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Could a safer anesthetic help premature babies born by C-Section?

NCT ID NCT02029898

Knowledge-focused Sponsor: University Hospital, Rouen 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether using remifentanil, a fast-acting opioid, during general anesthesia for emergency C-sections affects how well premature babies adapt after birth. Researchers compared two groups of mothers and their premature babies: one group received remifentanil, the other a placebo. The main goal was to check Apgar scores (a measure of newborn health) at 5 minutes after birth.

What this could mean

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

Active substance
remifentanil
What this could lead to
If successful, this could help doctors choose safer anesthesia for emergency C-sections in premature births, potentially improving newborn outcomes.
What could go wrong
This is an early-phase, single-center study with only 53 participants, so results may not apply broadly. The primary focus is safety, 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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

53 people

The number who actually took part.

Started

Feb 2014

Finished

Jun 2018

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

18 years and older

Sex

Female participants only

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: Inclusion criteria of the mother: * Patient over 18 years * Single pregnancy with an indication for cesarean section under general anesthesia context of prematurity (\<37SA) * Patient informed and written consent for participation in this research signed * Affiliation to social security Inclusion criteria of the child: Parents informed and written consent signed by the father and mother for the participation in this research by the child (unless a parent no longer has parental authority) Exclusion Criteria: Non-inclusion criteria of the mother: * Vaginal Delivery * Mother pathology requiring the use of an opioid during induction * Severe Preeclampsia * More than 14 weeks between the information and the inclusion * Patient under guardianship Non-inclusion criteria of the child: Fetal pathology diagnosed in the prenatal period involving the prognosis of the child

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As listed by the trial registrant

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

Anesthesia Cesarean section

Contacts and locations

Locations

  • CHU de Rouen

    Rouen, 76031, France

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