Dietary Pattern Intervention for Neurodevelopment in Preterm Infants
NCT07702734
Dysbiosis, Female Urogenital Diseases and Pregnancy Complications
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT Number: NCT07709988
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.
Trial opening soon.
Get Notified0 day–3 month
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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):
This data will be used to calculate:
Time frame: 7 days
Duration between extubation and reintubation
Time frame: 7 days
Ratio of the number of patients who were reintubated to the total population
Contact information is provided by the study sponsor or research team.
Emeric EG Genet, Medical Doctor
CONTACT
Xavier XD Durrmeyer, MD, Phd
CONTACT
Centre Hospitalier Intercommunal Creteil
Other
A Descriptive Prospective Study of Diaphragmatic Activity in Intubated Neonates Around Extubation
Acronym: NEODIALECT
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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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