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Daily massage may ease swelling in preterm infants, small trial hopes

NCT ID NCT07418814

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a daily 15-minute massage for 14 days can reduce swelling (lymphedema) and improve comfort in 40 premature babies in the NICU. Half the infants will receive standard care, and the other half will also get gentle massage on their arms and legs. Researchers will measure changes in limb size and use a comfort scale to see if the massage helps.

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 therapy
What this could lead to
If it works, this could offer a safe, non-drug way to reduce swelling and distress in premature babies in the NICU.
What could go wrong
This is a very small early trial (40 infants) with no blinding, so results may not be reliable or generalizable. The massage may not reduce swelling more than standard care.

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 40 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

28 to 37 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: To ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited: * Clinical diagnosis of lymphedema. * Hemodynamic and clinical stability. * No current or recent (within 24 hours) administration of analgesic or sedative medications that could mask comfort assessments. * Intact skin integrity with no contraindications for topical massage. * Absence of congenital heart disease or neurological disorders (antenatal or postnatal diagnosis). * No immediate requirement for endotracheal aspiration. * Requirement for only non-invasive respiratory support (e.g., nCPAP). * Provision of written informed consent by the legal guardians (parents). Exclusion Criteria: Infants will be excluded if they present with: * Major congenital anomalies. * Severe respiratory, cardiac, or neurological instability during the study period. * Any acute medical contraindication identified by the attending neonatologist.

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Conditions

The condition(s) this trial relates to.

Edema lymphedema Premature Birth

As listed by the trial registrant

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

Edema Immobilization Lymphedema Premature birth

How to take part

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  1. The official record

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