Predictors of Prolonged Mechanical Ventilation in Preterm Infants

September 10, 2026 updated by: Demiana Youssef Zakaria Ghaly, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Demiana Y Zakaria, Resident
Phone Number: 0 1280798683
Email: Demiana.16266368@med.aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital who require invasive mechanical ventilation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Prolonged Mechanical Ventilation Preterm infants who require invasive mechanical ventilation for more than 7 days or frequent reintubation
Non-Prolonged Mechanical Ventilation Preterm infants who require invasive mechanical ventilation for ≤7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of NICU stay Time Frame: Up to 30 days	Length of stay in the neonatal intensive care unit in days.	Up to 30 days
Duration of invasive mechanical ventilation Time Frame: Up to 30 days	Total number of days of invasive mechanical ventilation.	Up to 30 days
Successful extubation rate Time Frame: Up to 30 days	Proportion of infants who are successfully extubated without re-intubation within 48-72 hours.	Up to 30 days
Incidence of bronchopulmonary dysplasia Time Frame: Up to 30 days	Proportion of infants diagnosed with bronchopulmonary dysplasia.	Up to 30 days
Incidence of neonatal sepsis Time Frame: Up to 30 days	Proportion of infants diagnosed with neonatal sepsis.	Up to 30 days
In-hospital mortality Time Frame: Up to 30 days	Proportion of infants who die before hospital discharge.	Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Chair: Jaafar I Mohammed, prof, pediatrics Department, Assiut University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

April 10, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PMV-Preterm-NICU-Assiut-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.

Predictors of Prolonged Mechanical Ventilation in Preterm Infants