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Could a Mother's scent soothe preemies on ventilators? new study tests gentle comfort methods

NCT ID NCT07681934

Symptom relief Sponsor: KTO Karatay 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Jul 02, 2026

Summary

This study investigates whether safe swaddling and the scent of breast milk can improve comfort and reduce stress in premature newborns who need mechanical breathing support. Researchers will measure babies' heart rate, stress levels, and comfort scores during these gentle interventions. The goal is to find simple, non-drug ways to help these fragile infants feel better and potentially recover faster.

What this could mean

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

Active substance
safe swaddling method and breast milk scent
What this could lead to
If effective, these simple, drug-free techniques could improve comfort and reduce stress for premature babies on breathing support, potentially shortening hospital stays.
What could go wrong
This is a small, early-stage study (72 babies) testing short-term effects. Results may not apply to all preemies, and the benefits might be modest or not statistically significant.

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

72 people

The number who actually took part.

Started

Jun 2024

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

34 to 36 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: * Newborns with gestational weeks between 340/7-366/7, * In the first 28 days of life, * High-flow nasal cannula applied, * Birth weight 1500 gr and above, * Breastfeeding mothers, * No health problems that would prevent positioning, Exclusion Criteria: * Those who have had a painful procedure within the last hour, * Those who have taken analgesic/sedative drugs within the last 6 hours, * Those who have undergone any surgical intervention, * Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.), * Those with cerebral hypoxia/ischemia, * Those with intraventricular hemorrhage, * Newborns with congenital anomalies

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Conditions

The condition(s) this trial relates to.

Dyspnea Premature Birth

As listed by the trial registrant

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

Prematurity, mechanical ventilation

Contacts and locations

Locations

  • KTO Karatay University

    Konya, Karatay, 42040, Turkey (Türkiye)