RSV InfectionNCT06204367
Evaluation of Lung Ultrasonography Findings in Newborns With Respiratory Syncytial Virus Bronchiolitis
An observational study of RSV Infection and Bronchiolitis, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Respiratory Syncytial Virus (RSV) is a seasonal, highly contagious pathogen belonging to the Pneumoviridae (genus orthopneumovirus), a family of negative-strand RNA viruses. Lung ultrasonography; Today, it has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless… Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- RSV Infection, Bronchiolitis
- What is being tested?
- Lung Ultrasonografisi
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 May 2024
- How long will I take part?
- 5 Months
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Study population: newborn
Who may be able to join
- All newborns hospitalized with viral lower respiratory tract findings in the neonatal intensive care unit of Kırıkkale University Faculty of Medicine Hospital
- Patients with study approval
- Patients who underwent lung ultrasonography were included in the study.
Who cannot join
- Newborns who do not lie down due to viral lower respiratory tract infection
- Patients without study consent
- Patients for whom lung ultrasonography could not be performed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Faculty of Medicine
Kirikkale, 71000
About this study
Respiratory Syncytial Virus (RSV) is a seasonal, highly contagious pathogen belonging to the Pneumoviridae (genus orthopneumovirus), a family of negative-strand RNA viruses. Lung ultrasonography; Today, it has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors, which are frequently encountered.
Read the detailed description
Respiratory Syncytial Virus (RSV) is a type of negative-strand RNA viruses. It is a seasonal, highly contagious pathogen belonging to the family Pneumoviridae (genus orthopneumovirus). RSV is a common cause of respiratory disease throughout life but is associated with significant morbidity and mortality, especially in infants and older adults.
RSV infections account for approximately 60% to 80% of bronchiolitis in infancy and 40% of pediatric pneumonias.
Bronchiolitis is an acute lower respiratory tract infection that affects children under one or two years of age and is the most common cause of hospitalization, according to American Academy of Pediatrics (AAP) guidelines. Diagnostic criteria for bronchiolitis are based on clinical history and examination.
Lung ultrasonography (LUS) was first used in adults in 1995, and in the last decade, lung ultrasound has proven to be a useful diagnostic tool in many pediatric and neonatal diseases, and its application and benefit in the treatment of bronchiolitis has been reported. Since AUS allows bedside assessment of the subpleural lung for density, thus reducing the quantitative ratio of airspace and space, it is reasonable to expect that a combination of clinical and ultrasound parameters may be useful. Studies have shown that qualitative and quantitative lung ultrasound findings suggest a relationship with the severity of bronchiolitis and are useful in the follow-up of patients.
Caiulo et al. They showed that AUS is a valuable tool in the diagnosis of bronchiolitis.
However, data on lung ultrasound in newborns with viral lower respiratory tract infections are quite limited.
Lung ultrasonography; Today, it has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. In our clinic, lung ultrasonography is performed on babies hospitalized with respiratory distress. Images will be obtained using the linear probe of the device to be used for AUS. Brat et al. AUS scoring specified in the studies of Raimondi et al. and Raimondi et al. will be used.
Accordingly, both lungs will be evaluated as three areas on the right and left (anterior upper, anterior lower and lateral) and will be scored separately. Parasternal with anterior axillary line in front The area between the line is divided into two by the line passing from the nipple. The upper part is considered as the upper anterior region and the lower part is considered as the lower anterior region. The area in the middle of the anterior and posterior axillary lines is called the lateral region.
is evaluated. Each field is given a score of 0 to 3. If there were A lines, 0 points were given. If there were more than 3 B lines in an area, 1 point was given. If the B lines were very dense and there was no A line, it was evaluated as white lung and 2 points were given. If there was a consolidation image in AUS, 3 points were given. The total score was evaluated as a maximum of 18. In this study, newborn babies who were admitted and admitted to the Neonatal Intensive Care Unit of Kırıkkale University Faculty of Medicine Hospital with symptoms of viral lower respiratory tract diseases between 18/12/2023 and 01/06/2023 were clinically diagnosed with 40% of their O2 need at the 24th hour of hospitalization. Lung ultrasonography was planned to be performed in cases where the patient was overweight and/or required pressure or was intubated, and at the time of discharge. Demographic characteristics, symptoms, all routine laboratory and radiological imaging of newborn babies, and additional pathogen or pathogens will be obtained from the file information. The parameters to be recorded are shown in the Case Report Form. The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors, which are frequently encountered.
- Conditions
- RSV Infection, Bronchiolitis
- Being tested
- Lung Ultrasonografisi
- Medical subject headings
- Respiratory Syncytial Virus Infections, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasonografisiDiagnostic test
It is aimed to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by frequently encountered RSV and other viral factors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasonography
It is aimed to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by frequently encountered RSV and other viral factors.
Measured: 5 months
Secondary outcomes (1)
lung radrology
The aim of using lung ultrasound in the clinical follow-up of newborn babies diagnosed with bronchiolitis caused by respiratory viral factors is to reduce the number of lung films and therefore reduce radiation exposure.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Dec 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevde Nur Vural, Kırıkkale University
- Investigators
- Sevde Nur nu Vural, Asistant Dr, Study chair, KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204367
- Sponsor's protocol ID
- Kırıkkale Neonatology
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Azzari C, Baraldi E, Bonanni P, Bozzola E, Coscia A, Lanari M, Manzoni P, Mazzone T, Sandri F, Checcucci Lisi G, Parisi S, Piacentini G, Mosca F. Epidemiology and prevention of respiratory syncytial virus infections in children in Italy. Ital J Pediatr. 2021 Oct 2;47(1):198. doi: 10.1186/s13052-021-01148-8.
PubMed 34600591Demont C, Petrica N, Bardoulat I, Duret S, Watier L, Chosidow A, Lorrot M, Kieffer A, Lemaitre M. Economic and disease burden of RSV-associated hospitalizations in young children in France, from 2010 through 2018. BMC Infect Dis. 2021 Aug 2;21(1):730. doi: 10.1186/s12879-021-06399-8.
PubMed 34340679American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014 Aug;134(2):415-20. doi: 10.1542/peds.2014-1665.
PubMed 25070315Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
PubMed 20399493Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
PubMed 26237465Tandircioglu UA, Koral U, Menemen SN, Alan S. Comparison of clinical findings and lung ultrasound scores in newborns with RSV and non-RSV viral lower respiratory tract infections: a prospective observational study. Eur J Pediatr. 2025 Dec 11;185(1):6. doi: 10.1007/s00431-025-06687-4.
PubMed 41379208
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Ultrasonography Findings in Newborns With Respiratory Syncytial Virus Bronchiolitis
- ClinicalTrials.gov ID
- NCT06204367
- Acronym / sponsor ID
- Kırıkkale Neonatology
- Conditions
- RSV Infection, Bronchiolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
Respiratory Syncytial Virus (RSV) is a seasonal, highly contagious pathogen belonging to the Pneumoviridae (genus orthopneumovirus), a family of negative-strand RNA viruses. Lung ultrasonography; Today, it has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors, which are frequently encountered.
Detailed description
Respiratory Syncytial Virus (RSV) is a type of negative-strand RNA viruses. It is a seasonal, highly contagious pathogen belonging to the family Pneumoviridae (genus orthopneumovirus). RSV is a common cause of respiratory disease throughout life but is associated with significant morbidity and mortality, especially in infants and older adults.
RSV infections account for approximately 60% to 80% of bronchiolitis in infancy and 40% of pediatric pneumonias.
Bronchiolitis is an acute lower respiratory tract infection that affects children under one or two years of age and is the most common cause of hospitalization, according to American Academy of Pediatrics (AAP) guidelines. Diagnostic criteria for bronchiolitis are based on clinical history and examination.
Lung ultrasonography (LUS) was first used in adults in 1995, and in the last decade, lung ultrasound has proven to be a useful diagnostic tool in many pediatric and neonatal diseases, and its application and benefit in the treatment of bronchiolitis has been reported. Since AUS allows bedside assessment of the subpleural lung for density, thus reducing the quantitative ratio of airspace and space, it is reasonable to expect that a combination of clinical and ultrasound parameters may be useful. Studies have shown that qualitative and quantitative lung ultrasound findings suggest a relationship with the severity of bronchiolitis and are useful in the follow-up of patients.
Caiulo et al. They showed that AUS is a valuable tool in the diagnosis of bronchiolitis.
However, data on lung ultrasound in newborns with viral lower respiratory tract infections are quite limited.
Lung ultrasonography; Today, it has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. In our clinic, lung ultrasonography is performed on babies hospitalized with respiratory distress. Images will be obtained using the linear probe of the device to be used for AUS. Brat et al. AUS scoring specified in the studies of Raimondi et al. and Raimondi et al. will be used.
Accordingly, both lungs will be evaluated as three areas on the right and left (anterior upper, anterior lower and lateral) and will be scored separately. Parasternal with anterior axillary line in front The area between the line is divided into two by the line passing from the nipple. The upper part is considered as the upper anterior region and the lower part is considered as the lower anterior region. The area in the middle of the anterior and posterior axillary lines is called the lateral region.
is evaluated. Each field is given a score of 0 to 3. If there were A lines, 0 points were given. If there were more than 3 B lines in an area, 1 point was given. If the B lines were very dense and there was no A line, it was evaluated as white lung and 2 points were given. If there was a consolidation image in AUS, 3 points were given. The total score was evaluated as a maximum of 18. In this study, newborn babies who were admitted and admitted to the Neonatal Intensive Care Unit of Kırıkkale University Faculty of Medicine Hospital with symptoms of viral lower respiratory tract diseases between 18/12/2023 and 01/06/2023 were clinically diagnosed with 40% of their O2 need at the 24th hour of hospitalization. Lung ultrasonography was planned to be performed in cases where the patient was overweight and/or required pressure or was intubated, and at the time of discharge. Demographic characteristics, symptoms, all routine laboratory and radiological imaging of newborn babies, and additional pathogen or pathogens will be obtained from the file information. The parameters to be recorded are shown in the Case Report Form. The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors, which are frequently encountered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborn
Key inclusion criteria (3 listed)
- All newborns hospitalized with viral lower respiratory tract findings in the neonatal intensive care unit of Kırıkkale University Faculty of Medicine Hospital
- Patients with study approval
- Patients who underwent lung ultrasonography were included in the study.
Key exclusion criteria (3 listed)
- Newborns who do not lie down due to viral lower respiratory tract infection
- Patients without study consent
- Patients for whom lung ultrasonography could not be performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasonografisiIt is aimed to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by frequently encountered RSV and other viral factors. | Diagnostic test | – |
Primary outcome
Lung ultrasonography
Time frame: 5 months
It is aimed to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by frequently encountered RSV and other viral factors.
1 secondary outcome
lung radrology
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 34600591Azzari C, Baraldi E, Bonanni P, Bozzola E, Coscia A, Lanari M, Manzoni P, Mazzone T, Sandri F, Checcucci Lisi G, Parisi S, Piacentini G, Mosca F. Epidemiology and prevention of respiratory syncytial virus infections in children in Italy. Ital J Pediatr. 2021 Oct 2;47(1):198. doi: 10.1186/s13052-021-01148-8.
- Background: PubMed 34340679Demont C, Petrica N, Bardoulat I, Duret S, Watier L, Chosidow A, Lorrot M, Kieffer A, Lemaitre M. Economic and disease burden of RSV-associated hospitalizations in young children in France, from 2010 through 2018. BMC Infect Dis. 2021 Aug 2;21(1):730. doi: 10.1186/s12879-021-06399-8.
- Background: PubMed 25070315American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014 Aug;134(2):415-20. doi: 10.1542/peds.2014-1665.
- Background: PubMed 20399493Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
- Background: PubMed 26237465Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
- Derived from this study: PubMed 41379208Tandircioglu UA, Koral U, Menemen SN, Alan S. Comparison of clinical findings and lung ultrasound scores in newborns with RSV and non-RSV viral lower respiratory tract infections: a prospective observational study. Eur J Pediatr. 2025 Dec 11;185(1):6. doi: 10.1007/s00431-025-06687-4.
- Individual participant dataSharing planned: Undecided
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RSV
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.
Sevde Nur nu Vural, Asistant Dr study chair
KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE
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 RSV Infection and Bronchiolitis, run by Kırıkkale 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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?
Results are not available in the source record.
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?
Lung ultrasonography (time frame: 5 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 NCT06204367, which also lists 6 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 12 Jan 2024.