Clincosm LogoSign in Get a demo

The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates

Sponsor
Noha Saied Ibrahim (Other)
Overall Status
Recruiting
CT.gov ID
NCT05495763
Collaborator
(none)
30
Enrollment
1
Location
5
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity.

This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound [6 months]

      Using Ultrasound to measure Intercostal Muscles thickness and diaphragmatic thickness and excursion for assessing the impact of the mechanical ventilation on muscle power predicting weaning from ventilation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Minutes to 28 Days
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Preterm infants from 28-36 weeks gestation

    2. In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .

    Exclusion Criteria:
      1. Significant congenital anomalies including cardiac, abdominal or respiratory.
    1. Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Cairo Egypt

    Sponsors and Collaborators

    • Noha Saied Ibrahim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha Saied Ibrahim, Resident at Pediatrics hospital ainshams university, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05495763
    Other Study ID Numbers:
    • Noha ibrahim
    First Posted:
    Aug 10, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 16, 2022