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New device could help save preterm babies by spotting oxygen drops

NCT ID NCT05278247

Diagnosis Sponsor: Carag AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new light-based monitor (NIRS) that checks oxygen levels in the abdomen of preterm infants. Researchers want to see if it works reliably and safely on 50 babies born before 35 weeks. If it does, it could help doctors quickly detect life-threatening gut problems like NEC.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NIRS device (near-infrared spectroscopy monitor)
What this could lead to
If successful, this could provide a safer, more reliable way to monitor oxygen levels in preterm infants, helping doctors catch dangerous conditions earlier.
What could go wrong
This is an early-stage study with only 50 infants, focused on device performance rather than health outcomes. The device may not work as expected or may cause skin irritation.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 day to 7 days

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: 1. Preterm infants with Gestational age less than 35 0/7 weeks 2. Signed Informed consent of the legal representative(s) is received after being informed. The consent form is signed by one legal representative, which is likely to be either the mother or the father. Only married fathers or those listed on the birth certificate are considered under UK regulations. In the case of non-married father, the mother must provide consent. 3. Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement. Exclusion Criteria: 1. Injured, hypersensitive or bruised skin present on the abdomen, 2. Existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation, 3. Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors, 4. Severe Congenital malformations, 5. Clinical abdominal concerns 6. Severe metabolic disorders, 7. Early onset sepsis, 8. Inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language, 9. The treatment of newborn jaundice with light during measurement time phase 1 and 2, 10. Previous enrolment into the current study, 11. Family members, employees and other dependent persons of the investigator, 12. Participation in another study with investigational drug/device within the preceding days and during the present study which may influence abdominal oxygen saturation. 13. Known silicone allergy

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Conditions

The condition(s) this trial relates to.

neuroendocrine carcinoma

As listed by the trial registrant

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

NEC

How to take part

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  1. 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 ↗

  2. A doctor treating you

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