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Chest X-Ray Versus Lung Ultrasound in Neonatal Pneumonia

Chest X-Ray Versus Chest Ultrasound in Diagnosis of Neonatal Pneumonia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07807514
Enrollment
100
Registered
2026-09-08
Start date
2026-09-02
Completion date
2028-07-20
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Pneumonia, Pneumonia Neonatal, Respiratory Distress Syndrome

Keywords

Point-of-care ultrasound, Diagnostic accuracy, Chest X-ray, Lung ultrasound, Neonatal pneumonia

Brief 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.

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 28 Days
Healthy volunteers
No

Inclusion criteria

* \- 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

Exclusion criteria

* \- Major congenital pulmonary or cardiac structural malformations that would confound imaging interpretation * Lethal congenital anomalies or chromosomal abnormalities incompatible with survival

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of lung ultrasound versus chest X-rayAt 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.

Secondary

MeasureTime frameDescription
Comparison of radiographic and sonographic findingsBaselineDescription 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).
Correlation with clinical severityBaselineCorrelation between chest X-ray grading and lung ultrasound scores with clinical severity indices of neonatal respiratory distress (oxygenation index, FiO2 requirement, respiratory support level).
Risk factors associated with neonatal pneumoniaBaselineAntenatal, perinatal, and postnatal risk factors associated with the diagnosis of neonatal pneumonia.

Contacts

CONTACTRana H Rayan, Resident
Rana.18313199@med.aun.edu.eg+20 10 69579624
STUDY_CHAIRKhaled A Sanousy, prof

Pediatrics Department, Assiut University Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026