NCT06372951

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

November 29, 2023

Last Update Submit

April 16, 2024

Conditions

Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

UltrasoundDEVICE

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.

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Neonates in neonatal intensive care units

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ihab Mansour Mohamed, Prof.

    Assiut University

    STUDY DIRECTOR

  • Kawsar Abdel Halim Mohamed, Lecturer

    Assiut University

    STUDY DIRECTOR

  • Azhar Arabi Mohammed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Esraa Talat Fawzy, Master

CONTACT

01061846361esraatalat883@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: Assistant Lecturer

Study Record Dates

First Submitted

November 29, 2023

First Posted

April 18, 2024

Study Start

May 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 18, 2024

Record last verified: 2024-04