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Predictors of Extubation Failure in Ventilated Neonates

Predictors of Extubation Failure in Ventilated Neonates

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07764575
Acronym
Neonates
Enrollment
124
Registered
2026-08-14
Start date
2026-12-01
Completion date
2028-06-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation Failure, Neonates, NICU

Brief 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.

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
The role of functional echocardiography in predicting exutbation failurebaselineThe role of functional echocardiography in predicting exutbation failure
The role of Chest ultrasound in predicting extubation failurebaselineThe role of Chest ultrasound in predicting extubation failure
The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failurebaselineThe role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026