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Could looser jaundice rules spare preterm babies unnecessary treatment?

NCT ID NCT07674537

Disease control Sponsor: University Medical Center Groningen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This trial tests whether using higher (less strict) bilirubin thresholds for starting light therapy in very preterm infants (born before 30 weeks) is as safe as the current Dutch guidelines. About 680 babies across Dutch NICUs will be randomly assigned to one of two threshold strategies. The main goal is to see if the higher thresholds lead to similar rates of survival without developmental problems at age two, while reducing the burden of treatment and monitoring.

What this could mean

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

Active substance
Phototherapy and exchange transfusion thresholds
What this could lead to
If higher thresholds are safe, fewer preterm infants may need intensive light therapy, reducing stress and parent-infant separation.
What could go wrong
This is a non-inferiority trial, so it may only show that the higher thresholds are not worse—not that they are better. Results may not apply outside the Netherlands.

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 680 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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 29 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: * Gestational age at birth \<30+0 weeks. * Admission to a participating NICU within 24 hours after birth. * Parental consent according to the approved consent procedure Exclusion Criteria: * Major congenital anomalies, excluding intraventricular hemorrhage, expected to affect survival or neurodevelopmental outcome. * Antenatal diagnosis of immune hemolytic disease of the fetus or newborn (such as RhD antagonism) requiring protocolized alternative management.

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Conditions

The condition(s) this trial relates to.

hyperbilirubinemia Hyperbilirubinemia, Neonatal Jaundice, Neonatal transient familial neonatal hyperbilirubinemia

As listed by the trial registrant

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

Exchange transfusion Neonatal hyperbilirubinemia Neurodevelopmental outcome Phototherapy Treatment decisions

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

  • Beatrix Children's Hospital, University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.