NCT04722016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

January 20, 2021

Last Update Submit

January 22, 2021

Conditions

Keywords

lung ultrasonographychest x raynewborn

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

AgeUp to 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a diagnosis of major malformations or chromosomal abnormalities, inherited metabolic diseases, congenital muscle disease-hypotonicity, hypoxic ischemic encephalopathy were not enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26880491BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Pulmonary AtelectasisTransient Tachypnea of the NewbornPneumonia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory Distress Syndrome, NewbornRespiratory Distress SyndromeRespiration DisordersTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

January 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations