Study of Predictors of Successful Extubation in Preterm InfantsNEODIALECTNCT07709988
Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing
An observational study of Study of Predictors of Successful Extubation in Preterm Infants and Extubation Succeeded, run by Centre Hospitalier Intercommunal Creteil.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 3 months
- Conditions the study is for
- Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded, Extubation Failure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jan 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients admitted to the neonatal intensive care unit at the Creteil Intercommunal Hospital Center
Who may be able to join
- 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
Who cannot join
- Absence of Edi tube
- Palliative care situation
- Patient treated with curare
- Patients with neuromuscular disorders
- Accidental extubation
- Parental refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Descriptive Prospective Study of Diaphragmatic Activity in Intubated Neonates Around Extubation
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.
Read the 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.
- Conditions
- Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded, Extubation Failure, Preterm, Electric Diaphragmatic Activity (EAdi), Neonatal Intensive Care Unit (NICU)
- Keywords
- Extubation success, Preterm, extubation failure, observational study, Electric diaphragmatic activity (EAdi), neonatal intensive care unit (NICU)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients of neonatal intensive care unit | * 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (2)
Time to reintubation
Duration between extubation and reintubation
Measured: 7 days
Reintubation rate
Ratio of the number of patients who were reintubated to the total population
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion4 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Study of Predictors of Successful Extubation in Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Durrmeyer, MD, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709988
- Sponsor's protocol ID
- NEODIALECT
- Acronym
- NEODIALECT
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The DPI will not be disclosed and will be retained for only two years after the results are published
Publications
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.
PubMed 39289731Scholten 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.
PubMed 37660179Hermeto 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.
PubMed 19380428Khodak 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.
PubMed 39118595Sant'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.
PubMed 38553331Shalish 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.
PubMed 33627331Shalish 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.
PubMed 30404739Hoff 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.
PubMed 39814054Choi 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.
PubMed 29198532Bell 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.
PubMed 35040888
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Prospective Study of Diaphragmatic Activity in Intubated Neonates Around Extubation
- ClinicalTrials.gov ID
- NCT07709988
- Acronym / sponsor ID
- NEODIALECT / NEODIALECT
- Conditions
- Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded, Extubation Failure, Preterm, Electric Diaphragmatic Activity (EAdi), Neonatal Intensive Care Unit (NICU)
- Keywords
- Extubation success, Preterm, extubation failure, observational study, Electric diaphragmatic activity (EAdi), neonatal intensive care unit (NICU)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of neonatal intensive care unit | – | –* 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 |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients admitted to the neonatal intensive care unit at the Creteil Intercommunal Hospital Center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Absence of Edi tube
- Palliative care situation
- Patient treated with curare
- Patients with neuromuscular disorders
- Accidental extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Time to reintubation
Time frame: 7 days
Reintubation rate
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 39289731Parrilla-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.
- Background: PubMed 37660179Scholten 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.
- Background: PubMed 19380428Hermeto 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.
- Background: PubMed 39118595Khodak 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.
- Background: PubMed 38553331Sant'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.
- Background: PubMed 33627331Shalish 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.
- Background: PubMed 30404739Shalish 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.
- Background: PubMed 39814054Hoff 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.
- Background: PubMed 29198532Choi 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.
- Background: PubMed 35040888Bell 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.
- Individual participant dataSharing planned: No. The DPI will not be disclosed and will be retained for only two years after the results are published
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Study of Predictors of Successful Extubation in Preterm Infants and Extubation Succeeded, run by Centre Hospitalier Intercommunal Creteil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emeric EG Genet, Medical Doctor (+33652555454, emeric.genet@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation success (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07709988, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.