Newborn RdsLUDRENCT04722016
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE
An observational study of Newborn Rds and Transient Tachypnea of the Newborn, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Newborn Rds, Transient Tachypnea of the Newborn, Pneumonia
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Term or preterm neonates with respiratory distress that started within the first 24 h after birth
Who may be able to join
- 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.
Who cannot join
- Patients with a diagnosis of major malformations or chromosomal abnormalities, inherited metabolic diseases, congenital muscle disease-hypotonicity, hypoxic ischemic encephalopathy were not enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
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.
- Conditions
- Newborn Rds, Transient Tachypnea of the Newborn, Pneumonia
- Keywords
- lung ultrasonography, chest x ray, newborn
- Medical subject headings
- Pulmonary Atelectasis, Transient Tachypnea of the Newborn, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Newborn RdsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Tolga Çelik, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722016
- Sponsor's protocol ID
- GO-LUNG
- Acronym
- LUDRE
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26880491Tandircioglu 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.
PubMed 34687334
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE
- ClinicalTrials.gov ID
- NCT04722016
- Acronym / sponsor ID
- LUDRE / GO-LUNG
- Conditions
- Newborn Rds, Transient Tachypnea of the Newborn, Pneumonia
- Keywords
- lung ultrasonography, chest x ray, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term or preterm neonates with respiratory distress that started within the first 24 h after birth
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a diagnosis of major malformations or chromosomal abnormalities, inherited metabolic diseases, congenital muscle disease-hypotonicity, hypoxic ischemic encephalopathy were not enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduced radiation exposure
Time frame: 18 months
We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 26880491Escourrou 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.
- Derived from this study: PubMed 34687334Tandircioglu 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.
- lung ultrasonographyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Rds and Transient Tachypnea of the Newborn, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced radiation exposure (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.