Neonatal SepsisNCT06113653
Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis
An observational study of Neonatal Sepsis, run by Assiut University.
Trial summary
A prospective cross-sectional study of outcomes and predictors of mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut University Children's Hospital Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Prospective study
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2023to 31 Mar 2025
- 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 1 minute to 28 days
- All sexes
- Child
Study population: All preterm infants diagnosed with neonatal sepsis
Who may be able to join
- All preterm infants (<37 weeks) diagnosed with neonatal sepsis
- Preterm infants aged 0-28 days
Who cannot join
- Full term infants (> 37 weeks gestation) -Neonates with congenital anomalies -Neonates diagnosed with metabolic diseases
- Neonates with birth asphyxia
About this study
Official title: Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis Admitted in NICU of Assiut University Children's Hospital
A prospective cross-sectional study of outcomes and predictors of mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut University Children's Hospital
Read the detailed description
Neonatal sepsis is a clinical syndrome of bacteremia with systemic signs and symptoms of infection in the first 28 days of life. It can also result from viral and fungal invasions of the bloodstream It is one of the events that can occur during neonatal intensive care unit (NICU) admission. It contributes significantly to the morbidity of very preterm (VP: <32 weeks gestational age) and/or very low birthweight (VLBW: <1500 g) infants Sepsis is a major cause of neonatal mortality and neurodevelopmental impairment among neonates which results in death and major disability for 39% of those affected even with timely antibiotic treatment .
Globally, it is estimated that more than 1.4 million neonatal deaths annually are the consequence of invasive infections .
Infection-specific mortality varies by geographic region and neonatal risk factors like gestational age and body weight .
It contributes to nearly 30-50% of neonatal deaths in developing countries . The risk of death is highest in the first 24 h of life when more than half of deaths occur and about three-quarters of all neonatal deaths occur within the first week of life.
- Conditions
- Neonatal Sepsis
- Being tested
- Prospective study
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective studyOther
Prospective study of outcomes and predictors of mortality among preterm infants with neonatal sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality among preterm infants with neonatal sepsis
mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut university children's hospital
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start28 Oct 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Thabet Ragab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113653
- Sponsor's protocol ID
- Outcomes of neonatal sepsis
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis Admitted in NICU of Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT06113653
- Acronym / sponsor ID
- Outcomes of neonatal sepsis
- Conditions
- Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Nov 2023 (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.
A prospective cross-sectional study of outcomes and predictors of mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut University Children's Hospital
Detailed description
Neonatal sepsis is a clinical syndrome of bacteremia with systemic signs and symptoms of infection in the first 28 days of life. It can also result from viral and fungal invasions of the bloodstream It is one of the events that can occur during neonatal intensive care unit (NICU) admission. It contributes significantly to the morbidity of very preterm (VP: <32 weeks gestational age) and/or very low birthweight (VLBW: <1500 g) infants Sepsis is a major cause of neonatal mortality and neurodevelopmental impairment among neonates which results in death and major disability for 39% of those affected even with timely antibiotic treatment .
Globally, it is estimated that more than 1.4 million neonatal deaths annually are the consequence of invasive infections .
Infection-specific mortality varies by geographic region and neonatal risk factors like gestational age and body weight .
It contributes to nearly 30-50% of neonatal deaths in developing countries . The risk of death is highest in the first 24 h of life when more than half of deaths occur and about three-quarters of all neonatal deaths occur within the first week of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- All preterm infants diagnosed with neonatal sepsis
Key inclusion criteria (2 listed)
- All preterm infants (<37 weeks) diagnosed with neonatal sepsis
- Preterm infants aged 0-28 days
Key exclusion criteria (2 listed)
- Full term infants (> 37 weeks gestation) -Neonates with congenital anomalies -Neonates diagnosed with metabolic diseases
- Neonates with birth asphyxia
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 |
|---|---|---|
| Prospective studyProspective study of outcomes and predictors of mortality among preterm infants with neonatal sepsis | Other | – |
Primary outcome
mortality among preterm infants with neonatal sepsis
Time frame: Baseline
mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut university children's hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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.
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 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 2 inclusion and 2 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 2 Nov 2023. 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?
mortality among preterm infants with neonatal sepsis (time frame: Baseline). 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 2 Nov 2023.