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Respiratory Syncytial Virus Infection May be More Dangerous in Neonate

Sponsor
Dr. Behcet Uz Children's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04531735
Collaborator
(none)
28
Enrollment
2
Locations
6
Anticipated Duration (Months)
14
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators aimed to compare clinical and radiographic markers between SARS-CoV-2 positive and RSV positive infants

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This single center cross-sectional study was conducted in University of Health Sciences Dr Behçet Uz Children's Hospital with a 400-bed tertiary care hospital in İzmir, Turkey, during the period of March 11 - April 30, 2020. This hospital is a pediatric referral center in the Aegean Region of Turkey with annual approximately 600,000 outpatients and 24,000 hospitalizations. All children with fever and cough who were tested by taken nasopharyngeal swabs for SARS-CoV2 and common human respiratory tract pathogens were included in the study.

    The clinician responsible for taking the respiratory samples were trained by the infection control committee on sampling and using personal protective equipment. Firstly, an oropharyngeal sampling was taken, and then a nasopharyngeal sampling was taken using the same swab from patient with fever and cough/shortness of breath for SARS-CoV-2 PCR. The same swab was used and placed in the same transport medium. The samples were sent to the laboratory determined by the Ministry of Health, following the cold chain rules. The protocol of Real Time-PCR was consistent with the recommendation of the WHO. Real time-PCR was performed at the local governmental centers for disease control and prevention. The kit wasapplied to nucleic acid isolates from nasopharyngeal aspirate/lavage, bronchoalveolar lavage, nasopharyngeal swab, oropharyngeal swab and sputum samples. Rapid diagnosis with the kit is achieved via one-step reverse transcription (RT) and real-time PCR (qPCR) (RT-qPCR) targeting SARS-CoV-2 (2019-nCoV)-specific RNA-dependent RNA polymerase (RdRp) gene fragment. The RdRp gene-targeted Wuhan-RdRp oligonucleotide set gives positive results only with SARS-CoV-2 (2019-nCoV)( Bio-Speedy®, Turkey SARS-CoV-2 (2019-nCoV) qPCR Detection Kit)

    Respiratory samples taken by nasopharyngeal swabs were tested for common human respiratory tract pathogens. For the testing of samples, real-time polymerase chain reaction (PCR) assay was performed. In the assay a commercial multiplex real-time PCR kit (Bosphore Respiratory Pathogens Panel Kit V4, Anatolia Geneworks, Turkey) was used to investigate the presence of Influenza viruses ( Influenza A, Pandemic H1N1 Influenza A, Seasonal H1N1 Influenza A and Influenza B), Parainfluenza (PIV) viruses (PIV-1, PIV-2, PIV-3 and PIV-4), Human Coronaviruses (HCoV) (CoV OC43, CoV NL63, CoV HKU1 and CoV 229E), Respiratory Syncytial Virus (RSV) A/B, Rhinovirus, Metapneumovirus, Enterovirus, Bocavirus, Adenovirus, Parechovirus and bacterial pathogens such as Mycoplasma pneumonia, Moraxella catarrhalis, Bordetella pertussis and Haemophilus influenzae type B in the clinical samples.

    Demographic, epidemiological and clinical data were obtained from hospital electronic information system medical records. For the statistical evaluation of the data, SPSS 20.0 Microsoft for Windows (IBM Corporation, Armonk, NY, USA). was used and P <0.05 value was considered statistically significant.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    28 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Is Respiratory Syncytial Virus Infection More Dangerous Than Covid 19 in the Neonatal Period?
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    Aug 1, 2020
    Anticipated Study Completion Date :
    Aug 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    COVID positive infants
    Group 2

    RSV positive infants

    Outcome Measures

    Primary Outcome Measures

    1. Oxygen status and evaluation of neonatal intensive care stay [3 months]

      Total neonatal intensive care duration, total duration of oxygen supplement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Days to 1 Month
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    During the study period respiratory symptoms at the NICU admission will be included

    Exclusion Criteria:

    Congenital abnormalities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Behçet Uz Children's Hospital İzmirli Izmir Turkey 35210
    2 İzmir Dr. Behcet Uz Training and Research Hospital İzmir Turkey

    Sponsors and Collaborators

    • Dr. Behcet Uz Children's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Senem Alkan Özdemir, Associate Professor of Neonatology, Dr. Behcet Uz Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04531735
    Other Study ID Numbers:
    • 2020/522
    First Posted:
    Aug 28, 2020
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Senem Alkan Özdemir, Associate Professor of Neonatology, Dr. Behcet Uz Children's Hospital
    newborn
    covid infection
    viral infection
    RSV infection
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    COVID-19
    Virus Diseases
    Respiratory Syncytial Virus Infections

    Study Results

    No Results Posted as of Aug 28, 2020