Premature BirthNCT07821632
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
An observational study of Premature Birth and Respiration Failure, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Premature Birth, Respiration Failure, Bronchopulmonary Dysplasia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 10 Apr 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital who require invasive mechanical ventilation.
Who may be able to join
- - 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
Who cannot join
- - Infants born after 37 weeks of gestation
- Major congenital anomalies
- Chromosomal abnormalities
- Congenital neuromuscular disorders
- Cyanotic congenital heart disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Keywords
- Prolonged mechanical, ventilation, Preterm infants, NICU, Predictors, Extubation, Assiut
- Medical subject headings
- Premature Birth, Respiratory Insufficiency, Bronchopulmonary Dysplasia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of prolonged mechanical ventilation
Proportion of preterm infants who require invasive mechanical ventilation for more than 7 days or frequent reintubation.
Measured: Up to 30 days
Secondary outcomes (6)
Duration of invasive mechanical ventilation
Total number of days of invasive mechanical ventilation.
Measured: Up to 30 days
Successful extubation rate
Proportion of infants who are successfully extubated without re-intubation within 48-72 hours.
Measured: Up to 30 days
Incidence of bronchopulmonary dysplasia
Proportion of infants diagnosed with bronchopulmonary dysplasia.
Measured: Up to 30 days
Incidence of neonatal sepsis
Proportion of infants diagnosed with neonatal sepsis.
Measured: Up to 30 days
Duration of NICU stay
Length of stay in the neonatal intensive care unit in days.
Measured: Up to 30 days
In-hospital mortality
Proportion of infants who die before hospital discharge.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demiana Youssef Zakaria Ghaly, Assiut University
- Investigators
- Jaafar I Mohammed, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821632
- Sponsor's protocol ID
- PMV-Preterm-NICU-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Z, He Z, Wang J, Kong G. RNA splicing factors in normal hematopoiesis and hematologic malignancies: novel therapeutic targets and strategies. J Leukoc Biol. 2023 Feb 1;113(2):149-163. doi: 10.1093/jleuko/qiac015.
PubMed 36822179Zeiler SR, Hubbard R, Gibson EM, Zheng T, Ng K, O'Brien R, Krakauer JW. Paradoxical Motor Recovery From a First Stroke After Induction of a Second Stroke: Reopening a Postischemic Sensitive Period. Neurorehabil Neural Repair. 2016 Sep;30(8):794-800. doi: 10.1177/1545968315624783. Epub 2015 Dec 31.
PubMed 26721868La Croce G, Naspro R, Finati M, Pellucchi F, Sodano M, Manica M, Catellani M, Gianatti A, Roscigno M, Da Pozzo LF. The Accuracy of Transurethral Bladder Resection in Detecting Bladder Cancer Histological Variants and Their Prognostic Value at Radical Cystectomy. J Clin Med. 2022 Jan 22;11(3):550. doi: 10.3390/jcm11030550.
PubMed 35160003Vliegenthart RJS, van Kaam AH, Aarnoudse-Moens CSH, van Wassenaer AG, Onland W. Duration of mechanical ventilation and neurodevelopment in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F631-F635. doi: 10.1136/archdischild-2018-315993. Epub 2019 Mar 20.
PubMed 30894396