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RECRUITING
NCT06808997

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

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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.

Official title: Criteria and Reasons for Extubation and Non-extubation in Preterm Infants: A Mixed Methods Study Prospectively Exploring Extubation and Reintubation Practices in Extremely Preterm Infants, and Associated Respiratory Outcomes.

Key Details

Gender

All

Age Range

1 Minute - 5 Months

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-02-17

Completion Date

2026-04-30

Last Updated

2026-03-12

Healthy Volunteers

No

Locations (31)

CHU Amiens Sud

Amiens, France

CH Cote Basque

Bayonne, France

CHU De Besancon

Besançon, France

Dr Jean-michel Roue

Brest, France

Hopital Femme Mére Enfant - HFME

Bron, France

Centre Hospitalier Public du Cotentin

Cherbourg-Octeville, France

CH Estaing

Clermont-Ferrand, France

Chu Louis Mourier

Colombes, France

CHIC

Créteil, France

CHU Grenoble Alpes _site nord

Grenoble, France

CHU Félix Guyon

La Réunion, France

CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, France

CH Le Mans

Le Mans, France

CHU Lille

Lille, France

HME Limoges

Limoges, France

APHM_ Hôpital Nord

Marseille, France

GHEF- Site de MEAUX

Meaux, France

Chi Andre Gregoire

Montreuil, France

GHRMSA-Hopital Emile Muller

Mulhouse, France

CHU NICE

Nice, France

Chu Nimes

Nîmes, France

CH Orléans

Orléans, France

CHU Robert Debre

Paris, France

Chu Port Royal

Paris, France

CHU Necker

Paris, France

CHI Poissy - St Germain en LayE

Poissy, France

CHU Reims

Reims, France

CHU Rennes

Rennes, France

CH General Delafontaine

Saint-Denis, France

CH GHPSO

Senlis, France

CH Troyes

Troyes, France