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Dad's chest vs. incubator: new trial tests skin-to-skin transfer for tiniest babies

NCT ID NCT05820386

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether carrying a very preterm baby skin-to-skin on the father's chest from the delivery room to the neonatal intensive care unit (NICU) keeps the baby just as warm as the standard incubator transfer. About 118 babies born before 34 weeks will take part. The main goal is to see if skin-to-skin contact prevents heat loss as well as an incubator does.

What this could mean

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

Active substance
skin-to-skin contact (procedure)
What this could lead to
If it works, this could show that skin-to-skin transfer is a safe and effective alternative to incubator transfer for very preterm infants, potentially improving bonding and outcomes.
What could go wrong
This is a small, early-stage trial (118 infants) focused on temperature stability, not long-term outcomes. The procedure may not keep babies warm enough, and results may not apply to all preterm infants.

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 118 people

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

Started

May 2023

Expected to finish

Jun 2026

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

24 to 34 weeks

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: * Gestational age \< 34 weeks * Singleton pregnancy * Inborn birth, i.e., in the maternity ward of investigating centres * Need of hospitalization in the neonatal intensive care unit * Oral and written information of parents and written parental consent to participate in the study (by the father if the mother is unable to participate) Exclusion Criteria: * Single parent or homosexual couple * Absence of the father in the delivery room * Parents not speaking French * Skin temperature of the newborn \< 36°C at the time of randomization * Conditions not allowing the early skin-to-skin contact: omphalocele, gastroschisis, desquamating dermatological conditions (Harlequin syndrome, Collodion) * Clinical condition requiring a specific transfer mode according to the pediatrician in the delivery room * Parents under legal protection * Minor parents

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As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU Angers

    Angers, 49000, France

  • Neonatal and paediatric service, University Hospital, Tours

    Tours, 37000, France

  • Neonatal medicine and intensive care unit, University Hospital, Orléans

    Orléans, 45000, France

  • Neonatology service, University Hospital, Toulouse

    Toulouse, 31300, France

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