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NCT Number: NCT07709988

Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Extubation success

    Time frame: 7 days

    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

Secondary outcomes

  1. Time to reintubation

    Time frame: 7 days

    Duration between extubation and reintubation

  2. Reintubation rate

    Time frame: 7 days

    Ratio of the number of patients who were reintubated to the total population

Study contacts

Contact information is provided by the study sponsor or research team.

Emeric EG Genet, Medical Doctor

CONTACT

[email protected]

+33652555454

Xavier XD Durrmeyer, MD, Phd

CONTACT

[email protected]

0157028470

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: NEODIALECT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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