Soothing sounds: a simple audio may help Low-Birth-Weight babies thrive

NCT ID NCT07774793

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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 Results may not be published yet.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
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Status unknown
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First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether listening to a 15-minute relaxation audio during breastfeeding, twice daily for 12 weeks, can improve weight gain in low-birth-weight newborns and reduce maternal stress and anxiety. Mothers of stable infants born under 2500 grams will be randomly assigned to receive either the relaxation audio or a control device without audio. Researchers will track infant growth and maternal well-being over 12 weeks to see if this simple intervention makes a difference.

What this could mean

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

Active substance
A 15-minute relaxation audiorecording supportive of breastfeeding, listened to twice daily during breastfeeding for 12 weeks.
What this could lead to
If effective, this simple, low-cost intervention could offer a practical way to improve growth in low-birth-weight infants and support maternal mental health in low-income settings.
What could go wrong
This is a small, early-stage trial, and the benefit may be modest or not generalizable. The intervention's success depends on adherence and may not overcome other factors affecting infant growth.

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 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 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

0 days and older

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: * Newborn low birth weight (LBW) (birth weight \< 2500 grams) * Newborn birth weight \>= 1800 g * Newborn admitted to Neonatal Intensive Care Unit (NICU) * Newborn in stable condition without WHO danger signs * Newborn age \<24 hours old * Breastfeeding initiated * Residence in the catchment area Exclusion Criteria: * Twins and other multiples * Newborn respiratory support or WHO danger signs * Newborn with major congenital anomaly or expected surgery * Contraindications to or unable to breastfeed * Mother with hearing impairment * Unable to speak Luganda

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Conditions

The condition(s) this trial relates to.

Breast Feeding Malnutrition nutritional deficiency disease Psychological Well-Being

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

  • Makerere University School of Public Health

    Kampala, Uganda

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