NCT06204367

Brief 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, 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 2, 2024

Last Update Submit

January 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months

Secondary Outcomes (1)

  • lung radrology

    5 months

Interventions

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.

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

newborn

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University Faculty of Medicine

Kırıkkale, 71000, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 34600591BACKGROUND
  • Demont 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.

    PMID: 34340679BACKGROUND
  • American 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.

    PMID: 25070315BACKGROUND
  • Nair 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.

    PMID: 20399493BACKGROUND
  • Brat 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.

    PMID: 26237465BACKGROUND
  • Tandircioglu 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.

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsBronchiolitis

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBronchitisRespiratory Tract InfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Sevde Nur nu Vural, Asistant Dr

    KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Doctor

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations