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New study seeks to predict which newborns need repeat jaundice treatment

NCT ID NCT07694635

Knowledge-focused Sponsor: Haseki Training and Research Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study follows 300 newborns treated with light therapy for jaundice to find clues that predict whether jaundice will come back. Researchers will check blood bilirubin levels, feeding patterns, and other factors. The goal is to help doctors decide when it's safe to stop treatment and send babies home without needing another hospital stay.

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 help doctors identify which newborns are at risk for jaundice returning after light therapy, allowing safer discharge and fewer repeat treatments.
What could go wrong
This is an observational study, so it does not test a new treatment. The findings may not apply to all hospitals or newborns, and the predictors identified may not be strong enough to change practice.

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 300 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

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 neonates admitted to the NICU for neonatal hyperbilirubinemia and treated with phototherapy according to institutional protocols and current guideline-based phototherapy thresholds. Both standard and intensive phototherapy modalities may be used based on bilirubin levels, gestational age, and neurotoxicity risk factors. Eligible neonates will be prospectively followed after discontinuation of phototherapy for evaluation of rebound hyperbilirubinemia and repeat phototherapy requirement. Clinical, laboratory, hemolytic, feeding-related, and phototherapy-related variables will be recorded and analyzed to identify predictors of clinically significant rebound hyperbilirubinemia.

Ages

2 hours to 28 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: * Neonates admitted to the NICU with neonatal hyperbilirubinemia * Gestational age ≥35 weeks * Requirement for phototherapy according to institutional protocol and current guideline-based phototherapy thresholds * Receipt of standard and/or intensive phototherapy * Availability of bilirubin measurements before, during, and after phototherapy * Availability of rebound bilirubin measurement within 48 hours after phototherapy discontinuation * Written informed consent obtained from parents or legal guardians, if required by the ethics committee Exclusion Criteria: * Major congenital anomalies * Conjugated hyperbilirubinemia * Neonates requiring exchange transfusion before completion of initial phototherapy * Severe perinatal asphyxia * Proven or suspected inborn errors of metabolism affecting bilirubin metabolism * Significant congenital liver disease * Neonates transferred to another center before completion of rebound bilirubin follow-up * Missing or incomplete clinical or laboratory data * Absence of rebound bilirubin measurement within 48 hours after phototherapy discontinuation * Parents or legal guardians declining participation, if consent is required

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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.

Neonatal hyperbilirubinemia Rebound hyperbilirubinemia

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

  • University of Health Sciences, Haseki Training and Research Hospital

    Istanbul, Sultangazi, 34265, Turkey (Türkiye)

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