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Skin-to-Skin and Mom's voice may help preemies thrive

NCT ID NCT07045402

Symptom relief Sponsor: Fenerbahce University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tests whether combining kangaroo care (skin-to-skin contact) with a mother's voice and a specific fetal position can improve comfort, growth, and the ability to feed by mouth in preterm infants born at 30-34 weeks. Sixty-eight babies will be split into two groups: one receiving the full intervention and one receiving only the fetal position. Researchers will measure comfort levels, weight gain, and how quickly babies transition from tube feeding to full oral feeding.

What this could mean

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

Active substance
kangaroo care (skin-to-skin contact) combined with maternal storytelling and fetal positioning
What this could lead to
If it works, this could offer a simple, drug-free way to help preterm babies feel more comfortable, grow better, and transition to oral feeding sooner.
What could go wrong
This is a small, early-stage study with only 68 infants, so results may not apply to all preterm babies. The intervention is non-invasive, so risks are minimal, but the benefits may be modest.

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 68 people

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

Started

Feb 2025

Expected to finish

Mar 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

30 to 34 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Infants with a gestational age between 30-34 weeks. 2. The mother's ability to read and write. 3. The infant must be fully enterally fed at the time of enrollment in the study. 4. Infants who are being fed via orogastric tube at the time of enrollment. 5. Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study. 6. Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied. Exclusion Criteria: 1. Presence of a congenital anomaly or genetic disease. 2. Requirement of ventilator support. 3. Infants receiving antibiotics for sepsis or suspected sepsis. 4. Administration of sedative treatment. 5. Having an intracranial hemorrhage greater than grade II. 6. The mother having a physical condition that prevents skin-to-skin contact. 7. The mother using substances or alcohol.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Comfort Facilitated tucking Feeding Infant, premature Kangaroo mother care Oral feeding performance

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

  • Fenerbahce University

    RECRUITING

    Istanbul, Turkey (Türkiye)

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