Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.

Last updated: July 18, 2025
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Treatment

N/A

Clinical Study ID

NCT06808997
CERAINE
  • Ages 1-5
  • All Genders

Study Summary

The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective qualitative and quantitative data. Actual extubation readiness is defined as successful extubation, defined as no reintubation in the 7 days following extubation.

Key research questions are: How do clinicians assess extubation readiness in this population? Does this assessment correlate with actual extubation success? What factors (reasons, clinical status, ventilatory parameters) are associated with extubation readiness? Patients born before 28 weeks gestational age and admitted to the neonatal intensive care unit (NICU) within the first 24 hours are be included. The attending physician will complete a prospectively administered questionnaire with open-ended and multiple-choice questions to daily assess the decision and rationale for extubation or non-extubation of patients mechanically ventilated during the first 15 days of life.

Patient characteristics, respiratory outcomes, and mortality will be recorded until the end of hospitalisation and/or definitive weaning from any ventilatory support or supplemental oxygen.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gestational age < 28 weeks of gestation

  • Age at admission to the participating unit <24 hours

Exclusion

Exclusion Criteria:

  • Parental opposition to their infant's clinical data collection

  • Participation in a research protocol with potential impact on extubation and/orduration of mechanical ventilation

Study Design

Total Participants: 100
Study Start date:
February 20, 2025
Estimated Completion Date:
April 30, 2026

Study Description

With prolonged stays in the neonatal intensive care unit (NICU) and significant respiratory morbidity, respiratory management of the most premature newborns - born before 28 weeks gestational age (GA) - brings a number of challenges. Despite recommendations to give priority to non-invasive ventilation in cases of respiratory insufficiency, recent studies show that over 80% of these newborns receive mechanical ventilation (MV) at least once in their NICU course, most within the first week of life (100% if born at 23 SA, >90% at 24 and 25 SA, >80% at 26 and >70% at 27 weeks GA). Several studies have shown that a longer cumulative duration of MV is associated with a worse respiratory and neurodevelopmental prognosis in this population.

Early extubation is therefore recommended. However, extubation failures in patients born at these early stages of life are common and are per se associated with respiratory morbidity. Extubation failure is defined in the literature as reintubation within days of extubation.

A delay of 7 days after extubation has been identified as the time frame for capturing extubations related to respiratory causes. In a French study, using the SEPREVEN cohort for patients born before 27 weeks' GA, extubation failure at 3, 7 and 15 days concerned 25%, 33% and 50% of patients respectively. The decision to extubate a premature patient is a complex one, but contributes in part to the patient's outcome.

Shalish referred to the concept of "extubation readiness dilemma" to indicate the uncertainty surrounding the clinical features associated with successful extubation. Identifying a state for each patient that allows successful extubation, without reintubation in the following days, is most often based on ward routines in which assessments of the infant's respiratory capacity are taken into account. Medical literature doesn't provide recommendations on extubation criteria, and practices differ from one unit to another.

The aim of this study is to provide a detailed description of extubation practices and failures in several NICUs in France, based on a prospective collection of qualitative and mixed data.

Connect with a study center

  • CHU Amiens Sud

    Amiens, 80054
    France

    Site Not Available

  • CH Cote Basque

    Bayonne, 64109
    France

    Completed

  • CHU De Besancon

    Besancon, 25030
    France

    Active - Recruiting

  • Hopital Femme Mére Enfant - HFME

    Bron, 69677
    France

    Active - Recruiting

  • Centre Hospitalier Public du Cotentin

    Cherbourg-Octeville, 50102
    France

    Active - Recruiting

  • CH Estaing

    Clermont-Ferrand, 63 003
    France

    Completed

  • Chu Louis Mourier

    Colombes, 92700
    France

    Site Not Available

  • CHIC

    Creteil, 94000
    France

    Completed

  • CHU Grenoble Alpes _site nord

    Grenoble, 38700
    France

    Completed

  • CHU Félix Guyon

    La reunion, 97405
    France

    Completed

  • CHU Kremlin-Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • CH Le Mans

    Le Mans, 72037
    France

    Active - Recruiting

  • CHU Lille

    Lille, 75019
    France

    Completed

  • HME Limoges

    Limoges, 87042
    France

    Active - Recruiting

  • APHM_ Hôpital Nord

    Marseille, 13915
    France

    Active - Recruiting

  • GHEF- Site de MEAUX

    Meaux, 77104
    France

    Completed

  • Chi Andre Gregoire

    Montreuil, 93105
    France

    Site Not Available

  • GHRMSA-Hopital Emile Muller

    Mulhouse, 68100
    France

    Completed

  • CHU NICE

    Nice, 06202
    France

    Site Not Available

  • Chu Nimes

    Nimes, 30000
    France

    Completed

  • CH Orléans

    Orleans, 45067
    France

    Completed

  • CHU Necker

    Paris, 75743
    France

    Site Not Available

  • CHU Robert Debre

    Paris, 75019
    France

    Completed

  • Chu Port Royal

    Paris, 75679
    France

    Site Not Available

  • CHI Poissy - St Germain en LayE

    Poissy, 78303
    France

    Site Not Available

  • CHU Reims

    Reims, 51100
    France

    Completed

  • CHU Rennes

    Rennes, 35203
    France

    Completed

  • CH General Delafontaine

    Saint Denis, 93205
    France

    Completed

  • CH GHPSO

    Senlis, 60300
    France

    Site Not Available

  • CH Troyes

    Troyes, 10000
    France

    Site Not Available

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