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Tiny tots, big data: new device tracks energy in sick infants

NCT ID NCT07462806

Knowledge-focused Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a device called Q-NRG+ to see if it can accurately measure how much energy critically ill babies under 10 kilograms use. About 80 infants in the pediatric ICU will be observed. The goal is to see if this method works well in very small patients, which could help doctors provide better nutrition and care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric critical illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pediatric Perioperative Medicine and Intensive Care Stockholm, Sweden

    Stockholm, Solna, 17176, Sweden

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