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NCT Number: NCT07821632

Predictors of Prolonged Mechanical Ventilation in Preterm Infants

This prospective cohort study aims to identify the independent predictors of prolonged mechanical ventilation in preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital.

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Key information

Conditions

Premature Birth Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiration Failure Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Observational

About this study

Prolonged mechanical ventilation in preterm infants is associated with increased morbidity including bronchopulmonary dysplasia and neurodevelopmental impairment. This prospective observational study will include preterm infants (born before 37 completed weeks) who require invasive mechanical ventilation.

Infants will be classified into two groups according to the duration of invasive mechanical ventilation: prolonged (>7 days or frequent reintubation) and non-prolonged (≤7 days). clinical, perinatal, and laboratory predictors of prolonged mechanical ventilation will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Preterm infants born before 37 completed weeks of gestation
  • Admission to the NICU within the neonatal period
  • Requirement for invasive mechanical ventilation
  • Written informed consent from parents or legal guardians

Exclusion criteria

  • - Infants born after 37 weeks of gestation
  • Major congenital anomalies
  • Chromosomal abnormalities
  • Congenital neuromuscular disorders
  • Cyanotic congenital heart disease

Treatment and study plan

Primary outcomes

  1. Occurrence of prolonged mechanical ventilation

    Time frame: Up to 30 days

    Proportion of preterm infants who require invasive mechanical ventilation for more than 7 days or frequent reintubation.

Secondary outcomes

  1. Duration of invasive mechanical ventilation

    Time frame: Up to 30 days

    Total number of days of invasive mechanical ventilation.

  2. Successful extubation rate

    Time frame: Up to 30 days

    Proportion of infants who are successfully extubated without re-intubation within 48-72 hours.

  3. Incidence of bronchopulmonary dysplasia

    Time frame: Up to 30 days

    Proportion of infants diagnosed with bronchopulmonary dysplasia.

  4. Incidence of neonatal sepsis

    Time frame: Up to 30 days

    Proportion of infants diagnosed with neonatal sepsis.

  5. Duration of NICU stay

    Time frame: Up to 30 days

    Length of stay in the neonatal intensive care unit in days.

  6. In-hospital mortality

    Time frame: Up to 30 days

    Proportion of infants who die before hospital discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Demiana Y Zakaria, Resident

CONTACT

[email protected]

0 1280798683

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Predictors of Prolonged Mechanical Ventilation in Preterm Infants Admitted to Neonatal Intensive Care Unit of Assiut University Children Hospital

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 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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