Lung Ultrasound in Neonatal Intensive Care Units

NCT ID: NCT06372951

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-03-31

Brief Summary

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

Detailed 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.

Conditions

Neonatal Respiratory Distress

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Neonates in neonatal intensive care units

Exclusion Criteria

• Patients with poor-quality of lung ultrasound image.
• Subcutaneous emphysema.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Talat Fawzy

: Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ihab Mansour Mohamed, Prof.

Role: STUDY_DIRECTOR

Assiut University

Kawsar Abdel Halim Mohamed, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Azhar Arabi Mohammed, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Esraa Talat Fawzy, Master

Role: CONTACT

esraatalat883@gmail.com

01061846361

Other Identifiers

Lung ultrasound in neonate

Identifier Type: -

Identifier Source: org_study_id