Extubation FailureNeonatesNCT07764575
Predictors of Extubation Failure in Ventilated Neonates
An observational study of Extubation Failure and Neonates, run by Assiut University.
Trial summary
This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Extubation Failure, Neonates, NICU
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jun 2028
- How long will I take part?
- 1 Year
- 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 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: This study will be carried out in the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital
Who may be able to join
- Neonates (gestational age 28-44 weeks corrected) mechanically ventilated for ≥48 hours
- Planned extubation as determined by the treating neonatologist
- Hemodynamically stable at enrollment
Who cannot join
- Major congenital anomalies
- Neuromuscular disorders
- Thoracic malformations
- Inborn error of metabolism
- Unplanned/accidental extubation
About this study
This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.
Read the detailed description
Mechanical ventilation (MV) is life-saving in the neonatal intensive care unit (NICU), yet extubation timing remains one of the most consequential and poorly standardized decisions in neonatology. The rate of extubation failure (EF) increases from 20% in infants born at 28-31 weeks gestational age to more than 60% in very preterm infants born at less than 28 weeks gestational age, for several reasons including frequent or severe apneas, residual lung disease, immature respiratory drive, and the presence of an unstable patent ductus arteriosus (PDA) .
EF is defined as the need for reintubation within 72 hours of a planned extubation attempt, and its consequences are profound. EF not only prolongs the duration of MV but is independently associated with increased mortality, morbidity, length of hospital stay, and healthcare costs.
Clinical judgment, personal experience, bedside observation of blood gases, oxygen requirements, and ventilator settings are typically used to make decisions on whenever to extubate or not. Consequently, there are significant practical differences and a paucity of protocols to simplify the management of all components of the peri-extubation process, with decisions often being physician-dependent rather than evidence-based, which may lead to inappropriate extubation.
The emergence of point-of-care ultrasound (POCUS) and targeted neonatal echocardiography (TNE) has created new opportunities for objective, real-time, bedside physiological assessment. Lung ultrasound score (LUS), diaphragmtic thickening fraction (DTF) and excursion, arterial blood gas (ABG) analysis, and functional echocardiographic hemodynamic assessment, including left ventricular outflow tract velocity time integral (LVOT VTI), right ventricular outflow tract (RVOT), and patent ductus arteriosus (PDA) characterization, represent four physiologically independent domains that together capture the full spectrum of mechanisms underlying extubation failure. No validated multimodal bedside scoring tool combining all four domains currently exists in neonatology.
This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.
- Conditions
- Extubation Failure, Neonates, NICU
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 |
|---|---|---|
| Extubatuin sucess | Parameters of neonates who will be successed to be weaned | |
| Extubation failure | Parameters of neonates who will be failed to be weaned |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of functional echocardiography in predicting exutbation failure
The role of functional echocardiography in predicting exutbation failure
Measured: baseline
The role of Chest ultrasound in predicting extubation failure
The role of Chest ultrasound in predicting extubation failure
Measured: baseline
The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure
The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Sameh Abd El-Aleem Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764575
- Sponsor's protocol ID
- Extubation failure
- Acronym
- Neonates
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Extubation Failure in Ventilated Neonates
- ClinicalTrials.gov ID
- NCT07764575
- Acronym / sponsor ID
- Neonates / Extubation failure
- Conditions
- Extubation Failure, Neonates, NICU
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 14 Aug 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.
This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.
Detailed description
Mechanical ventilation (MV) is life-saving in the neonatal intensive care unit (NICU), yet extubation timing remains one of the most consequential and poorly standardized decisions in neonatology. The rate of extubation failure (EF) increases from 20% in infants born at 28-31 weeks gestational age to more than 60% in very preterm infants born at less than 28 weeks gestational age, for several reasons including frequent or severe apneas, residual lung disease, immature respiratory drive, and the presence of an unstable patent ductus arteriosus (PDA) .
EF is defined as the need for reintubation within 72 hours of a planned extubation attempt, and its consequences are profound. EF not only prolongs the duration of MV but is independently associated with increased mortality, morbidity, length of hospital stay, and healthcare costs.
Clinical judgment, personal experience, bedside observation of blood gases, oxygen requirements, and ventilator settings are typically used to make decisions on whenever to extubate or not. Consequently, there are significant practical differences and a paucity of protocols to simplify the management of all components of the peri-extubation process, with decisions often being physician-dependent rather than evidence-based, which may lead to inappropriate extubation.
The emergence of point-of-care ultrasound (POCUS) and targeted neonatal echocardiography (TNE) has created new opportunities for objective, real-time, bedside physiological assessment. Lung ultrasound score (LUS), diaphragmtic thickening fraction (DTF) and excursion, arterial blood gas (ABG) analysis, and functional echocardiographic hemodynamic assessment, including left ventricular outflow tract velocity time integral (LVOT VTI), right ventricular outflow tract (RVOT), and patent ductus arteriosus (PDA) characterization, represent four physiologically independent domains that together capture the full spectrum of mechanisms underlying extubation failure. No validated multimodal bedside scoring tool combining all four domains currently exists in neonatology.
This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubatuin sucess | – | –Parameters of neonates who will be successed to be weaned |
| Extubation failure | – | –Parameters of neonates who will be failed to be weaned |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be carried out in the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital
Key inclusion criteria (3 listed)
- Neonates (gestational age 28-44 weeks corrected) mechanically ventilated for ≥48 hours
- Planned extubation as determined by the treating neonatologist
- Hemodynamically stable at enrollment
Key exclusion criteria (5 listed)
- Major congenital anomalies
- Neuromuscular disorders
- Thoracic malformations
- Inborn error of metabolism
- Unplanned/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
The role of functional echocardiography in predicting exutbation failure
Time frame: baseline
The role of functional echocardiography in predicting exutbation failure
The role of Chest ultrasound in predicting extubation failure
Time frame: baseline
The role of Chest ultrasound in predicting extubation failure
The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure
Time frame: baseline
The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure
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 14 Aug 2026.
Related trials for Extubation Failure
Not yet recruitingObservational study
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
Extubation Success, Extubation Failure
Not yet recruiting
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation After Extubation in Neonates
Extubation Failure in Neonates
RecruitingObservational study
Characterization of Weaning Practices in ICUs of Global South Countries
Weaning From Mechanical Ventilation, Weaning Failure
Not yet recruiting
One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial
Airway Extubation, Weaning Mechanical Ventilation
Not yet recruiting
One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial
Airway Extubation, Extubation Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation Failure and Neonates, run by Assiut University.
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 5 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 14 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of functional echocardiography in predicting exutbation failure (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.