Predictors of Extubation Failure in Ventilated Neonates (Neonates)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Neonates (gestational age 28-44 weeks corrected) mechanically ventilated for ≥48 hours
- Planned extubation as determined by the treating neonatologist
- Hemodynamically stable at enrollment
Exclusion Criteria:
- Major congenital anomalies
- Neuromuscular disorders
- Thoracic malformations
- Inborn error of metabolism
- Unplanned/accidental extubation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The role of functional echocardiography in predicting exutbation failure
Time Frame: baseline
|
The role of functional echocardiography in predicting exutbation failure
|
baseline
|
|
The role of Chest ultrasound in predicting extubation failure
Time Frame: baseline
|
The role of Chest ultrasound in predicting extubation failure
|
baseline
|
|
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
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Extubation failure
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.