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New protocol aims to save more premature babies from severe complications

NCT ID NCT05248477

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new care protocol (EXPRIM) for extremely preterm infants born between 22 and 26 weeks. The protocol involves early counseling, standardized steroid use, and team-based decisions. Researchers will compare survival without severe health problems in 2377 babies across multiple hospitals. The goal is to see if this organized approach improves outcomes compared to usual care.

What this could mean

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

Active substance
new care protocol (EXPRIM protocol)
What this could lead to
If successful, this could establish a better standard of care for extremely preterm infants, reducing severe complications like brain bleeding or lung disease.
What could go wrong
This is a large trial but tests a complex organizational change, not a drug. Results depend on how well hospitals adopt the protocol, and benefits may vary across centers.

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

2,377 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 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

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: Mothers: * women hospitalized between 22 and 26 weeks for risk of preterm delivery with a fetus alive or dead at admission and with a delivery between 22 and 26 completed weeks * understanding of the French language by the woman or in the immediate entourage in charge of the child. Children: all newborns (live- and stillborn) delivered between 22 and 26 weeks. Exclusion Criteria * women who object to the use of their routine perinatal data, * women giving birth before 22 weeks and after 26 completed weeks. * woman to legal protection (subject protected by law under guardianship or curatorship) * Women undergoing a termination of pregnancy (TOP) for severe congenital anomaly or psycho-social contexte

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As listed by the trial registrant

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

Extreme prematurity Newborn Pretrm infants

Contacts and locations

Locations

  • Hôpital Cochin

    Paris, 75014, France

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