NCT07821632

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Apr 2028

First Submitted

Initial submission to the registry

September 8, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2028

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 8, 2026

Last Update Submit

September 10, 2026

Conditions

Premature BirthBronchopulmonary DysplasiaRespiration Failure

Keywords

Prolonged mechanicalventilationPreterm infantsNICUPredictorsExtubationAssiut

Outcome Measures

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.

    Up to 30 days

Secondary Outcomes (6)

  • Duration of invasive mechanical ventilation

    Up to 30 days

  • Successful extubation rate

    Up to 30 days

  • Incidence of bronchopulmonary dysplasia

    Up to 30 days

  • Incidence of neonatal sepsis

    Up to 30 days

  • Duration of NICU stay

    Up to 30 days

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 36822179BACKGROUND

  • 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.

    PMID: 26721868BACKGROUND

  • 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.

    PMID: 35160003BACKGROUND

  • 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.

    PMID: 30894396BACKGROUND

MeSH Terms

Conditions

Premature BirthRespiratory InsufficiencyBronchopulmonary DysplasiaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jaafar I Mohammed, prof

    pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Demiana Y Zakaria, Resident

CONTACT

0 1280798683Demiana.16266368@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 16, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

April 10, 2028

Last Updated

September 16, 2026

Record last verified: 2026-09