Criteria and Reasons for Extubation and Non-extubation in Preterm Infants: A Mixed Methods Study Prospectively Exploring Extubation and Reintubation Practices in Extremely Preterm Infants, and Associated Respiratory Outcomes.

Status: Recruiting
Location: See all (30) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 5 months
Healthy Volunteers: f
View:

• Gestational age \< 28 weeks of gestation

• Age at admission to the participating unit \<24 hours

Locations
Other Locations
France
CHU Amiens Sud
NOT_YET_RECRUITING
Amiens
CH Cote Basque
COMPLETED
Bayonne
CHU De Besancon
RECRUITING
Besançon
Hopital Femme Mére Enfant - HFME
RECRUITING
Bron
Centre Hospitalier Public du Cotentin
RECRUITING
Cherbourg-octeville
CH Estaing
COMPLETED
Clermont-ferrand
Chu Louis Mourier
NOT_YET_RECRUITING
Colombes
CHIC
COMPLETED
Créteil
CHU Grenoble Alpes _site nord
COMPLETED
Grenoble
CHU Félix Guyon
COMPLETED
La Réunion
CHU Kremlin-Bicêtre
NOT_YET_RECRUITING
Le Kremlin-bicêtre
CH Le Mans
RECRUITING
Le Mans
CHU Lille
COMPLETED
Lille
HME Limoges
RECRUITING
Limoges
APHM_ Hôpital Nord
RECRUITING
Marseille
GHEF- Site de MEAUX
COMPLETED
Meaux
Chi Andre Gregoire
NOT_YET_RECRUITING
Montreuil
GHRMSA-Hopital Emile Muller
COMPLETED
Mulhouse
CHU NICE
NOT_YET_RECRUITING
Nice
Chu Nimes
COMPLETED
Nîmes
CH Orléans
COMPLETED
Orléans
CHU Necker
NOT_YET_RECRUITING
Paris
Chu Port Royal
NOT_YET_RECRUITING
Paris
CHU Robert Debre
COMPLETED
Paris
CHI Poissy - St Germain en LayE
NOT_YET_RECRUITING
Poissy
CHU Reims
COMPLETED
Reims
CHU Rennes
COMPLETED
Rennes
CH General Delafontaine
COMPLETED
Saint-denis
CH GHPSO
NOT_YET_RECRUITING
Senlis
CH Troyes
NOT_YET_RECRUITING
Troyes
Contact Information
Primary
Laurence Caeymaex, M.D, Ph.D
laurence.caeymaex@gmail.com
0033664095607
Backup
Camille JUNG, MD PhD
camille.jung@chicreteil.fr
0033157022268
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 100
Treatments
Extremely Low Gestational Age Newborns (elgans)
No intervention. unique group.
Sponsors
Leads: Centre Hospitalier Intercommunal Creteil

This content was sourced from clinicaltrials.gov