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Could early kangaroo care save more tiny newborns?

NCT ID NCT02811432

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether starting kangaroo mother care (skin-to-skin contact) early, before babies are stable, reduces death within 7 days compared to standard incubator care. Over 2,200 low birth weight infants (700-2000g) at four Ugandan hospitals took part. The goal was to see if early skin-to-skin care could lower mortality by 25%.

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 (skin-to-skin contact)
What this could lead to
If successful, this could show that starting skin-to-skin care early saves more lives in low birth weight babies, especially in resource-limited settings.
What could go wrong
This is a completed trial, but results may not apply to all hospitals or settings. The intervention requires caregiver commitment, and benefits may vary by infant condition.

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

2,221 people

The number who actually took part.

Started

Oct 2019

Finished

Sep 2022

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 48 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 * Liveborn at Jinja Hospital, Masaka Hospital, Entebbe Hospital, or Iganga Hospital * Singleton or twin pregnancy * Birthweight ≥700g and ≤2000g * Chronological age 1-48 hours at time of screening * Alive at time of recruitment * Parent/caregiver able and willing to provide KMC * Parent/caregiver willing to attend follow-up visit * Indication for KMC "uncertain" according to WHO guideline concerning clinical stability: pragmatically defined as receiving ≥1 therapy: oxygen, CPAP, IV fluids, therapeutic antibiotics, phenobarbital Exclusion criteria * Outborn * Result of triplet or higher order multifetal pregnancy * Indication for KMC "certain" according to WHO guidelines: pragmatically defined as clinically well neonates receiving none of the above therapy-based criteria * Severely life-threatening instability defined as SpO2 \<88% in oxygen AND ≥1 of: * Respiratory rate \<20 or \>100 breaths/min * Apnoea requiring bag-mask ventilation * HR \<100 or \>200 bpm * Severe jaundice requiring immediate management * Active neonatal seizures * Major congenital malformation * Parent does not provide written informed consent to participate in trial * Mother or neonate enrolled in another MRC/UVRI research project

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Conditions

The condition(s) this trial relates to.

Hypothermia Perinatal Death Premature Birth

As listed by the trial registrant

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

Death; neonatal Hypothermia, newborn Kangaroo mother care Preterm infant

Contacts and locations

Locations

  • Entebbe

    Entebbe, Uganda

  • Iganga District Hospital

    Iganga, Uganda

  • Jinja Regional Referral Hospital

    Jinja, Uganda

  • Masaka Regional Referral Hospital

    Masaka, Uganda

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