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- Ensayo clínico NCT07813689
Detection of Neurological Manifestations Among Neonates With Sepsis
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amal AbdEltawab Hussein, Resident
- Número de teléfono: +201150832952
- Correo electrónico: amal.18313308@med.aun.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Detection of neurological manifestations among neonates with sepsis.
Periodo de tiempo: baseline
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baseline
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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- Types of neurological manifestations among neonates with sepsis.
Periodo de tiempo: baseline
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baseline
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- Clinical charatericstics of septic neonates with and without neurological manifestations
Periodo de tiempo: baseline
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baseline
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- laboratory characteristics of septic neonates with and without neurological manifestations
Periodo de tiempo: baseline
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baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Emad El-Deen Mahmoud Hammad El-daly, professor, pediatrics Department, Assiut University Hospitals
- Director de estudio: Amira Mohamed Shalaby, assistant professor, pediatrics Department, Assiut University Hospitals
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Neurolgy -Nonates-Assiut-2026
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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