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An Audit Study on Management of Neonates With Neonatal Sepsis Admitted to Asyut University Children Hospital (ASMNWNSATAUC)

2018年8月15日 更新者:heba mostafa taher mostafa

The present study aims to evaluate management of neonates with neonatal sepsis admitted to the Neonatology Unit, Assiut University Children Hospital according to the guidelines of the American Academy of Pediatrics, 2018,[25] searching for defects, obstacles, or needs to improve the management of such cases.

We consider that this critical appraisal of our own performance, is a crucial step before any further corrections or developments of that performance could take place.

調査の概要

詳細な説明

Definition:

Neonatal sepsis is a systemic response to infection documented by positive blood culture in the first month of life. [1]

Classification:

It may be categorized as early-onset or late-onset.

Early-onset sepsis is associated with acquisition of microorganisms from the mother. Transplacental infection or an ascending infection from the cervix may be caused by organisms that colonize the mother's genitourinary (GU) tract; the neonate acquires the microorganisms as it passes through the colonized birth canal at delivery. Of newborns with early-onset sepsis, 85% present within 24 hours, 5% present at 24-48 hours, and a smaller percentage present within 48-72 hours. Onset is most rapid in premature neonates. [2]

Late-onset sepsis occurs after 3 days of life and is acquired from the caregiving environment.[3] Pathophysiology:[10] Neonates are particularly vulnerable to infection as a result of lower non-specific immunity (inflammation) and specific (humeral), such as low phagocytosis, chemotaxis response delay, minimal or absence of immunoglobulin A and immunoglobulin M (IgA and IgM), and low levels of complement.

Sepsis in the neonatal period can be obtained before birth through the placenta from the maternal blood stream or during labor for ingestion or aspiration of infected amniotic fluid.

Sepsis early (less than 3 days) obtained in the perinatal period, infection can occur from direct contact with the organism from the gastrointestinal or genitourinary tract maternal. The most frequent infecting organism is group B streptococcus (GBS) and Escherichia coli, which is present in the vagina. GBS emerged as a highly virulent microorganisms in the neonate, with a high mortality rate (50%) in infants exposed to Haemophilus influenzae and Staphylococcus negative coagulation are also often seen in early-onset sepsis in infants with very low birth weight.

Advanced Sepsis (1 to 3 weeks after birth) primarily nosocomial, and organisms that attack is usually staphylococci, Klebsiella, enterococcus and pseudomonas. Coagulation negative staphylococci, commonly found as the cause of septicemia in infants of low birth weight and very low birth weight. Bacterial invasion can occur through such Gated umbilical stump, skin, mucous membranes of eyes, nose, pharynx, and ear, and internal systems such as the respiratory system, nervous, urinary, and gastrointestinal.

Postnatal infection, derived from cross-contamination with other babies, personnel, or objects in the environment. Bacteria commonly found in water sources, a humidifier, sink pipes, suction machines, most equipment respiration, and arterial and venous catheters inserted used for infusion, blood sampling, monitoring of vital signs.

The process begins with the invasion of the pathophysiology of bacterial sepsis and systemic contamination. The release of endotoxin by bacteria cause changes in the function of the myocardium, changes in uptake and utilization of oxygen inhibition of mitochondrial function, and progressive metabolic chaos. In sepsis sudden and severe, complemen cascade caused much death and damage cells. The result is a decrease in tissue perfusion, metabolic acidosis, and shock, disseminated intravascular coagulation resulting (DIC) and death.[11]

Patients with immune disorders have an increased risk for serious nosocomial sepsis. Cardiopulmonary manifestations of gram-negative sepsis can be replicated by injection of endotoxin or Tumor Necrosis Factor (TNF). Barriers to employment TNF by anti-TNF monoclonal antibody greatly weakens manifestation of septic shock. When the bacterialcell wall components are released in the bloodstream, cytokine-activated, and can further lead to more physiological mess. Either alone or in combination, bacterial products and pro-inflammatory cytokines trigger a physiological response to stop the invaders (invader) microbes. TNF and other inflammatory mediators increase vascular permeability and vascular tone imbalance, and the imbalance between perfusion and increased metabolic needs of the network.[12]

Shock is defined as a systolic pressure below the 5th percentile for age or defined with cold extremities. Capillary refilling the late (more than 2 seconds) is seen as a reliable indicator of a decrease in peripheral perfusion. Peripheral vascular pressure in septic shock (heat) but be very up on a further shock (cold). In septic shock tissue oxygen consumption exceeds oxygen supply. This imbalance is caused by peripheral vasodilatation in the beginning, during further vasoconstriction, myocardial depression, hypotension, ventilator insufficiency, and anemia.[13]

Septicemia shows the emergence of a systemic infection of the blood caused by the rapid multiplication of microorganisms or toxic substances, which can cause huge psychological change. These substances can be pathogenic bacteria, fungi, viruses, and rickets. The most common cause of septicemia is a gram-negative organisms. If the protection of the body is not effective in controlling the invasion of microorganisms, septic shock may occur, which is characterized by hemodynamic changes, imbalance of cellular functions, and multiple system failures.

研究の種類

観察的

入学 (予想される)

40

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:mostafa T mostafa, father
  • 電話番号:+2001006320307

研究場所

    • Asyut
      • Asyūţ、Asyut、エジプト
        • 募集
        • Asyut University Children Hospital
        • コンタクト:
          • mostafa T mostafa, father
          • 電話番号:+2001006320307
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1日~4週間 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Medical records of neonates with neonatal sepsis admitted to the Neonatology Unit, Assiut University Children's Hospital during the period from the 1st of January, 2018 to the 31st of December, 2018. These records will be collected and reviewed to choose the cases which fulfilled the inclusion criteria of the study.

A structured data collection form will be designed to gather the clinical, laboratorial, imaging and therapeutic data from the included records. This form will be designed according to the published guidelines for neonatal sepsis by the American Academy of Pediatrics, 2018. [25] The data will be tabulated using Epi Info, version 16.0, and the results will be examined by Chi-square statistics. The magnitude of significant associations will be presented as p-value, Odds Ratios (OR), and 95% confidence interval for the OR. A p-value of less than 0.05 will be considered statistically significant.

説明

Inclusion Criteria:

  • 1. All neonates have risk factors of sepsis. 2. All neonates have manifestations of sepsis.

Exclusion Criteria:

  • 1. Infants aged more than 28 days.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:他の
  • 時間の展望:見込みのある

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
メジャーの説明
時間枠
Guidelines of management of Neonatal sepsis According to American Academy of Pediatrics
時間枠:one year
outcome of neonates with neonatal sepsis managed according to these guidlines
one year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:heba M taher, M. B. B. CH、Asyut University Children Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年6月1日

一次修了 (予想される)

2019年6月1日

研究の完了 (予想される)

2019年12月1日

試験登録日

最初に提出

2018年8月15日

QC基準を満たした最初の提出物

2018年8月15日

最初の投稿 (実際)

2018年8月17日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月17日

QC基準を満たした最後の更新が送信されました

2018年8月15日

最終確認日

2018年8月1日

詳しくは

本研究に関する用語

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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