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Not yet recruitingNCT07857304Updated Oct 5, 2026

Chest Ultrasound Versus Chest X-ray in Neonatal Respiratory Distress Syndrome

An observational study in Respiratory Distress Syndrome, Newborn and Neonatal Respiratory Distress, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Assiut University · Observational

Updated Oct 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
82
Ages
Up to 24 Hours
Sex
All
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Study summary

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.

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.

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.

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Conditions studied

  • Respiratory Distress Syndrome, Newborn
  • Neonatal Respiratory Distress

Keywords

  • Lung ultrasound
  • Respiratory distress syndrome
  • Chest X-ray
  • Preterm neonates
  • Assiut
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In context

Respiratory Distress Syndrome, Newborn

1,179 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 161 are open to participants now.

This study's planned enrollment of 82 is below the median of 100 across 388 observational studies indexed under Respiratory Distress Syndrome, Newborn.

Browse Respiratory Distress Syndrome, Newborn studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Preterm neonates (≤35 weeks of gestation) with clinical respiratory distress presenting at Assiut University Children's Hospital.

Inclusion criteria

  • - 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

Exclusion criteria

Exclusion Criteria:

  • - Major congenital anomalies of the respiratory system
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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: Baseline

Secondary outcomes

  1. Specificity of chest ultrasound

    Specificity of chest ultrasound for the diagnosis of respiratory distress syndrome.

    Time frame: Baseline

  2. Positive predictive value of chest ultrasound

    Positive predictive value of chest ultrasound for the diagnosis of respiratory distress syndrome.

    Time frame: Baseline

  3. Negative predictive value of chest ultrasound

    Negative predictive value of chest ultrasound for the diagnosis of respiratory distress syndrome.

    Time frame: Baseline

  4. 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: Baseline

  5. Proportion of neonates with white lung appearance on ultrasound

    Proportion of preterm neonates showing white lung appearance on chest ultrasound.

    Time frame: Baseline

  6. Proportion of neonates with abnormal pleural line on ultrasound

    Proportion of preterm neonates showing abnormal or irregular pleural line on chest ultrasound.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07857304
Lead sponsor
Assiut University
Responsible party
Mariam Mousa Alisha (Resident Physician, Department of Pediatrics, Assiut University) — Principal investigator
First posted
Oct 5, 2026
Start date
Sep 28, 2026 (estimated)
Primary completion
Sep 28, 2027 (estimated)
Completion
Feb 25, 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

Mariam m Elisha, Resident
Contact
mmariammousa@gmail.com
+20 12 08409555
Mohamed A fathy, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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