Lung Ultrasound in Neonatal Intensive Care Units | NCT06372951

Studies
Lung Ultrasound in Neonatal Intensive Care Units

NCT06372951

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 18, 2024Actual

Enrollment

132Estimated

Phase

Not provided

Conditions

Neonatal Respiratory Distress

Interventions

Ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Estimated

Primary Completion Date

Mar 2026Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Nov 29, 2023

First Submission Date that Met QC Criteria

Apr 16, 2024

First Posted Date

Apr 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Esraa Talat Fawzy, : Assistant Lecturer, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

132Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neonates in neonatal intensive care units

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

Study Population

Nenates in the neonatal intensive care units who suffering from respiratory distress.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esraa Talat Fawzy, Master	Contact	01061846361		esraatalat883@gmail.com

Overall Officials

Name	Affiliation	Role
Ihab Mansour Mohamed, Prof.	Assiut University	Study Director
Kawsar Abdel Halim Mohamed, Lecturer	Assiut University	Study Director
Azhar Arabi Mohammed, Lecturer

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided