Neonatal Respiratory DistressNCT06372951
Lung Ultrasound in Neonatal Intensive Care Units
An observational study of Neonatal Respiratory Distress, run by Assiut University.
Trial summary
Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray . Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Nenates in the neonatal intensive care units who suffering from respiratory distress.
Who may be able to join
- Neonates in neonatal intensive care units
Who cannot join
- Patients with poor-quality of lung ultrasound image.
- Subcutaneous emphysema.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Lung Ultrasound in Assessment of Neonatal Respiratory Distress
Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray .
Read the 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
- Being tested
- Ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying causes of neonatal respiratory distress
- To evaluate lung ultrasound accuracy and reliability in diagnosing pulmonary disease in neonates in comparison to x rays
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Talat Fawzy, Assiut University
- Investigators
- Ihab Mansour Mohamed, Prof., Study director, Assiut UniversityKawsar Abdel Halim Mohamed, Lecturer, Study director, Assiut UniversityAzhar Arabi Mohammed, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372951
- Sponsor's protocol ID
- Lung ultrasound in neonate
- Status last verified
- Apr 2024
- First submitted
- 29 Nov 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasound in Assessment of Neonatal Respiratory Distress
- ClinicalTrials.gov ID
- NCT06372951
- Acronym / sponsor ID
- Lung ultrasound in neonate
- Conditions
- Neonatal Respiratory Distress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Nenates in the neonatal intensive care units who suffering from respiratory distress.
Key inclusion criteria (1 listed)
- Neonates in neonatal intensive care units
Key exclusion criteria (2 listed)
- Patients with poor-quality of lung ultrasound image.
- Subcutaneous emphysema.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundA 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. | Device | – |
Primary outcome
Identifying causes of neonatal respiratory distress
Time frame: Baseline
- To evaluate lung ultrasound accuracy and reliability in diagnosing pulmonary disease in neonates in comparison to x rays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihab Mansour Mohamed, Prof. study director
Assiut University
Kawsar Abdel Halim Mohamed, Lecturer study director
Assiut University
Azhar Arabi Mohammed, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Distress, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Talat Fawzy, Master (01061846361, esraatalat883@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying causes of neonatal respiratory distress (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.