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Could a simple hat make jaundice treatment kinder for newborns?

NCT ID NCT07690930

Symptom relief Sponsor: Karamanoğlu Mehmetbey University 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tests whether a special hat with built-in goggles can make phototherapy more comfortable for full-term newborns with jaundice, compared to standard eye patches. Researchers will measure the babies' comfort levels, bilirubin changes, treatment duration, and parental satisfaction. The trial involves 24 newborns in a single hospital, so results are preliminary.

What this could mean

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

Active substance
Hat-with-Goggles Eye Protection Device
What this could lead to
If effective, this simple device could make phototherapy more comfortable for newborns and more satisfying for parents, potentially reducing treatment duration.
What could go wrong
This is a small, single-center study with only 24 participants, so results may not apply broadly. The device can only be used in certain settings, and the trial may not show significant benefits.

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 24 people

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

Started

Aug 2025

Expected to finish

Aug 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.

Ages

0 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: * Inclusion Criteria * Being a term newborn (38-42 gestational weeks) * Having an Apgar score of 7-10 * Being hospitalized in a primary care setting and in a cot bed Exclusion Criteria: * Hospitalization with a diagnosis of pathological jaundice * Presence of congenital anomalies in the newborn * Mothers having a condition that may prevent them from completing the questionnaire (such as language barriers) or having a communication impairment * Parents not wanting their newborn to participate in the study, or wishing to withdraw during the course of the study

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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 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

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Karaman Training and Research Hospital

    Karaman, Turkey (Türkiye)

  • Karamanoğlu Mehmetbey Üniversitesi

    Karaman, Turkey (Türkiye)

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