Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
NCT ID: NCT06808997
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
100 participants
OBSERVATIONAL
2025-02-17
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Extubation Readiness Study in Very Low Birthweight Infants
NCT01471431
Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior
NCT01909947
Post-extubation Pressures in Preterm Neonates: A CER Study
NCT06552455
Ultrasound for Assessment of Extubation Readiness
NCT04957264
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
NCT01440647
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Early extubation is therefore recommended. However, extubation failures in patients born at these early stages of life are common and are per se associated with respiratory morbidity. Extubation failure is defined in the literature as reintubation within days of extubation.
A delay of 7 days after extubation has been identified as the time frame for capturing extubations related to respiratory causes. In a French study, using the SEPREVEN cohort for patients born before 27 weeks' GA, extubation failure at 3, 7 and 15 days concerned 25%, 33% and 50% of patients respectively. The decision to extubate a premature patient is a complex one, but contributes in part to the patient's outcome.
Shalish referred to the concept of "extubation readiness dilemma" to indicate the uncertainty surrounding the clinical features associated with successful extubation. Identifying a state for each patient that allows successful extubation, without reintubation in the following days, is most often based on ward routines in which assessments of the infant's respiratory capacity are taken into account. Medical literature doesn't provide recommendations on extubation criteria, and practices differ from one unit to another.
The aim of this study is to provide a detailed description of extubation practices and failures in several NICUs in France, based on a prospective collection of qualitative and mixed data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Extremely Low Gestational Age Newborns (elgans)
No intervention. unique group.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age at admission to the participating unit \<24 hours
Exclusion Criteria
* Participation in a research protocol with potential impact on extubation and/or duration of mechanical ventilation
1 Minute
5 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dr Jean-michel Roue
Brest, Brest, France
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Shalish W, Keszler M, Davis PG, Sant'Anna GM. Decision to extubate extremely preterm infants: art, science or gamble? Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):105-112. doi: 10.1136/archdischild-2020-321282. Epub 2021 Feb 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CERAINE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.