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Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
Sponsor: Centre Hospitalier Intercommunal Creteil
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
Conditions
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