Detection of Neurological Manifestations Among Neonates With Sepsis
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Amal AbdEltawab Hussein, Resident
- 電話番号:+201150832952
- メール:amal.18313308@med.aun.edu.eg
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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The study will include neonates diagnosed with neonatal sepsis who are admitted to the NICU
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Detection of neurological manifestations among neonates with sepsis.
時間枠:baseline
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baseline
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二次結果の測定
結果測定 |
時間枠 |
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- Types of neurological manifestations among neonates with sepsis.
時間枠:baseline
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baseline
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- Clinical charatericstics of septic neonates with and without neurological manifestations
時間枠:baseline
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baseline
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- laboratory characteristics of septic neonates with and without neurological manifestations
時間枠:baseline
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baseline
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Emad El-Deen Mahmoud Hammad El-daly, professor、pediatrics Department, Assiut University Hospitals
- スタディディレクター:Amira Mohamed Shalaby, assistant professor、pediatrics Department, Assiut University Hospitals
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Neurolgy -Nonates-Assiut-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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