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Skin-to-Skin time may shield new moms from depression

NCT ID NCT06545760

Knowledge-focused Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests whether spending more than 2 days in a kangaroo mother care (KMC) ward—where mothers hold their low birthweight babies skin-to-skin and get breastfeeding support—can lower the risk of postpartum depression. About 1,900 mothers and their preterm infants in Zambia will be randomly assigned to either extended KMC or standard short KMC. Researchers will track depression scores and infant development over 18 months.

What this could mean

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

Active substance
kangaroo mother care (KMC) support
What this could lead to
If successful, this could show that extended KMC helps prevent postpartum depression and improves infant development, offering a low-cost intervention for low-resource settings.
What could go wrong
This is an early-stage trial with no prior results, and outcomes depend on adherence and follow-up in a challenging setting. The intervention is behavioral, so effects may vary widely.

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 1,908 people

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

Started

Dec 2024

Expected to finish

Sep 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 89 years

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: -AIM #1-2 and #5 Newborns who are: 1. Birthweight between 1000-2000gm 2. Admitted to the Women and Newborn Hospital-University Teaching Hospital (WNH-UTH) Neonatal Intensive Care Unit (NICU) \>48hrs ago 3. Stable preterm eligible for receiving KMC at the KMC Ward And their mothers who are - 4\. 16+ years of age (Mother) 5\. Residing within Lusaka Province with no intensions to relocate in the coming 18 months * AIM #3 1. Parents (mothers and fathers) whose newborn has been enrolled in the study 2. Trusted family member or friend of the mother whose newborns is enrolled into the study 3. 16+ years of age (mothers and fathers) 4. 18+ years of age (family members) * AIM # 4: 1. Fathers whose newborn has been enrolled into the study 2. 16+ years of age Exclusion Criteria: * AIM #1-2 and #5 1. Mothers who are on treatment for depression and/or anxiety 2. Mothers who did not consent 3. Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study * AIM #3 1\) Family members of parents who do not consent to study participation * AIM # 4: 1. Fathers who are on treatment for depression and/or anxiety 2. Fathers who did not provide informed consent 3. Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study

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Conditions

The condition(s) this trial relates to.

postpartum depression Premature Birth

As listed by the trial registrant

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

Kangaroo mother care Low birth weight Neurodevelopmental outcome Postpartum depression Pre-term

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Women and Newborn Hospital - University Teaching Hospitals

    RECRUITING

    Lusaka, 10101, Zambia

More trials for these conditions

Other studies related to the condition(s) this trial covers.