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New study to check if jaundice device misses Darker-Skinned babies

NCT ID NCT07315126

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will check if a standard jaundice test (a light meter on the skin) works equally well for newborns of all skin colors. About 510 babies will have their skin color classified and their jaundice levels measured both with the meter and a blood test. The goal is to see if the meter is less accurate for babies with darker skin, which could lead to missed cases of dangerous jaundice.

What this could mean

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

What this could lead to
If successful, this could lead to more accurate jaundice screening for newborns with darker skin, reducing missed cases.
What could go wrong
This is an observational study, not a treatment trial. It only measures accuracy, so it won't directly improve health outcomes.

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 510 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

Newborns from 36 weeks of amenorrhea hospitalized in the postnatal ward or in the kangaroo unit within the Port-Royal maternity.

Ages

1 hour 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: * Born from 36 weeks of amenorrhea * Hospitalized in the postnatal ward or kangaroo care unit * Requiring a blood test for bilirubin analysed at the Cochin laboratory. * No objection from both holders of parental authority. Exclusion Criteria: * Having received phototherapy treatment within the last 24 hours

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Conditions

The condition(s) this trial relates to.

bilirubin encephalopathy Jaundice, Neonatal

As listed by the trial registrant

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

Neonatal jaundice

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

  • Maternité Port Royal

    Paris, 75014, France

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