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RSV InfectionNCT04531735

Respiratory Syncytial Virus Infection May be More Dangerous in Neonate

An observational study of RSV Infection and Covid19, run by Dr. Behcet Uz Children's Hospital at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigators aimed to compare clinical and radiographic markers between SARS-CoV-2 positive and RSV positive infants Read more about this study

Who is it for?
Ages 4 days to 1 month
Conditions the study is for
RSV Infection, Covid19
How many people
28 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Mar 2020to 31 Aug 2020
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 4 days to 1 month
  • All sexes
  • Child

Study population: Newborns with respiratory symptoms

Who may be able to join

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

Who cannot join

  • Congenital abnormalities

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • İzmir Dr. Behcet Uz Training and Research Hospital

    Izmir

  • Behçet Uz Children's Hospital

    İzmirli, İzmir, 35210

Other trials in Turkey (Türkiye)

About this study

Official title: Is Respiratory Syncytial Virus Infection More Dangerous Than Covid 19 in the Neonatal Period?

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

Read the 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.

Keywords
newborn, covid infection, viral infection, RSV infection
Medical subject headings
Respiratory Syncytial Virus Infections, COVID-19, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04531735
Study groupRoleWhat they receive
Group 1COVID positive infants
Group 2RSV positive infants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen status and evaluation of neonatal intensive care stay

    Total neonatal intensive care duration, total duration of oxygen supplement

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start1 Mar 2020
  3. Primary completion1 Aug 2020
  4. Study completion31 Aug 2020 (estimated)

Resources

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-control
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04531735
Sponsor's protocol ID
2020/522
Status last verified
Aug 2020
First submitted
19 Aug 2020
Last updated
28 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of RSV Infection and Covid19, run by Dr. Behcet Uz Children's Hospital at 2 sites 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 1 inclusion and 1 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Oxygen status and evaluation of neonatal intensive care stay (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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