LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE | NCT04722016

Studies
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE

NCT04722016

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Newborn Rds
Transient Tachypnea of the Newborn
Pneumonia

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Jan 20, 2021

First Submission Date that Met QC Criteria

Jan 21, 2021

First Posted Date

Jan 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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:

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Days

Standard Ages

Child

Study Population

Term or preterm neonates with respiratory distress that started within the first 24 h after birth

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara		06230	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26880491	Background	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. No abstract available.
34687334	Derived	Tandircioglu UA, Yigit S, Oguz B, Kayki G, Celik HT, Yurdakok M. Lung ultrasonography decreases radiation exposure in newborns with respiratory distress: a retrospective cohort study. Eur J Pediatr. 2022 Mar;181(3):1029-1035. doi: 10.1007/s00431-021-04296-5. Epub 2021 Oct 23.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012127	Respiratory Distress Syndrome, Newborn
D012128	Respiratory Distress Syndrome

ID	Term
D001261	Pulmonary Atelectasis
D059245	Transient Tachypnea of the Newborn
D011014	Pneumonia