The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
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 Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedAugust 16, 2022
August 1, 2022
5 months
August 9, 2022
August 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound
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.
6 months
Eligibility Criteria
The study will be conducted on neonates admitted to NICU.
You may qualify if:
- Preterm infants from 28-36 weeks gestation
- In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .
You may not qualify if:
- \) Significant congenital anomalies including cardiac, abdominal or respiratory.
- \) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Resident at Pediatrics hospital ainshams university
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 10, 2022
Study Start
August 1, 2022
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
August 16, 2022
Record last verified: 2022-08