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Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing

A Descriptive Prospective Study of Diaphragmatic Activity in Intubated Neonates Around Extubation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07709988
Acronym
NEODIALECT
Enrollment
20
Registered
2026-07-17
Start date
2026-07-01
Completion date
2027-01-30
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electric Diaphragmatic Activity (EAdi), Extubation Failure, Extubation Succeeded, Neonatal Intensive Care Unit (NICU), Preterm, Study of Predictors of Successful Extubation in Preterm Infants

Keywords

Extubation success, Preterm, extubation failure, observational study, Electric diaphragmatic activity (EAdi), neonatal intensive care unit (NICU)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 3 Months
Healthy volunteers
No

Inclusion 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

Exclusion criteria

* Absence of Edi tube * Palliative care situation * Patient treated with curare * Patients with neuromuscular disorders * Accidental extubation * Parental refusal

Design outcomes

Primary

MeasureTime frameDescription
Extubation success7 daysComparaison 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

Secondary

MeasureTime frameDescription
Time to reintubation7 daysDuration between extubation and reintubation
Reintubation rate7 daysRatio of the number of patients who were reintubated to the total population

Contacts

CONTACTEmeric EG Genet, Medical Doctor
emeric.genet@chicreteil.fr+33652555454
CONTACTXavier XD Durrmeyer, MD, Phd
durrmeyer.xavier@chicreteil.fr0157028470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026