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Skin-to-Skin care at home: new study aims to support rural indian mothers

NCT ID NCT07231432

Knowledge-focused Sponsor: University of Massachusetts, Worcester 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at ways to help mothers of preterm or low birth weight infants in rural India continue Kangaroo Care (skin-to-skin contact) at home after leaving the hospital. Researchers will work with 190 mothers and healthcare providers to understand what support is needed. The goal is to develop practical methods that make it easier for mothers to provide this beneficial care in their home environment.

What this could mean

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

What this could lead to
If successful, this could lead to better support programs that help mothers provide skin-to-skin care for their low birth weight babies at home, potentially improving infant health outcomes.
What could go wrong
This is an early-stage behavioral study with no active intervention yet, so results may not lead to immediate changes. The small sample size and focus on one region may limit how widely the findings apply.

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 190 people

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

Started

Jun 2025

Expected to finish

Dec 2028

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

18 years and older

Sex

Female participants only

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.

AIM 1 Mothers * Mothers of former low birthweight (\<2500 grams at birth) infants who were hospitalized in the Shree Krishna Hospital NICU * Performed Kangaroo Care during their infant's hospitalization * Live in a village that is "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital * At least 18 years old * Speak Gujarati Healthcare Providers- Physicians: * Physicians and nurses who work in either the Shree Krishna Hospital NICU or in community settings within a 50-kilometer radius who provide newborn care to at least 3 newborns each week * At least 18 years old * Speak Gujarati Village Health Workers: * Village health workers who operate in one of the "adopted" villages within a 50-kilometer radius of Shree Krishna Hospital * We will aim to recruit one health worker from 10 of the 15 subregions of the district of Anand, based on geography * At least 18 years old * Speak Gujarati AIM 2 Mothers: * Mothers of an infant born with low birthweight (\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g * Must reside in a village "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge * Speaks Gujarati * At least 18 years old AIM 3 Mothers: * Mothers of an infant born with low birthweight (\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g * Must reside in a village "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge * Speaks Gujarati * At least 18 years old Exclusion Criteria (applicable to all aims) * Persons unable to provide informed consent * Pregnant women may enroll in this study, though, we will not be intentionally recruiting pregnant women. (Refer to section 18 for more information on this) * Prisoners will not be included in the study

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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.

Kangaroo care Low birth weight Preterm birth Skin to skin contact

Contacts and locations

Locations

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655, United States

More trials for these conditions

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