Neonatal PneumoniaNCT07807514
Chest X-Ray Versus Lung Ultrasound in Neonatal Pneumonia
An observational study of Neonatal Pneumonia and Respiratory Distress Syndrome, run by Assiut University.
Trial summary
This prospective observational study aims to compare the diagnostic accuracy of chest X-ray versus lung ultrasound in the diagnosis of neonatal pneumonia among neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Neonatal Pneumonia, Respiratory Distress Syndrome, Pneumonia Neonatal
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 20 Jul 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 minute to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Term and preterm neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital with clinical diagnosis of pneumonia within the first 28 days of life.
Who may be able to join
- - Neonates (term and preterm) admitted to the NICU
- Clinical diagnosis of pneumonia within the first 28 days of life
- Written informed consent from parents or legal guardians
Who cannot join
- - Major congenital pulmonary or cardiac structural malformations that would confound imaging interpretation
- Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
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 X-Ray Versus Chest Ultrasound in Diagnosis of Neonatal Pneumonia
This prospective observational study aims to compare the diagnostic accuracy of chest X-ray versus lung ultrasound in the diagnosis of neonatal pneumonia among neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
Read the detailed description
Neonatal pneumonia is a leading cause of respiratory morbidity and mortality in the neonatal period. Chest X-ray has traditionally been the reference imaging modality, but it involves ionizing radiation and has moderate sensitivity. Lung ultrasound is a radiation-free, bedside alternative that has shown promising diagnostic performance.
This prospective study will include term and preterm neonates admitted to the NICU with clinical suspicion of pneumonia within the first 28 days of life. All participants will undergo both portable chest X-ray and standardized lung ultrasound performed by trained examiners blinded to each other's findings. Diagnostic accuracy of both modalities will be compared against a composite clinical reference standard.
- Keywords
- Point-of-care ultrasound, Diagnostic accuracy, Chest X-ray, Lung ultrasound, Neonatal pneumonia
- Medical subject headings
- 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: Neonates with clinical suspicion of pneumonia | Term and preterm neonates admitted to the NICU with clinical signs suggestive of pneumonia who will undergo both chest X-ray and lung ultrasound for diagnostic comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of lung ultrasound versus chest X-ray
Sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound compared with chest X-ray for the diagnosis of neonatal pneumonia, using a composite clinical reference standard.
Measured: At the time of clinical suspicion of pneumonia (Baseline)
Secondary outcomes (3)
Comparison of radiographic and sonographic findings
Description and comparison of chest X-ray findings (opacities, air bronchograms, pleural effusion) and lung ultrasound findings (subpleural consolidation, dynamic air bronchograms, B-lines, pleural line abnormalities).
Measured: Baseline
Correlation with clinical severity
Correlation between chest X-ray grading and lung ultrasound scores with clinical severity indices of neonatal respiratory distress (oxygenation index, FiO2 requirement, respiratory support level).
Measured: Baseline
Risk factors associated with neonatal pneumonia
Antenatal, perinatal, and postnatal risk factors associated with the diagnosis of neonatal pneumonia.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start2 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Hosny Rayan Manaa, Assiut University
- Investigators
- Khaled A Sanousy, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807514
- Sponsor's protocol ID
- CXR-LUS-Neonatal-Pneumonia-Ass
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duda JP, Love GD, Rogov VI, Melnik DS, Blumenberg M, Grazhdankin DV. Understanding the geobiology of the terminal Ediacaran Khatyspyt Lagerstatte (Arctic Siberia, Russia). Geobiology. 2020 Nov;18(6):643-662. doi: 10.1111/gbi.12412. Epub 2020 Sep 3.
PubMed 32881267Batts KP, Atwaibi M, Weinberg DI, McCabe RP. Significance of serrated epithelial change in inflammatory bowel disease. Postgrad Med. 2021 Jan;133(1):66-70. doi: 10.1080/00325481.2020.1802138. Epub 2020 Sep 29.
PubMed 32746680Shi X, Qin Z, Liang Z, Meng D, Li J, Zhang S, Dai R, Hou E, Xin W, Liu H, Xu H, Liu Y. Polarization-selective absorptive and transmissive metamaterials. Opt Express. 2022 Jun 6;30(12):20532-20542. doi: 10.1364/OE.456849.
PubMed 36224795Piazza V, Gambardella C, Costa E, Miroglio R, Faimali M, Garaventa F. Cold storage effects on lethal and sublethal responses of Amphibalanus amphitrite Nauplii. Ecotoxicology. 2022 Sep;31(7):1078-1086. doi: 10.1007/s10646-022-02571-1. Epub 2022 Jul 15.
PubMed 35838933
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest X-Ray Versus Chest Ultrasound in Diagnosis of Neonatal Pneumonia
- ClinicalTrials.gov ID
- NCT07807514
- Acronym / sponsor ID
- CXR-LUS-Neonatal-Pneumonia-Ass
- Keywords
- Point-of-care ultrasound, Diagnostic accuracy, Chest X-ray, Lung ultrasound, Neonatal pneumonia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 20 Jul 2028 (estimated)
- First posted
- 8 Sep 2026 (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.
This prospective observational study aims to compare the diagnostic accuracy of chest X-ray versus lung ultrasound in the diagnosis of neonatal pneumonia among neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
Detailed description
Neonatal pneumonia is a leading cause of respiratory morbidity and mortality in the neonatal period. Chest X-ray has traditionally been the reference imaging modality, but it involves ionizing radiation and has moderate sensitivity. Lung ultrasound is a radiation-free, bedside alternative that has shown promising diagnostic performance.
This prospective study will include term and preterm neonates admitted to the NICU with clinical suspicion of pneumonia within the first 28 days of life. All participants will undergo both portable chest X-ray and standardized lung ultrasound performed by trained examiners blinded to each other's findings. Diagnostic accuracy of both modalities will be compared against a composite clinical reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Neonates with clinical suspicion of pneumonia | – | –Term and preterm neonates admitted to the NICU with clinical signs suggestive of pneumonia who will undergo both chest X-ray and lung ultrasound for diagnostic comparison. |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and preterm neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital with clinical diagnosis of pneumonia within the first 28 days of life.
Key inclusion criteria (3 listed)
- - Neonates (term and preterm) admitted to the NICU
- Clinical diagnosis of pneumonia within the first 28 days of life
- Written informed consent from parents or legal guardians
Key exclusion criteria (2 listed)
- - Major congenital pulmonary or cardiac structural malformations that would confound imaging interpretation
- Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of lung ultrasound versus chest X-ray
Time frame: At the time of clinical suspicion of pneumonia (Baseline)
Sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound compared with chest X-ray for the diagnosis of neonatal pneumonia, using a composite clinical reference standard.
3 secondary outcomes
Comparison of radiographic and sonographic findings
Time frame: Baseline
Correlation with clinical severity
Time frame: Baseline
Risk factors associated with neonatal pneumonia
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 32881267Duda JP, Love GD, Rogov VI, Melnik DS, Blumenberg M, Grazhdankin DV. Understanding the geobiology of the terminal Ediacaran Khatyspyt Lagerstatte (Arctic Siberia, Russia). Geobiology. 2020 Nov;18(6):643-662. doi: 10.1111/gbi.12412. Epub 2020 Sep 3.
- Background: PubMed 32746680Batts KP, Atwaibi M, Weinberg DI, McCabe RP. Significance of serrated epithelial change in inflammatory bowel disease. Postgrad Med. 2021 Jan;133(1):66-70. doi: 10.1080/00325481.2020.1802138. Epub 2020 Sep 29.
- Background: PubMed 36224795Shi X, Qin Z, Liang Z, Meng D, Li J, Zhang S, Dai R, Hou E, Xin W, Liu H, Xu H, Liu Y. Polarization-selective absorptive and transmissive metamaterials. Opt Express. 2022 Jun 6;30(12):20532-20542. doi: 10.1364/OE.456849.
- Background: PubMed 35838933Piazza V, Gambardella C, Costa E, Miroglio R, Faimali M, Garaventa F. Cold storage effects on lethal and sublethal responses of Amphibalanus amphitrite Nauplii. Ecotoxicology. 2022 Sep;31(7):1078-1086. doi: 10.1007/s10646-022-02571-1. Epub 2022 Jul 15.
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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.
Khaled A Sanousy, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Pneumonia and Respiratory Distress Syndrome, 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 3 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: opening soon, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana H Rayan, Resident (+20 10 69579624, Rana.18313199@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of lung ultrasound versus chest X-ray (time frame: At the time of clinical suspicion of pneumonia (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807514, which also lists 4 linked publications.
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 8 Sep 2026.