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Incubator settings may affect comfort of tiniest babies

NCT ID NCT03648606

Knowledge-focused Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at how different incubator settings affect the thermal comfort of very premature infants (born before 32 weeks). Researchers compare two regulation modes—standard 'Air' mode versus 'Cutaneous' (skin-based) mode—to see which reduces stress, measured by changes in heart and breathing rates. The study involves 29 infants over their first 10 days of life, using skin temperature measurements and sleep monitoring.

What this could mean

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

What this could lead to
If successful, this could improve thermal comfort and reduce stress for very premature infants in incubators.
What could go wrong
This is a small, early-stage study with only 29 infants, so results may not apply broadly. The intervention is a comparison of existing regulation modes, not a new treatment.

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.

Participants

29 people

The number who actually took part.

Started

Jun 2010

Finished

Jan 2017

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.

Who is studied

Premature infants less than 32 weeks of amenorrhea admitted to birth in the Neonatal Medicine Unit will be included after obtaining written parental consent. Data will be collected during the first 10 days of life of the preterm infant.

Ages

1 day to 10 days

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: * premature newborns 25 to 32 weeks of amenorrhea; * arrival in the Neonatal Medicine Unit \<12 hours of life; * need for management in a closed incubator; * availability of an incubator equipped with communication card. Exclusion Criteria: * premature newborns\> 32 weeks of amenorrhea; * arrival in the Neonatal Medicine unit after 12 hours of life; * presence of malformation syndrome or serious heart disease; * pathology requiring management within the first 10 days of life; * Apgar score \<5 at 10 minutes of life; * need for initial management in an open incubator; * unavailability of an incubator equipped with a communication card

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As listed by the trial registrant

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

Thermoregulation

Contacts and locations

Locations

  • CHU Amiens-Picardie

    Amiens, 80054, France

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