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Respiratory Syncytial Virus Infection May be More Dangerous in Neonate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531735
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Senem Alkan Özdemir, Dr. Behcet Uz Children's Hospital

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

Condition or disease
RSV Infection Covid19

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.

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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 : March 1, 2020
Actual Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
COVID positive infants
Group 2
RSV positive infants



Primary Outcome Measures :
  1. Oxygen status and evaluation of neonatal intensive care stay [ Time Frame: 3 months ]
    Total neonatal intensive care duration, total duration of oxygen supplement



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Newborns with respiratory symptoms
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Congenital abnormalities


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531735


Locations
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Turkey
Behçet Uz Children's Hospital
İzmirli, Izmir, Turkey, 35210
İzmir Dr. Behcet Uz Training and Research Hospital
İzmir, Turkey
Sponsors and Collaborators
Dr. Behcet Uz Children's Hospital
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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: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Senem Alkan Özdemir, Dr. Behcet Uz Children's Hospital:
newborn
covid infection
viral infection
RSV infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections