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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients of neonatal intensive care unit |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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):
This data will be used to calculate:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reintubation | Duration between extubation and reintubation | 7 days |
| Reintubation rate | Ratio of the number of patients who were reintubated to the total population |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the neonatal intensive care unit at the Creteil Intercommunal Hospital Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emeric EG Genet, Medical Doctor | Contact | +33652555454 | emeric.genet@chicreteil.fr | |
| Xavier XD Durrmeyer, MD, Phd | Contact | 0157028470 | durrmeyer.xavier@chicreteil.fr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39289731 | Background | Parrilla-Gomez FJ, Roche-Campo F, Italiano S, Parrilla-Gomez A, Moran I, Mancebo J, Maraffi T. Time course of electrical activity of the diaphragm (EAdi) in the peri extubation period and its role as predictor of extubation failure in difficult to wean patients. Crit Care. 2024 Sep 17;28(1):308. doi: 10.1186/s13054-024-05092-x. | |
| 37660179 |
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The DPI will not be disclosed and will be retained for only two years after the results are published
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2026 | Jun 16, 2026 |
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| 7 days |
| Scholten AWJ, van Leuteren RW, de Waal CG, Kraaijenga JV, de Jongh FH, van Kaam AH, Hutten GJ. Diaphragmatic electromyography in infants: an overview of possible clinical applications. Pediatr Res. 2024 Jan;95(1):52-58. doi: 10.1038/s41390-023-02800-1. Epub 2023 Sep 2. |
| 19380428 | Background | Hermeto F, Bottino MN, Vaillancourt K, Sant'Anna GM. Implementation of a respiratory therapist-driven protocol for neonatal ventilation: impact on the premature population. Pediatrics. 2009 May;123(5):e907-16. doi: 10.1542/peds.2008-1647. Epub 2009 Apr 20. |
| 39118595 | Background | Khodak I, Kahovec M, Romano V, Nielsen A, Day CL, Dylag AM. Reducing Failed Extubations in Preterm Infants Via Standardization and Real-Time Decision Support. Pediatrics. 2024 Sep 1;154(3):e2023062930. doi: 10.1542/peds.2023-062930. |
| 38553331 | Background | Sant'Anna G, Shalish W. Weaning from mechanical ventilation and assessment of extubation readiness. Semin Perinatol. 2024 Mar;48(2):151890. doi: 10.1016/j.semperi.2024.151890. Epub 2024 Mar 23. |
| 33627331 | Background | Shalish W, Keszler M, Davis PG, Sant'Anna GM. Decision to extubate extremely preterm infants: art, science or gamble? Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):105-112. doi: 10.1136/archdischild-2020-321282. Epub 2021 Feb 24. |
| 30404739 | Background | Shalish W, Kanbar L, Kovacs L, Chawla S, Keszler M, Rao S, Panaitescu B, Laliberte A, Precup D, Brown K, Kearney RE, Sant'Anna GM. The Impact of Time Interval between Extubation and Reintubation on Death or Bronchopulmonary Dysplasia in Extremely Preterm Infants. J Pediatr. 2019 Feb;205:70-76.e2. doi: 10.1016/j.jpeds.2018.09.062. Epub 2018 Nov 5. |
| 39814054 | Background | Hoff Calegari L, Goyal M, Dutta S, Mukerji A. Predictors and Outcomes of Extubation Failure in Preterm Neonates: A Systematic Review. Pediatrics. 2025 Feb 1;155(2):e2024068677. doi: 10.1542/peds.2024-068677. |
| 29198532 | Background | Choi YB, Lee J, Park J, Jun YH. Impact of Prolonged Mechanical Ventilation in Very Low Birth Weight Infants: Results From a National Cohort Study. J Pediatr. 2018 Mar;194:34-39.e3. doi: 10.1016/j.jpeds.2017.10.042. Epub 2017 Dec 1. |
| 35040888 | Background | Bell EF, Hintz SR, Hansen NI, Bann CM, Wyckoff MH, DeMauro SB, Walsh MC, Vohr BR, Stoll BJ, Carlo WA, Van Meurs KP, Rysavy MA, Patel RM, Merhar SL, Sanchez PJ, Laptook AR, Hibbs AM, Cotten CM, D'Angio CT, Winter S, Fuller J, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Mortality, In-Hospital Morbidity, Care Practices, and 2-Year Outcomes for Extremely Preterm Infants in the US, 2013-2018. JAMA. 2022 Jan 18;327(3):248-263. doi: 10.1001/jama.2021.23580. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2025 | Jun 16, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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