Respiratory Syncytial Virus Infection May be More Dangerous in Neonate
NCT ID: NCT04531735
Last Updated: 2020-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
28 participants
OBSERVATIONAL
2020-03-01
2020-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
COVID positive infants
No interventions assigned to this group
Group 2
RSV positive infants
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Days
1 Month
ALL
No
Sponsors
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Dr. Behcet Uz Children's Hospital
OTHER
Responsible Party
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Senem Alkan Özdemir
Associate Professor of Neonatology
Locations
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Behçet Uz Children's Hospital
İzmirli, İzmir, Turkey (Türkiye)
İzmir Dr. Behcet Uz Training and Research Hospital
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020/522
Identifier Type: -
Identifier Source: org_study_id
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