Decision to extubate extremely preterm infants: art, science or gamble?
Wissam Shalish, Martin Keszler, Peter G Davis...
https://pubmed.ncbi.nlm.nih.gov/33627331Actively Recruiting
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2026-03-12
100
Participants Needed
31
Research Sites
16 weeks
Total Duration
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
Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
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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)
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
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
L
Laurence Caeymaex, M.D, Ph.D
C
Camille JUNG, MD PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Wissam Shalish, Martin Keszler, Peter G Davis...
https://pubmed.ncbi.nlm.nih.gov/33627331