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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Critically ill children with weight under 10 kilograms undergoing indirect calorimetry1 intervention

Trial outcomes

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.

Time frame
From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)

Secondary outcomes

1

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.

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).
2

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.

Time frame
During PICU stay, at each Q-NRG+ measurement (up to 5 measurements per patient).
3

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.

Time frame
Daily during PICU stay, up to 5 Q-NRG+ measurements per patient.
4

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+.

Time frame
Measurements will be collected from the time of first enrollment until the end of the study (Q2 2026 - Q4 2027).

Other outcomes

1

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

Assessment of rate of successful measurements and patient tolerance when using canopy hood indirect calorimetry in spontaneously breathing patients.

Time frame
During PICU stay, at each attempted canopy hood measurement.

Sponsors and contacts

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