Indirect Calorimetry Measurement in the Pediatric Intensive Care Unit's Smallest Patients (Q-NRG2025)

March 5, 2026 updated by: Urban Fläring, Karolinska Institutet

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Urban Fläring, Ass prof, senior consultant
  • Phone Number: +46708763900
  • Email: urban.flaring@ki.se

Study Locations

  • Sweden
    • Solna
      • Stockholm, Solna, Sweden, 17176
        • Pediatric Perioperative Medicine and Intensive Care Stockholm, Sweden
        • Contact:
          • Urban Fläring, Ass prof, senior consultant
          • Phone Number: +46708763900
          • Email: urban.flaring@ki.se

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria: Newborns and infants admitted to the PICU with body weight from 0,5 up to 10 kilograms. Either requiring mechanically ventilation, with FiO2 < 70%, PIP<30 cmH2O and no leakage in the ventilation system. Or spontaneous breathing patients tolerating measurements with canopy.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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+
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Comparison of carbon dioxide production measured using the Q-NRG+ device with obtained via other volumetric capnography already used in the clinic when available.
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).
Comparison between resting energy expenditure measured by Q-NRG+ and estimated using the Schofield equation, commonly used in peadiatric intensive care units.
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.
Evaluation of variation in measured REE during acute, stable, and recovery 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
Time Frame: Measurements will be collected from the time of first enrollment until the end of the study (Q2 2026 - Q4 2027).
Comparison between oxygen consumtion and carbondioxid production calculated from blood gas central venous and arteriall and measured using Q-NRG+.
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).
Exploratory analysis to develop predictive equations for REE based on repeated Q-NRG+ measurements.
During PICU stay, based on repeated Q-NRG+ measurements (up to 5 measurements per patient).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of canopy hood indirect calorimetry in non-intubated patients.
Time Frame: During PICU stay, at each attempted canopy hood measurement.
Assessment of rate of successful measurements and patient tolerance when using canopy hood indirect calorimetry in spontaneously breathing patients.
During PICU stay, at each attempted canopy hood measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K 2025-0683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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