Neonatal SEPSISPMCNSINICUPSNCT03308526
Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)
An observational study of Neonatal SEPSIS, run by Gehad Abdelnaser.
Trial summary
Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal SEPSIS
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Nov 2018
- How long will I take part?
- 12 Months
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates from age zero to 28 days
Who may be able to join
- both preterm and full term neonates
- both early onset and late onset neonatal sepsis
Who cannot join
- Genetic diseases immunocompromized neonates
- Neonates of diabetic mothers
- Neonates of HIV mothers
About this study
Official title: Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)
Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital.
Read the detailed description
Sepsis remains a leading cause of death in the intensive care units and in all age groups worldwide.sepsis was defined as the host's immune response(systemic inflammatory response syndrome) to injury and/or infectious stimuli in the presence of a known(or strongly suspected) infection .early onset neonatal sepsis occurs in utero or might become infected when exposed to potentially pathogenic bacteria,viruses,or fungi during passage through the birth canal.
- Conditions
- Neonatal SEPSIS
- Medical subject headings
- Neonatal Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of neonatal sepsis
Recognition of prevailing microorganisms causing neonatal sepsis in neonatal intensive care units to take preventive measures against it to decrease the incidence of neonatal sepsis
Measured: From september2017 to september 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SEPSISStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Gehad Abdelnaser
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Gehad Abdelnaser, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308526
- Sponsor's protocol ID
- AssiutUPedia51
- Acronym
- PMCNSINICUPS
- Status last verified
- Sep 2017
- First submitted
- 8 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)
- ClinicalTrials.gov ID
- NCT03308526
- Acronym / sponsor ID
- PMCNSINICUPS / AssiutUPedia51
- Conditions
- Neonatal SEPSIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gehad AbdelnaserUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 12 Oct 2017 (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.
Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital.
Detailed description
Sepsis remains a leading cause of death in the intensive care units and in all age groups worldwide.sepsis was defined as the host's immune response(systemic inflammatory response syndrome) to injury and/or infectious stimuli in the presence of a known(or strongly suspected) infection .early onset neonatal sepsis occurs in utero or might become infected when exposed to potentially pathogenic bacteria,viruses,or fungi during passage through the birth canal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates from age zero to 28 days
Key inclusion criteria (2 listed)
- both preterm and full term neonates
- both early onset and late onset neonatal sepsis
Key exclusion criteria (3 listed)
- Genetic diseases immunocompromized neonates
- Neonates of diabetic mothers
- Neonates of HIV mothers
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
Prevention of neonatal sepsis
Time frame: From september2017 to september 2018
Recognition of prevailing microorganisms causing neonatal sepsis in neonatal intensive care units to take preventive measures against it to decrease the incidence of neonatal sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS, run by Gehad Abdelnaser.
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 2 inclusion and 3 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevention of neonatal sepsis (time frame: From september2017 to september 2018). 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 12 Oct 2017.