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Breast milk pacifier may soothe painful eye exams for preemies

NCT ID NCT07334652

Symptom relief Sponsor: Ataturk 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving premature babies a pacifier dipped in breast milk during eye exams for retinopathy of prematurity can reduce pain and improve comfort. About 56 infants born before 32 weeks will be randomly assigned to receive either standard care or the pacifier. Researchers will measure pain and comfort using special scales and video recordings.

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 56 people

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

Started

Jan 2025

Expected to finish

Feb 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 months to 1 month

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 ≤ 32 weeks * Birth weight ≤ 2000 grams * Infants undergoing their first ROP examination * Spontaneous breathing, not intubated, * Not receiving sedation * No congenital defects, * No unexplained crying, * No surgical intervention, * Parents' consent to participate in the study Exclusion Criteria: * The presence of a condition that prevents pain assessment (intracranial haemorrhage, neurodevelopmental delay, etc.) * A different painful procedure performed prior to ROP (one hour) * Being on mechanical ventilation * Administration of sedative, analgesic, and anticonvulsant medication prior to examination

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Conditions

The condition(s) this trial relates to.

Premature Birth retinopathy of prematurity

As listed by the trial registrant

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

Premature Retinopaty 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

    1 site. 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

  • Ataturk University Faculty of Nursing

    Erzurum, Yakutiye, Turkey (Türkiye)

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