Actively Recruiting

Age: 1Minute - 5Months
All Genders
NCT06808997

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

Led by Centre Hospitalier Intercommunal Creteil · Updated on 2026-03-12

100

Participants Needed

31

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Minute - 5Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age less than 28 weeks
  • Admission to the participating unit within 24 hours of birth
Not Eligible

You will not qualify if you...

  • Parental refusal to allow collection of the infant's clinical data
  • Participation in a research study that might affect extubation or time on mechanical ventilation

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 31 locations

1

CHU Amiens Sud

Amiens, France, 80054

Completed

2

CH Cote Basque

Bayonne, France, 64109

Completed

3

CHU De Besancon

Besançon, France, 25030

Completed

4

Dr Jean-michel Roue

Brest, France, 26609

Actively Recruiting

5

Hopital Femme Mére Enfant - HFME

Bron, France, 69677

Completed

6

Centre Hospitalier Public du Cotentin

Cherbourg-Octeville, France, 50102

Completed

7

CH Estaing

Clermont-Ferrand, France, 63 003

Completed

8

Chu Louis Mourier

Colombes, France, 92700

Completed

9

CHIC

Créteil, France, 94000

Completed

10

CHU Grenoble Alpes _site nord

Grenoble, France, 38700

Completed

11

CHU Félix Guyon

La Réunion, France, 97405

Completed

12

CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, France, 94270

Completed

13

CH Le Mans

Le Mans, France, 72037

Completed

14

CHU Lille

Lille, France, 75019

Completed

15

HME Limoges

Limoges, France, 87042

Completed

16

APHM_ Hôpital Nord

Marseille, France, 13915

Completed

17

GHEF- Site de MEAUX

Meaux, France, 77104

Completed

18

Chi Andre Gregoire

Montreuil, France, 93105

Completed

19

GHRMSA-Hopital Emile Muller

Mulhouse, France, 68100

Completed

20

CHU NICE

Nice, France, 06202

Completed

21

Chu Nimes

Nîmes, France, 30000

Completed

22

CH Orléans

Orléans, France, 45067

Completed

23

CHU Robert Debre

Paris, France, 75019

Completed

24

Chu Port Royal

Paris, France, 75679

Completed

25

CHU Necker

Paris, France, 75743

Completed

26

CHI Poissy - St Germain en LayE

Poissy, France, 78303

Completed

27

CHU Reims

Reims, France, 51100

Completed

28

CHU Rennes

Rennes, France, 35203

Completed

29

CH General Delafontaine

Saint-Denis, France, 93205

Completed

30

CH GHPSO

Senlis, France, 60300

Completed

31

CH Troyes

Troyes, France, 10000

Completed

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Research Team

L

Laurence Caeymaex, M.D, Ph.D

CONTACT

C

Camille JUNG, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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