Actively Recruiting

Age: 1Minute - 5Months
All Genders
ID06808997

Criteria and Reasons for Extubation and Non-extubation in Preterm Infants: Exploring 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

16 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how neonatologists decide when extremely preterm infants, born before 28 weeks of gestational age, are ready to be taken off mechanical ventilation during the first two weeks of life. It focuses on the link between clinical assessments of extubation readiness and actual success, defined as no need for reintubation within seven days. The study also seeks to identify factors influencing these decisions and outcomes using both qualitative and quantitative data from several NICUs in France. The study involves no interventions or treatments but collects prospective information from attending physicians through questionnaires completed daily for the first 15 days of life while the infants are mechanically ventilated. Researchers will record reasons for extubation or non-extubation and monitor respiratory outcomes, including extubation failure rates and the duration of various types of respiratory support up to four months of age. Mortality and complications related to intubation will also be documented. Participants will be closely observed throughout their NICU stay, with data collected on respiratory status, mechanical ventilation duration, and clinical decisions regarding extubation. The primary outcome is the reasons for not extubating during the first 15 days of life, assessed multiple times daily early on and daily thereafter. Secondary outcomes include extubation readiness perceptions, extubation failure, bronchopulmonary dysplasia occurrence, length of NICU stay, and mortality up to five months of age. The study will conclude when patients are discharged or definitively weaned off respiratory support.

CONDITIONS

Brief 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
  • Admitted to the participating unit within 24 hours of birth
Not Eligible

You will not qualify if you...

  • Parental opposition to clinical data collection
  • Participating in another research study that might affect extubation or mechanical ventilation duration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 24 hours after birth

Participants are screened for eligibility to participate in the trial.

1 visit (in-person, within 24 hours of birth)

Monitoring

Duration - From birth up to 4 months of age or until discharge from the NICU/hospital

Participants who are mechanically ventilated are observed to record extubation practices, respiratory support duration, and related outcomes.

Daily assessments from Day 0 to Day 15 during mechanical ventilation and ongoing monitoring until discharge

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

C

Camille JUNG, MD PhD

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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