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Not yet recruitingNCT07813689Updated Sep 11, 2026

Detection of Neurological Manifestations Among Neonates With Sepsis

An observational study in Neurological Menfestions in Neonatal Sepsis, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
Up to 28 Days
Sex
All
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Study summary

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.

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Conditions studied

  • Neurological Menfestions in Neonatal Sepsis

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Keywords

  • Neurological menifestions
  • Neonates
  • Sepsis
03

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU during the study period.

Inclusion criteria

  • Neonates aged 0-28 days ( both fullterm and preterm neonates).
  • Diagnosed with neonatal sepsis.
  • Admitted to the NICU during the study period.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU
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What researchers measure

Primary outcomes

  1. Detection of neurological manifestations among neonates with sepsis.

    Time frame: baseline

Secondary outcomes

  1. - Types of neurological manifestations among neonates with sepsis.

    Time frame: baseline

  2. - Clinical charatericstics of septic neonates with and without neurological manifestations

    Time frame: baseline

  3. - laboratory characteristics of septic neonates with and without neurological manifestations

    Time frame: baseline

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Study locations

No study locations are listed for this record.

07

References and documents

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 37468719 ↗
  • Schlapbach 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 21768312 ↗
  • Dumbuya 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 36823611 ↗
  • Raturi 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 39371316 ↗
  • Kariniotaki 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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07813689
Lead sponsor
Assiut University
Responsible party
Amal Abd-Eltawab Hussein Ahmed (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 5, 2026 (estimated)
Primary completion
Oct 5, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Amal AbdEltawab Hussein, Resident
Contact
amal.18313308@med.aun.edu.eg
+201150832952
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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