Indirect Calorimetry Measurement in the Pediatric Intensive Care Unit's Smallest Patients (NCT07462806) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Indirect Calorimetry Measurement in the Pediatric Intensive Care Unit's Smallest Patients
Sweden80 participantsStarted 2026-04
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Q-NRG+ indirect calorimetry measurements
Timeframe: From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)