Neurological Menfestions in Neonatal SepsisNCT07813689
Detection of Neurological Manifestations Among Neonates With Sepsis
An observational study of Neurological Menfestions in Neonatal Sepsis, run by Assiut University.
Trial summary
This observational prospective study aims to detect neurological menifestations in neonates with sepsis attending Assiut University Children Hospital Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neurological Menfestions in Neonatal Sepsis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU during the study period.
Who may be able to join
- Neonates aged 0-28 days ( both fullterm and preterm neonates).
- Diagnosed with neonatal sepsis.
- Admitted to the NICU during the study period.
Who cannot join
- Neonates with major congenital anomalies of the central nervous system.
- Neonates with hypoxic-ischemic encephalopathy.
- Neonates with confirmed inborn errors of metabolism.
- Neonates with chromosomal abnormalities.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This observational prospective study aims to detect neurological menifestations in neonates with sepsis attending Assiut University Children Hospital
Read the detailed description
Neonatal sepsis remains a major global health problem and a leading cause of neonatal morbidity and mortality. Globally, an estimated 1.3-3.9 million cases occur annually, resulting in approximately 400,000-700,000 deaths each year. It is a life-threatening systemic inflammatory response to bacterial, viral, or fungal infections occurring during the first 28 days of life and may progress to multiorgan dysfunction and death.
Neonatal sepsis is classified into early-onset sepsis (EOS), occurring within the first 72 hours and usually related to vertical maternal transmission, and late-onset sepsis (LOS), occurring after 72 hours up to 28 days and commonly associated with postnatal or hospital-acquired infections.
Neonates are particularly susceptible to sepsis because of immature immune and barrier defenses. Neonatal polymorphonuclear leukocytes have impaired chemotaxis, adherence, and bactericidal activity. Humoral immunity depends largely on maternally derived IgG transferred during the last trimester, making preterm infants especially vulnerable due to reduced transplacental transfer. Immature skin and mucosal barriers further facilitate microbial invasion.
Sepsis results from a dysregulated systemic inflammatory response following failure to control the invading pathogen. Excessive release of cytokines such as IL-6 and TNF-α, together with vasoactive mediators including nitric oxide, prostaglandins, and leukotrienes, causes endothelial dysfunction, vasodilation, increased vascular permeability, hypotension, impaired tissue perfusion, and potentially multiorgan dysfunction.
The developing neonatal brain is particularly vulnerable to these systemic effects. Inflammatory and vasoactive mediators can disrupt the blood-brain barrier, while cerebral circulatory disturbances, endothelial injury, neurotransmitter dysregulation, and oxidative stress may contribute to central nervous system (CNS) injury. In addition, blood-brain barrier dysfunction may facilitate pathogen entry into the CNS, increasing the risk of meningitis and cerebral dysfunction. Systemic inflammation may also cause white matter injury through oligodendrocyte damage and impaired cerebral perfusion, particularly in preterm infants.
Neurological manifestations of neonatal sepsis may include altered consciousness, seizures, abnormal tone and reflexes, apnea, and feeding difficulties with risk of aspiration. Cohort studies, particularly in preterm infants, have also demonstrated an increased risk of adverse long-term neurodevelopmental outcomes following neonatal sepsis.
- Keywords
- Neurological menifestions, Neonates, Sepsis
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of neurological manifestations among neonates with sepsis.
Measured: baseline
Secondary outcomes (3)
- Types of neurological manifestations among neonates with sepsis.
Measured: baseline
- Clinical charatericstics of septic neonates with and without neurological manifestations
Measured: baseline
- laboratory characteristics of septic neonates with and without neurological manifestations
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion5 Oct 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neurological Menfestions in 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Abd-Eltawab Hussein Ahmed, Assiut University
- Investigators
- Emad El-Deen Mahmoud Hammad El-daly, professor, Study chair, pediatrics Department, Assiut University HospitalsAmira Mohamed Shalaby, assistant professor, Study director, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813689
- Sponsor's protocol ID
- Neurolgy -Nonates-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hossain N, Rumman R, Alam MS, Jahan A, Mahmud R, Parajuli S, Shahidullah M, Mannan A. Detection of Neurological Complications by Cranial Ultrasound in Neonatal Sepsis: A Cross-sectional Study. J Pediatr Acad. 2024;5(4):116-122. doi:10.4274/jpea.2024.322.
World Health Organization. Global report on the epidemiology and burden of neonatal sepsis. Geneva: World Health Organization; 2024.
Kurul S, Beckers FLM, Vermeulen MJ, Suurland J, Hasbek JE, Ramakers CRB, Simons SHP, Reiss IKM, Taal HR. Inflammation, sepsis severity and neurodevelopmental outcomes of late-onset sepsis in preterm neonates. Pediatr Res. 2023 Dec;94(6):2026-2032. doi: 10.1038/s41390-023-02742-8. Epub 2023 Jul 19.
PubMed 37468719Schlapbach LJ, Aebischer M, Adams M, Natalucci G, Bonhoeffer J, Latzin P, Nelle M, Bucher HU, Latal B; Swiss Neonatal Network and Follow-Up Group. Impact of sepsis on neurodevelopmental outcome in a Swiss National Cohort of extremely premature infants. Pediatrics. 2011 Aug;128(2):e348-57. doi: 10.1542/peds.2010-3338. Epub 2011 Jul 18.
PubMed 21768312Dumbuya JS, Li S, Liang L, Zeng Q. Paediatric sepsis-associated encephalopathy (SAE): a comprehensive review. Mol Med. 2023 Feb 23;29(1):27. doi: 10.1186/s10020-023-00621-w.
PubMed 36823611Raturi A, Chandran S. Neonatal Sepsis: Aetiology, Pathophysiology, Diagnostic Advances and Management Strategies. Clin Med Insights Pediatr. 2024 Sep 25;18:11795565241281337. doi: 10.1177/11795565241281337. eCollection 2024.
PubMed 39371316Kariniotaki C, Thomou C, Gkentzi D, Panteris E, Dimitriou G, Hatzidaki E. Neonatal Sepsis: A Comprehensive Review. Antibiotics (Basel). 2024 Dec 25;14(1):6. doi: 10.3390/antibiotics14010006.
PubMed 39858292
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Neurological Manifestations Among Neonates With Sepsis
- ClinicalTrials.gov ID
- NCT07813689
- Acronym / sponsor ID
- Neurolgy -Nonates-Assiut-2026
- Keywords
- Neurological menifestions, Neonates, Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 5 Oct 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Sep 2026 (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 observational prospective study aims to detect neurological menifestations in neonates with sepsis attending Assiut University Children Hospital
Detailed description
Neonatal sepsis remains a major global health problem and a leading cause of neonatal morbidity and mortality. Globally, an estimated 1.3-3.9 million cases occur annually, resulting in approximately 400,000-700,000 deaths each year. It is a life-threatening systemic inflammatory response to bacterial, viral, or fungal infections occurring during the first 28 days of life and may progress to multiorgan dysfunction and death.
Neonatal sepsis is classified into early-onset sepsis (EOS), occurring within the first 72 hours and usually related to vertical maternal transmission, and late-onset sepsis (LOS), occurring after 72 hours up to 28 days and commonly associated with postnatal or hospital-acquired infections.
Neonates are particularly susceptible to sepsis because of immature immune and barrier defenses. Neonatal polymorphonuclear leukocytes have impaired chemotaxis, adherence, and bactericidal activity. Humoral immunity depends largely on maternally derived IgG transferred during the last trimester, making preterm infants especially vulnerable due to reduced transplacental transfer. Immature skin and mucosal barriers further facilitate microbial invasion.
Sepsis results from a dysregulated systemic inflammatory response following failure to control the invading pathogen. Excessive release of cytokines such as IL-6 and TNF-α, together with vasoactive mediators including nitric oxide, prostaglandins, and leukotrienes, causes endothelial dysfunction, vasodilation, increased vascular permeability, hypotension, impaired tissue perfusion, and potentially multiorgan dysfunction.
The developing neonatal brain is particularly vulnerable to these systemic effects. Inflammatory and vasoactive mediators can disrupt the blood-brain barrier, while cerebral circulatory disturbances, endothelial injury, neurotransmitter dysregulation, and oxidative stress may contribute to central nervous system (CNS) injury. In addition, blood-brain barrier dysfunction may facilitate pathogen entry into the CNS, increasing the risk of meningitis and cerebral dysfunction. Systemic inflammation may also cause white matter injury through oligodendrocyte damage and impaired cerebral perfusion, particularly in preterm infants.
Neurological manifestations of neonatal sepsis may include altered consciousness, seizures, abnormal tone and reflexes, apnea, and feeding difficulties with risk of aspiration. Cohort studies, particularly in preterm infants, have also demonstrated an increased risk of adverse long-term neurodevelopmental outcomes following neonatal sepsis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU | – | – |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU during the study period.
Key inclusion criteria (3 listed)
- Neonates aged 0-28 days ( both fullterm and preterm neonates).
- Diagnosed with neonatal sepsis.
- Admitted to the NICU during the study period.
Key exclusion criteria (4 listed)
- Neonates with major congenital anomalies of the central nervous system.
- Neonates with hypoxic-ischemic encephalopathy.
- Neonates with confirmed inborn errors of metabolism.
- Neonates with chromosomal 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
Detection of neurological manifestations among neonates with sepsis.
Time frame: baseline
3 secondary outcomes
- Types of neurological manifestations among neonates with sepsis.
Time frame: baseline
- Clinical charatericstics of septic neonates with and without neurological manifestations
Time frame: baseline
- laboratory characteristics of septic neonates with and without neurological manifestations
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- BackgroundHossain N, Rumman R, Alam MS, Jahan A, Mahmud R, Parajuli S, Shahidullah M, Mannan A. Detection of Neurological Complications by Cranial Ultrasound in Neonatal Sepsis: A Cross-sectional Study. J Pediatr Acad. 2024;5(4):116-122. doi:10.4274/jpea.2024.322.
- BackgroundWorld Health Organization. Global report on the epidemiology and burden of neonatal sepsis. Geneva: World Health Organization; 2024.
- Background: PubMed 37468719Kurul S, Beckers FLM, Vermeulen MJ, Suurland J, Hasbek JE, Ramakers CRB, Simons SHP, Reiss IKM, Taal HR. Inflammation, sepsis severity and neurodevelopmental outcomes of late-onset sepsis in preterm neonates. Pediatr Res. 2023 Dec;94(6):2026-2032. doi: 10.1038/s41390-023-02742-8. Epub 2023 Jul 19.
- Background: PubMed 21768312Schlapbach LJ, Aebischer M, Adams M, Natalucci G, Bonhoeffer J, Latzin P, Nelle M, Bucher HU, Latal B; Swiss Neonatal Network and Follow-Up Group. Impact of sepsis on neurodevelopmental outcome in a Swiss National Cohort of extremely premature infants. Pediatrics. 2011 Aug;128(2):e348-57. doi: 10.1542/peds.2010-3338. Epub 2011 Jul 18.
- Background: PubMed 36823611Dumbuya JS, Li S, Liang L, Zeng Q. Paediatric sepsis-associated encephalopathy (SAE): a comprehensive review. Mol Med. 2023 Feb 23;29(1):27. doi: 10.1186/s10020-023-00621-w.
- Background: PubMed 39371316Raturi A, Chandran S. Neonatal Sepsis: Aetiology, Pathophysiology, Diagnostic Advances and Management Strategies. Clin Med Insights Pediatr. 2024 Sep 25;18:11795565241281337. doi: 10.1177/11795565241281337. eCollection 2024.
- Background: PubMed 39858292Kariniotaki C, Thomou C, Gkentzi D, Panteris E, Dimitriou G, Hatzidaki E. Neonatal Sepsis: A Comprehensive Review. Antibiotics (Basel). 2024 Dec 25;14(1):6. doi: 10.3390/antibiotics14010006.
- Individual participant dataSharing planned: Undecided
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.
Emad El-Deen Mahmoud Hammad El-daly, professor study chair
pediatrics Department, Assiut University Hospitals
Amira Mohamed Shalaby, assistant professor study director
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Menfestions in 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal AbdEltawab Hussein, Resident (+201150832952, amal.18313308@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of neurological manifestations among neonates with sepsis. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813689, which also lists 7 linked publications.
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 11 Sep 2026.