An observational study in Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded and Extubation Failure, sponsored by Centre Hospitalier Intercommunal Creteil. Not yet recruiting. Open to participants aged 0 Days to 3 Months. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Centre Hospitalier Intercommunal Creteil · Observational
The objective of this study is to evaluate the role of diaphragmatic electrical activity monitoring (collected by esophageal probe) around extubation of preterm patients in order to consider its use as a standardized objective criterion to aid in the decision to extubate.
All parents of newborns meeting the inclusion criteria and without exclusion criteria will be approached for the study. If the parents do not object, the investigators will include patients once a collegial decision to extubate has been made after re-verification of the inclusion/exclusion criteria.
After patient inclusion, patient data collection by Servo-tracker will be set up, and ancillary data (treatments, Neo Comfort scale, respiratory rate, transcutaneous capnography, ventilation parameters, tidal volume) will be recorded at a given time every hour until the patient is extubated.
At the same time, the investigators will extract medical and administrative data from the patients' electronic records into a database that can only be accessed on a department computer, protected by a password.
After extubation, the patient is monitored for 7 days to assess the need for reintubation and collect data if the patient is reintubated. At the end of the 7 days or after reintubation, the patient's study follow-up is complete.
They may be included again if they are extubated again during the study period.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 20 is below the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to the neonatal intensive care unit at the Creteil Intercommunal Hospital Center
Exclusion Criteria:
* All newborns born at \<32 weeks of amenorrhea hospitalized in the neonatal intensive care unit at CHIC * Patient intubated and ventialted with an Edi tube in place * Patient eligible for scheduled extubation
Extubation success
Comparaison with patients who experience extubation failure. Focusing on clinical, therapeutic, and ventilatory data. In particular data extracted by the servo-tracker software (collected from the time the software is installed on the ventilator following the decision to extubate until the actual extubation): * Maximum, minimum, and average EDI over the period * Tidal volume: maximum, minimum, and average over the period * Inspiratory time: maximum, minimum, and average over the period * Total time between the decision to extubate and the actual extubation This data will be used to calculate: * Neuro-mechanical efficiency: Mean tidal volume / Mean EDI max * Variability of the EDI max signal: its standard deviation * Respiratory variability: standard deviation of tidal volume
Time frame: 7 days
Time to reintubation
Duration between extubation and reintubation
Time frame: 7 days
Reintubation rate
Ratio of the number of patients who were reintubated to the total population
Time frame: 7 days
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The DPI will not be disclosed and will be retained for only two years after the results are published
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Intercommunal Creteil