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A pinprick of blood could Fine-Tune caffeine dosing for preemies

NCT ID NCT07779915

Diagnosis Sponsor: University Hospital, Limoges Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether a small device called Mitra can collect a tiny drop of blood from premature babies to measure caffeine levels. Caffeine is commonly given to preterm infants to prevent apnea, but finding the right dose is tricky—too little may cause breathing pauses, and too much can lead to a fast heart rate. The device could make monitoring easier and less stressful than standard blood draws. The trial will check if the device is practical for nurses and if the results match standard lab tests.

What this could mean

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

Active substance
A microsampling device (Mitra) used to collect a tiny drop of capillary blood for caffeine level testing in premature infants
What this could lead to
If successful, this could enable routine, less-invasive monitoring of caffeine levels in premature infants, potentially reducing the need for larger blood draws and helping tailor dosing to prevent apnea and side effects.
What could go wrong
This is a small pilot study, so results may not be conclusive. The device might not be reliable enough in practice, and there is a risk of sample errors or low nurse satisfaction.

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 40 people

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

Expected to start

Oct 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.

Ages

24 to 34 weeks

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: * Preterm infants born before 34 amenorrhea weeks * Receiving oral or intravenous Caffeine * Requiring capillary blood sample * Having parental signed informed consent of participation in the study * Affiliated to, or beneficiary of, a social security program Exclusion Criteria: * Birth Weight under 500 grams * Age under 24 weeks of amenorrhea.

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Conditions

The condition(s) this trial relates to.

Apnea apnea of prematurity

As listed by the trial registrant

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

Apnea of prematurity

How to take part

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

  1. The places running it

    2 sites. 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

  • Brive Hospital

    Brivé, France, France

  • Limoges Universitary Hospital

    Limoges, France, 87000, France

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