Can a gentle touch soothe preterm babies on breathing machines?

NCT ID NCT07773896

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial investigates whether infant massage can improve comfort and physiological stability in late preterm infants receiving nCPAP, a form of non-invasive breathing support. Ninety infants will be divided into three groups: one receiving 5-minute massages twice daily, another receiving 10-minute massages twice daily, and a control group receiving standard care only. Researchers will measure comfort levels, heart rate, breathing rate, oxygen saturation, and body temperature before and after each session over three days. The goal is to see if massage, and at what duration, helps these fragile newborns feel better and stay stable.

What this could mean

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

Active substance
Infant massage
What this could lead to
If effective, massage could become a simple, drug-free way to improve comfort and physiological stability in preterm infants on breathing support.
What could go wrong
This is a small, early-stage study, and results may not apply to all preterm infants. Massage must be performed carefully to avoid disturbing the baby's stability.

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 90 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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

1 day to 1 month

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: * Newborns must: * Be between 34⁰/₇ and 36⁶/₇ weeks of gestation, * Be receiving nCPAP support, * Be hemodynamically stable, * Have started enteral feeding, * Have no congenital anomalies, * Their parents must voluntarily agree to participate in the study and provide written informed consent. Exclusion Criteria: * Newborns who: * Are receiving invasive mechanical ventilation, * Have undergone a surgical procedure, * Have a neurological disorder or a serious congenital anomaly, * Are receiving sedatives or neuromuscular blocking agents, * Whose clinical condition is not suitable for massage, * Who have a dermatological condition that could compromise skin integrity or a skin lesion that could interfere with massage, * Who have medical device-related pressure injuries caused by nCPAP.

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Tarsus University

    Mersin, 33400, Turkey (Türkiye)

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