New study tests safer sedation for tiny lungs

NCT ID NCT04016246

Completed Disease control Sponsor: University Hospital, Grenoble Source: ClinicalTrials.gov ↗

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for RESPIRATORY DISTRESS SYNDROME IN PREMATURE INFANT are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.