

Device: Q-NRG+

Interventions

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.

Critically ill children with weight under 10 kilograms undergoing indirect calorimetry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Pediatric Perioperative Medicine and Intensive Care Stockholm, Sweden

Stockholm, Solna, 17176, Sweden

Location

Related Publications (14)

• 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.

  PMID: 19335343 BACKGROUND

• Tume 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.

  PMID: 32077997 BACKGROUND

• Mehta 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.

  PMID: 28686844 BACKGROUND

• Karlsson 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.

  PMID: 38270695 BACKGROUND

• Joosten 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.

  PMID: 30585805 BACKGROUND

• Joosten 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.

  PMID: 26963579 BACKGROUND

• Hulst 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.

  PMID: 15723748 BACKGROUND

• Gunst 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.

  PMID: 39947042 BACKGROUND

• Fell 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.

  PMID: 37721466 BACKGROUND

• Fadeur 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.

  PMID: 39961294 BACKGROUND

• Briassoulis 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.

  PMID: 36235803 BACKGROUND

• Alcantara 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.

  PMID: 35180452 BACKGROUND

• Albert 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.

  PMID: 33853268 BACKGROUND

• Albert 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.

  PMID: 35797542 BACKGROUND

Central Study Contacts

Mirjam Larsson, Ass Senior Consultant PhD stud

CONTACT

+46707474628; mirjam.m.larsson@regionstockholm.se

Urban Fläring, Ass prof, senior consultant

CONTACT

+46708763900; urban.flaring@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)