ClinicalTrials.gg
Not yet recruitingNCT07821632Updated Sep 16, 2026

Predictors of Prolonged Mechanical Ventilation in Preterm Infants

An observational study in Premature Birth, Respiration Failure and Bronchopulmonary Dysplasia, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 36 Weeks
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Premature Birth by Assiut University — 5 open to participants now, 5 under way, none of them phase 3. Premature Birth · Assiut University.

Started
2026
with 4 others
Observational
7 of 12
4 open now
Registered
10th of 12
by date

Among the 12 studies in Premature Birth by Assiut University, this one is one of 5 that started in 2026, is one of 7 observational ones, and was the 10th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

Observationalthis study7 · 4 open
Phase 22 · 0 open
No phase1 · 1 open
Phase 2/31 · 0 open
Phase 41 · 0 open

By the year they started

First in 2012; this study’s year is marked. 5 started in 2026.

What they test

Size and results

Median enrollment 94 across the 5 interventional studies, 100 across the 7 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Premature Birth by Assiut University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Premature Birth
  • Respiration Failure
  • Bronchopulmonary Dysplasia

Keywords

  • Prolonged mechanical
  • ventilation
  • Preterm infants
  • NICU
  • Predictors
  • Extubation
  • Assiut
04

Who can participate

Ages eligible
Up to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • - Infants born after 37 weeks of gestation
  • Major congenital anomalies
  • Chromosomal abnormalities
  • Congenital neuromuscular disorders
  • Cyanotic congenital heart disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Occurrence of prolonged mechanical ventilation

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

    Time frame: Up to 30 days

Secondary outcomes

  1. Duration of invasive mechanical ventilation

    Total number of days of invasive mechanical ventilation.

    Time frame: Up to 30 days

  2. Successful extubation rate

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

    Time frame: Up to 30 days

  3. Incidence of bronchopulmonary dysplasia

    Proportion of infants diagnosed with bronchopulmonary dysplasia.

    Time frame: Up to 30 days

  4. Incidence of neonatal sepsis

    Proportion of infants diagnosed with neonatal sepsis.

    Time frame: Up to 30 days

  5. Duration of NICU stay

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

    Time frame: Up to 30 days

  6. In-hospital mortality

    Proportion of infants who die before hospital discharge.

    Time frame: Up to 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 36822179 ↗
  • Zeiler 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 26721868 ↗
  • La 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 35160003 ↗
  • Vliegenthart 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 12 months is below that.

Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 16, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Sep 25, 2027
CompletionEst.
Apr 10, 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07821632
Lead sponsor
Assiut University
Responsible party
Demiana Youssef Zakaria Ghaly (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 25, 2027 (estimated)
Completion
Apr 10, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Demiana Y Zakaria, Resident
Contact
Demiana.16266368@med.aun.edu.eg
0 1280798683
Jaafar I Mohammed, prof
study chair · pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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