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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06372951
Other study ID # Lung ultrasound in neonate
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date March 2026

Study information

Verified date April 2024
Source Assiut University
Contact Esraa Talat Fawzy, Master
Phone 01061846361
Email esraatalat883@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray .


Description:

- Lung disease is the most common cause of neonatal respiratory distress. - It can result in respiratory failure and death in severe cases. - The mortality rate is approximately 11%:32%. - Identification of the etiology of lung disease is important for neonatologists. - Traditionally, chest X-ray has been considered as the most valuable imaging modality for the diagnosis of lung diseases, but it unavoidably causes radiation damage to the patient. - Neonates are susceptible to radiation because they have rapidly dividing cells that cannot repair mutated DNA. - The risk of cancer induction in infants receiving a single small dose of radiation is 2-3 times higher than the average population and 6-9 times higher than the risk from an exposure of a 60-year-old patient. - New imaging modalities have been introduced in clinical practice in recent years such as lung ultrasound. - One of the most common causes of neonatal respiratory distress that can be diagnosed by ultrasound is :Respiratory Distress Syndrome: - Respiratory distress syndrome.. is a major cause of neonatal mortality. - It mainly occur in preterm infants due to structural and functional lung immaturity. - Pulmonary surfactant insufficiency is an important pathogenesis in respiratory distress syndrome. - The ultrasonic features of respiratory distress syndrome are: Compact B-Lines, white lung appearance, abnormality in pleural line (thick and irregular),lung consolidation. - Lung ultrasound has the advantages of : - Non-ionizing. - Easy to operate. - Low coast. - Portable for bedside use. - The imaging is performed in real-time. - Thus making it as a potential tool to be used in neonatal intensive care units.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 132
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 1 Day to 28 Days
Eligibility Inclusion Criteria: - Neonates in neonatal intensive care units Exclusion Criteria: - Patients with poor-quality of lung ultrasound image. - Subcutaneous emphysema.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound
A device that use ultrasonic waves as a way to image the internal organs and tissues of the body in order to diagnose the different diseases.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Identifying causes of neonatal respiratory distress - To evaluate lung ultrasound accuracy and reliability in diagnosing pulmonary disease in neonates in comparison to x rays Baseline
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