Lung Ultrasound in Neonatal Intensive Care Units

Neonatal Respiratory Distress Clinical Trial

Official title:

Role of Lung Ultrasound in Assessment of Neonatal Respiratory Distress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372951
• Other study ID #: Lung ultrasound in neonate
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

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