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NCT Number: NCT07764575

Predictors of Extubation Failure in Ventilated Neonates

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.

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Key information

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The role of functional echocardiography in predicting exutbation failure

    Time frame: baseline

    The role of functional echocardiography in predicting exutbation failure

  2. The role of Chest ultrasound in predicting extubation failure

    Time frame: baseline

    The role of Chest ultrasound in predicting extubation failure

  3. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: Neonates

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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