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Can cuddling save tiny babies? trial tests early kangaroo care

NCT ID NCT03555981

Disease control Sponsor: London School of Hygiene and Tropical Medicine 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at whether starting continuous skin-to-skin contact (kangaroo mother care) within 24 hours of birth helps unstable preterm babies under 2000g survive. It compared this to standard incubator care. The trial took place in The Gambia and enrolled 279 babies, but was stopped early.

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 (continuous skin-to-skin contact)
What this could lead to
If successful, this could show that early skin-to-skin contact improves survival in unstable preterm babies in low-resource settings.
What could go wrong
The trial was terminated, so results are limited. It was a small study in one country, so findings may not apply elsewhere.

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

279 people

The number who actually took part.

Started

May 2018

Finished

Apr 2020

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 hour to 24 hours

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: * New admission to study site during study period * Admission weight \<2000g * Age 1 - 24h at start of screening * Alive at enrolment * Availability of study bed * Written informed consent from parent or caregiver * Parent or caregiver available and willing to provide intervention, if necessary Exclusion Criteria: * Congenital malformation incompatible with life or needing immediate surgical correction * Severe jaundice needing immediate management * Seizures * Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring * Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring * Completed triplet admission * Mother and/or neonate enrolled in another research study at time of hospital admission

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease Death Hypothermia Premature Birth

As listed by the trial registrant

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

Death Hypothermia, newborn Infection, bacterial Kangaroo mother care Preterm infant

Contacts and locations

Locations

  • MRC Unit The Gambia at LSHTM

    Fajara, West Coast, The Gambia

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