Skin-to-Skin cuddles may shield preemie brains from bleeding
NCT ID NCT07473882
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether kangaroo care (skin-to-skin contact with a parent) can reduce the risk of severe brain bleeding in extremely preterm newborns. About 314 babies born at 28 weeks or earlier will be randomly placed in a side-lying kangaroo position, a prone kangaroo position, or standard incubator care. The main goal is to see if the side-lying position lowers the chance of severe intraventricular hemorrhage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- kangaroo care (skin-to-skin contact) in side-lying or prone position
- What this could lead to
- If it works, this could point toward a simple, low-cost way to protect extremely premature babies from severe brain bleeding.
- What could go wrong
- This trial hasn't started yet and is relatively small (314 babies). The results may not apply to all preterm infants, and kangaroo care must be done carefully to avoid other risks.
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
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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
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About 314 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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1 minute to 72 hours
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Preterm infants born at 28 weeks of gestational age or less, admitted to the NICU and born at the study center (inborn), less than 72 hours old, with a parent or legal guardian present who is willing to provide kangaroo care. Exclusion Criteria: * Preterm infants in the immediate postoperative period following major surgery. * Preterm infants with congenital abdominal wall malformations. * Preterm infants requiring immobilization. * Preterm infants who are clinically unstable and unable to tolerate kangaroo care. * Preterm infants whose parents decline participation in the study.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hospital Universitario 12 de Octubre
Madrid, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can early feeding shape a premature Baby's brain and body?
- Talking therapy for NICU parents may boost premature babies' futures
- Storytime in the NICU: can reading to preemies boost bonding?
- Cuddle or feed before the prick: simple comforts may ease newborn pain
- Cuddle cure: kangaroo care boosts breastfeeding in First-Time moms?
- Can early therapy boost development in preterm babies?