An observational study in Neonatal Pneumonia, Respiratory Distress Syndrome and Pneumonia Neonatal, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Minute to 28 Days. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Assiut University · Observational
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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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 282 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: At the time of clinical suspicion of pneumonia (Baseline)
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).
Time frame: 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).
Time frame: Baseline
Risk factors associated with neonatal pneumonia
Antenatal, perinatal, and postnatal risk factors associated with the diagnosis of neonatal pneumonia.
Time frame: Baseline
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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