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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04722016
Other study ID # GO-LUNG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date June 1, 2020

Study information

Verified date January 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study. We used bed side ultrasound as the first line tecnique for lung imaging. X-ray were taken in cases with increasing respiratory distress in spite of treatment according to diagnosis depending on USG findings. We calculated decreased number of chest X-ray for every patient and evaluated the estimated decrease in radiation exposure.


Description:

Background: Chest X-ray is commonly used as first line imaging method to diagnose the reason of respiratory distress in NICUs. Lung ultrasound is a new diagnostic tool for lung imaging, and this method has been used more common recently in NICUs. Objectives: We aimed to determine the decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. Methods: From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study. We used bed side ultrasound as the first line tecnique for lung imaging. X-ray were taken in cases with increasing respiratory distress in spite of treatment according to diagnosis depending on USG findings. We calculated decreased number of chest X-ray for every patient and evaluated the estimated decrease in radiation exposure.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility Inclusion Criteria: - Term or preterm neonates with respiratory distress that started within the first 24 h after birth were included if they showed at admission signs of respiratory distress defined as: tachypnea (respiratory rate >60 breaths/min), intercostal/subcostal retractions, grunting, or FiO2 requirement >0.21. Exclusion Criteria: - Patients with a diagnosis of major malformations or chromosomal abnormalities, inherited metabolic diseases, congenital muscle disease-hypotonicity, hypoxic ischemic encephalopathy were not enrolled.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Escourrou G, De Luca D. Lung ultrasound decreased radiation exposure in preterm infants in a neonatal intensive care unit. Acta Paediatr. 2016 May;105(5):e237-9. doi: 10.1111/apa.13369. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduced radiation exposure We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography. 18 months
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