Respiratory Distress Syndrome, NewbornNCT07857304
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
An observational study of Respiratory Distress Syndrome, Newborn and Neonatal Respiratory Distress, run by Assiut University.
Trial summary
This cross-sectional study aims to evaluate the diagnostic accuracy of chest ultrasound in neonatal respiratory distress syndrome and to assess its potential prognostic value compared with chest X-ray. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 25 Feb 2028
- Phase
- Observational
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 Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates (≤35 weeks of gestation) with clinical respiratory distress presenting at Assiut University Children's Hospital.
Who may be able to join
- - Preterm neonates ≤35 weeks of gestation
- Clinical signs of respiratory distress within the first 24 hours of life
- Radiographic data suggestive of respiratory distress syndrome
- Written informed consent from parents or legal guardians
Who cannot join
- - Major congenital anomalies of the respiratory system
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chest Ultrasound as a Diagnostic and Prognostic Tool in the Management of Neonatal Respiratory Distress Syndrome Versus Chest X-ray
This cross-sectional study aims to evaluate the diagnostic accuracy of chest ultrasound in neonatal respiratory distress syndrome and to assess its potential prognostic value compared with chest X-ray.
Read the detailed description
Neonatal respiratory distress syndrome is a major cause of morbidity in preterm infants. Chest X-ray is traditionally used for diagnosis but involves ionizing radiation. Lung ultrasound is a bedside, radiation-free alternative that may also provide prognostic information.
This observational study will include preterm neonates (≤35 weeks of gestation) presenting with clinical respiratory distress within the first 24 hours of life. Chest ultrasound and chest X-ray findings will be compared to assess diagnostic performance and potential prognostic value.
- Keywords
- Lung ultrasound, Respiratory distress syndrome, Chest X-ray, Preterm neonates, Assiut
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Pulmonary Atelectasis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Preterm Neonates with Respiratory Distress | Preterm neonates (≤35 weeks of gestation) presenting with clinical and radiographic signs of respiratory distress syndrome within the first 24 hours of life who will undergo both chest ultrasound and chest X-ray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of chest ultrasound for diagnosis of respiratory distress syndrome
Sensitivity of chest ultrasound for the diagnosis of respiratory distress syndrome in preterm neonates, using chest X-ray as the reference standard.
Measured: Baseline
Secondary outcomes (6)
Specificity of chest ultrasound
Specificity of chest ultrasound for the diagnosis of respiratory distress syndrome.
Measured: Baseline
Positive predictive value of chest ultrasound
Positive predictive value of chest ultrasound for the diagnosis of respiratory distress syndrome.
Measured: Baseline
Negative predictive value of chest ultrasound
Negative predictive value of chest ultrasound for the diagnosis of respiratory distress syndrome.
Measured: Baseline
Overall diagnostic accuracy of chest ultrasound
Overall diagnostic accuracy of chest ultrasound for diagnosis of respiratory distress syndrome calculated as (true positives + true negatives) divided by total cases, using chest X-ray as reference standard.
Measured: Baseline
Proportion of neonates with white lung appearance on ultrasound
Proportion of preterm neonates showing white lung appearance on chest ultrasound.
Measured: Baseline
Proportion of neonates with abnormal pleural line on ultrasound
Proportion of preterm neonates showing abnormal or irregular pleural line on chest ultrasound.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completion28 Sep 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mousa Alisha, Assiut University
- Investigators
- Mohamed A fathy, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857304
- Sponsor's protocol ID
- LUS-RDS-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No