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Respiratory Effect of the LISA Method with Sedation by Propofol Versus Absence of Sedation.

NCT04016246 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2024-12-12

No results posted yet for this study

Summary

The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.

Conditions

  • Respiratory Distress Syndrome in Premature Infant

Interventions

DRUG

Propofol-Lipuro

sedation of babies \< 32wGA with propofol / placebo before a LISA Procedure

DRUG

Placebos

injected to babies \< 32wGA with propofol / placebo before a LISA Procedure

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Thierry DEBILLON, MD PHD · CHU de Grenoble Alpes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2024-03-18
Completion
2026-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016246 on ClinicalTrials.gov