Neonatal SEPSISNCT03354650
Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital
An observational study of Neonatal SEPSIS, run by Assiut University.
Trial summary
Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries. Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal SEPSIS
- What is being tested?
- blood culture
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jul 2019
- 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 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: All admitted male and female infant from the birth to the day 30 after birth
Who may be able to join
- All admitted inborn and out born neonates during this study period will be screened for sepsis
Who cannot join
- All cases that mimic neonatal sepsis such as;
- Inborn errors of metabolism
- Congestive heart failure
- Hemolytic Disease of Newborn
- Hypoxic ischemic encephalopathy
- Congenital Diaphragmatic Hernia
- Intra cranial hemorrhage
- Respiratory Distress Syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidemiology of Neonatal Sepsis in Infants Admitted to Neonatal Intensive Care Unit in Assiut University Children Hospital
Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.
Read the detailed description
More than 40% of under-five deaths globally occur in the neonatal period, resulting in 3.1 million newborn death each year.
The majority of these deaths usually occur in low income countries . On the other hand, the survivors of neonatal sepsis are vulnerable to short- and long term neurodevelopmental morbidity .
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life. It includes various systemic infections of the newborn such as septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and urinary tract infections. Superficial infections like conjunctivitis and oral thrush are usually not included under neonatal sepsis.
Diagnosis of sepsis in neonates is challenging due to nonspecific signs and symptoms. The salient clinical features include systemic signs of infection such as fever, hypothermia, tachycardia, failure to thrive, lethargy, irritability, restlessness In addition, laboratory diagnosis until recently was time-consuming. This, therefore, necessitates the initiation of empirical antibiotic therapy pending a definitive diagnosis .
Neonatal sepsis is caused by Gram-positive and Gram-negative bacteria and Candida. The diversity of organisms causing sepsis varies from region to another and changes over time even in the same place .
- Conditions
- Neonatal SEPSIS
- Being tested
- blood culture
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood cultureDiagnostic test
Also called other cultures if needed
blood culture to determine causative organisms of neonatal sepsis
| Study group | Role | What they receive |
|---|---|---|
| complete blood count | blood sample is collected from infant to detect presence of sepsis Receives: Diagnostic Test: blood culture | |
| c reactive protein | measuring c reactive protein in blood sample to determine neonatal sepsis Receives: Diagnostic Test: blood culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neonatal sepsis
by measuring the incidence of neonatal sepsis helping to know the size of the problem of neonatal sepsis
Measured: up to 4 months
prevalence of neonatal sepsis
by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly
Measured: up to 4 months
Secondary outcomes (1)
risk factors and causative organisms of neonatal sepsis
by determining the relation between risk factors and incidence of neonatal sepsis and by determining the causative organisms this help in prevention and management of neonatal sepsis
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jul 2019 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MSHAhmed, Assiut University
- Investigators
- Gehan Mo Kamal El_Din, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354650
- Sponsor's protocol ID
- EONI
- Status last verified
- Nov 2017
- First submitted
- 28 Oct 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Neonatal Sepsis in Infants Admitted to Neonatal Intensive Care Unit in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT03354650
- Acronym / sponsor ID
- EONI
- Conditions
- Neonatal SEPSIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 28 Nov 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.
Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.
Detailed description
More than 40% of under-five deaths globally occur in the neonatal period, resulting in 3.1 million newborn death each year.
The majority of these deaths usually occur in low income countries . On the other hand, the survivors of neonatal sepsis are vulnerable to short- and long term neurodevelopmental morbidity .
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life. It includes various systemic infections of the newborn such as septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and urinary tract infections. Superficial infections like conjunctivitis and oral thrush are usually not included under neonatal sepsis.
Diagnosis of sepsis in neonates is challenging due to nonspecific signs and symptoms. The salient clinical features include systemic signs of infection such as fever, hypothermia, tachycardia, failure to thrive, lethargy, irritability, restlessness In addition, laboratory diagnosis until recently was time-consuming. This, therefore, necessitates the initiation of empirical antibiotic therapy pending a definitive diagnosis .
Neonatal sepsis is caused by Gram-positive and Gram-negative bacteria and Candida. The diversity of organisms causing sepsis varies from region to another and changes over time even in the same place .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete blood count | – | Diagnostic Test: blood cultureblood sample is collected from infant to detect presence of sepsis |
| c reactive protein | – | Diagnostic Test: blood culturemeasuring c reactive protein in blood sample to determine neonatal sepsis |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All admitted male and female infant from the birth to the day 30 after birth
Key inclusion criteria (1 listed)
- All admitted inborn and out born neonates during this study period will be screened for sepsis
Key exclusion criteria (8 listed)
- All cases that mimic neonatal sepsis such as;
- Inborn errors of metabolism
- Congestive heart failure
- Hemolytic Disease of Newborn
- Hypoxic ischemic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood cultureAlso: other cultures if neededblood culture to determine causative organisms of neonatal sepsis | Diagnostic test | c reactive protein, complete blood count |
Primary outcome
Incidence of neonatal sepsis
Time frame: up to 4 months
by measuring the incidence of neonatal sepsis helping to know the size of the problem of neonatal sepsis
prevalence of neonatal sepsis
Time frame: up to 4 months
by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly
1 secondary outcome
risk factors and causative organisms of neonatal sepsis
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Neonatal SEPSIS
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
Chronic Granulomatous Disease, Infection
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
G-CSF In Neonatal Sepsis With Neutropenia
Neonatal Sepsis, Neutropenia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
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.
Gehan Mo Kamal El_Din, Professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS, run by Assiut University.
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 8 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 5 Dec 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?
Contact Ghan M Kamal El_Din, Professor (00201013706184 ext. Assiut, Gehankamal1958@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neonatal sepsis (time frame: up to 4 months). The study lists 2 primary outcomes in all. 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 5 Dec 2017.