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Could a simple blanket prevent dangerous heat loss in newborns?

NCT ID NCT06275932

Disease control Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 compares two ways to keep healthy full-term newborns warm during skin-to-skin contact with their mothers right after birth. One group uses a thermal blanket, while the other uses standard bedding (a mat and cotton sheet). The goal is to see which method better prevents hypothermia, which can lead to serious health problems. The trial involves newborns born vaginally at 37 weeks or later.

What this could mean

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

Active substance
thermal blanket
What this could lead to
If effective, using a simple thermal blanket could become a low-cost way to prevent hypothermia in healthy newborns right after birth.
What could go wrong
This is a small, early-stage trial with no blinding, so results may not be conclusive or widely applicable. The intervention is low-risk but may not significantly improve temperature control.

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.

Started

Apr 2025

Expected to finish

Apr 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: For mother * Mothers' age over 18 years and good comprehension of Italian language; * Signed informed consent of the mother. For newborn * Informed consent signed by both parents, or in the case of a single-parent family, by mother * Gestational age at birth greater than or equal to 37+0 weeks * Newborns from singleton pregnancies; * Both male and female newborns; * Newborns who will be born from vaginal birth. Exclusion Criteria: For mother * Mothers who do not want to carry out skin-to-skin contact; * Mothers who do not understand/speak the Italian language; * Mothers who need assistance procedures that hinder skin-to-skin contact. For newborn * Newborns whose parents decline participation in the study; * Newborns with major congenital anomalies (heart, brain, metabolic, gastrointestinal); * Newborns born via cesarean section; * Newborns whose parents are under 18 years old, in the case of a single parent the mother who is under 18 years; * Newborns requiring neonatal resuscitation after birth with obstruction of the skin-to-skin contact.

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Conditions

The condition(s) this trial relates to.

Hypothermia

As listed by the trial registrant

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

Body temperature Delivery room Newborn infant

Contacts and locations

Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

More trials for these conditions

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