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New study tests safer sedation for tiny lungs

NCT ID NCT04016246

Disease control Sponsor: University Hospital, Grenoble 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving a sedative called propofol to very premature babies (under 32 weeks) before a less invasive breathing treatment (LISA) is safe and reduces the need for a breathing machine. The trial involved 233 infants with breathing problems. Researchers compared propofol to a placebo, with rescue pain medicine available if needed.

What this could mean

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

Active substance
propofol
What this could lead to
If it works, this could provide a safer way to give sedation to premature babies during a breathing treatment, potentially reducing the need for a breathing tube.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all premature infants. Propofol can cause side effects like low blood pressure or breathing problems in newborns.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

233 people

The number who actually took part.

Started

Oct 2019

Finished

Apr 2026

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: * Preterm Infants \< 32 wGA (weeks of gestational age) * Presenting a RDS (respiratory distress syndrome) * in the first 48 hours of life * treated by CPAP (continuous positive airway pressure) or BiPAP (Bilevel Positive Airway Pressure) * requiring surfactant : * FIO2 : (fraction of inspired oxygen) * if 28 - 31 SA : FiO2 ≥30% for a duration ≥ 10mn * if \<28 SA FIO2 ≥25% for a duration ≥10mn * SpO2 (arterial oxygen saturation) : to obtain a SpO2 between ≥88 and ≤ 95% * Available IntraVenous line (peripheral, umbilical or central catheter) * Recipient of the French Social Security * Informed consent form signed Exclusion Criteria: * Congenital and/or major malformations * FIO2 \>60% * Silverman score \>6 * Contraindication to the use of Propofol : * Low Blood Pressure with 2 successive measurements (Mean \< Gestational Age expressed in Weeks of Gestation) persisting after one volume expansion, * Use of inotropic medication to maintain a normal blood pressure. * Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h * Coma, convulsions, areactivity at neurological examination

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Conditions

The condition(s) this trial relates to.

Premature Birth respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Respiratory distress syndrome in premature infant

Contacts and locations

Locations

  • Ap-H Marseille

    Marseille, 13000, France

  • CHU Grenoble Alpes

    Grenoble, Isère, 38043, France

  • Ch Rennes

    Rennes, 35000, France

  • Chi Creteil

    Créteil, 94000, France

  • Chi Poissy St Germain

    Poissy, 78300, France

  • Chu Amiens

    Amiens, 80000, France

  • Chu Angers

    Angers, 49000, France

  • Chu Brest

    Brest, 29200, France

  • Chu Chambery

    Chambéry, 73000, France

  • Chu Limoges

    Limoges, 87000, France

  • Chu Nantes

    Nantes, 44000, France

  • Chu Nimes

    Nîmes, 30000, France

  • centre hospitalier deTroyes

    Troyes, Aube, 10000, France

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