Viral InfectionNCT04519307
Evaluation of Newborns Presenting With Suspected COVID 19
An observational study of Viral Infection, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Viral Infection
- How many people
- 72 participants
- Where
- 1 siteTurkey (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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: All newborns who had respiratory symptoms at the NICU admission
Who may be able to join
- All newborns who had respiratory symptoms at the NICU admission
Who cannot join
- Congenital abnormalities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Dr. Behcet Uz Training and Research Hospital
Izmir
About this study
Official title: Evaluation of Newborns Presenting With Suspected COVID 19: A Single Center Experience
This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission
- Conditions
- Viral Infection
- Keywords
- newborn, covid infection, viral infection
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The newborns with covid 19 infection | |
| Group 2 | The newborns with no covid 19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Characteristics of the infants with respiratory infection at the NICU admission
Demographical characteristics will be recorded
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Mar 2020
- Primary completion1 Aug 2020
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Alkan Özdemir, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519307
- Sponsor's protocol ID
- 2020/251
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Newborns Presenting With Suspected COVID 19: A Single Center Experience
- ClinicalTrials.gov ID
- NCT04519307
- Acronym / sponsor ID
- 2020/251
- Conditions
- Viral Infection
- Keywords
- newborn, covid infection, viral infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –The newborns with covid 19 infection |
| Group 2 | – | –The newborns with no covid 19 infection |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All newborns who had respiratory symptoms at the NICU admission
Key inclusion criteria (1 listed)
- All newborns who had respiratory symptoms at the NICU admission
Key exclusion criteria (1 listed)
- Congenital abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General Characteristics of the infants with respiratory infection at the NICU admission
Time frame: 5 months
Demographical characteristics will be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Infection, run by Dr. Behcet Uz Children's Hospital at 1 site 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 19 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 1 site 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?
General Characteristics of the infants with respiratory infection at the NICU admission (time frame: 5 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 19 Aug 2020.