Chest Ultrasound Versus Chest X-ray in Neonatal Respiratory Distress Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 24
SponsorAssiut University
About this trial
This cross-sectional study aims to evaluate the diagnostic accuracy of chest ultrasound in the diagnosis of respiratory distress syndrome among preterm neonates in comparison with chest X-ray.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
- Major congenital anomalies of the respiratory system
Trial population
Preterm neonates (≤35 weeks of gestation) with clinical respiratory distress presenting at Assiut University Children's Hospital.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
82 Participants
are grouped into 1 trial groupGroup A: Single cohort: Preterm Neonates with Respiratory Distress
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary outcomes
1
Specificity of chest ultrasound
Specificity of chest ultrasound for the diagnosis of respiratory distress syndrome.
Time frame
Baseline2
Positive predictive value of chest ultrasound
Positive predictive value of chest ultrasound for the diagnosis of respiratory distress syndrome.
Time frame
Baseline3
Negative predictive value of chest ultrasound
Negative predictive value of chest ultrasound for the diagnosis of respiratory distress syndrome.
Time frame
Baseline4
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.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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