Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
Recruiting now
Conditions studied: PreTerm Neonate, Extubation Readiness, Extubation Failure, Respiratory Morbidity, Bronchopulmonary Dysplasia, Mechanical Ventilation
In brief
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.
Key facts
- Study ID
- NCT06808997
- Run by
- Centre Hospitalier Intercommunal Creteil
- People needed
- 100
- Starts
- 2025-02-17
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2026-03-12
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gestational age < 28 weeks of gestation
- Age at admission to the participating unit <24 hours
You may not qualify if…
- Parental opposition to their infant's clinical data collection
- Participation in a research protocol with potential impact on extubation and/or duration of mechanical ventilation
Where it is running
- Dr Jean-michel Roue — Brest, France (enrolling)
- CHU Amiens Sud — Amiens, France
- CH Cote Basque — Bayonne, France
- CHU De Besancon — Besançon, 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
Full record on ClinicalTrials.gov
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