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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Prolonged Mechanical Ventilation in Preterm Infants Admitted to Neonatal Intensive Care Unit of Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07821632
- Acronym / sponsor ID
- PMV-Preterm-NICU-Assiut-2026
- Keywords
- Prolonged mechanical, ventilation, Preterm infants, NICU, Predictors, Extubation, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital who require invasive mechanical ventilation.
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (5 listed)
- - Infants born after 37 weeks of gestation
- Major congenital anomalies
- Chromosomal abnormalities
- Congenital neuromuscular disorders
- Cyanotic congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Duration of invasive mechanical ventilation
Time frame: Up to 30 days
Successful extubation rate
Time frame: Up to 30 days
Incidence of bronchopulmonary dysplasia
Time frame: Up to 30 days
Incidence of neonatal sepsis
Time frame: Up to 30 days
Duration of NICU stay
Time frame: Up to 30 days
In-hospital mortality
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 36822179Li 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.
- Background: PubMed 26721868Zeiler 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.
- Background: PubMed 35160003La 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.
- Background: PubMed 30894396Vliegenthart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaafar I Mohammed, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Respiration Failure, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demiana Y Zakaria, Resident (0 1280798683, Demiana.16266368@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of prolonged mechanical ventilation (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821632, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.