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Gentle touch and voice may ease stress for premature babies — a pilot trial puts it to the test

NCT ID NCT07728760

Symptom relief Sponsor: Gadjah Mada University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This pilot trial tests whether the SENSITIVE Care Program — a 14-day bundle of touch, skin-to-skin care, talking, and eye contact — can lower stress (measured by saliva cortisol) and improve mother-infant interaction for preterm babies in the NICU. Eight clinically stable preterm infants born at 28 to 37 weeks will receive either the program plus standard care or standard care alone. The goal is to see if this gentle, readiness-based approach can make a difference in the high-stress NICU environment.

What this could mean

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

Active substance
SENSITIVE Care Program, a structured sensory-integrative intervention including touch, skin-to-skin care, and parental engagement
What this could lead to
If it works, this program could offer a simple, drug-free way to reduce stress and improve bonding for preterm infants in intensive care.
What could go wrong
This is a very small pilot study with only 8 participants, so results may not apply broadly. The program requires trained staff and parent involvement, which may be hard to scale.

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

8 people

The number who actually took part.

Started

Jun 2026

Finished

Jul 2026

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

3 to 28 days

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: * Preterm infants born at 28 to \<37 weeks of gestation, Admitted to one of the participating NICUs, Chronological age of 3 days or older at enrollment, Clinically stable as determined by the attending neonatologist, Expected to remain hospitalized for at least 14 days, Parent or legal guardian provided written informed consent. Exclusion Criteria: * Major congenital anomalies, chromosomal abnormalities, or genetic syndromes. Congenital oral or facial anomalies interfering with salivary cortisol collection.

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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.

Infant, premature Neonatal intensive care unit (NICU) Preterm infant

Contacts and locations

Locations

  • RSUD Wates, Daerah Istimewa Yogyakarta, Indonesia

    Bantul, DI. Yogyajarta, 55714, Indonesia

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