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NCT Number: NCT06626880

Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life, and whether DIC score could predict mortality in neonates.

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Key information

About this study

Disseminated intravascular coagulation (DIC) is a syndrome caused by the activation of blood coagulation, in which systemic intravascular micro thromboses result in multiple organ failure and severe bleeding due to consumption of platelets and coagulation factors [1]. Compared with adults, neonates have an immature coagulation-fibrinolysis system and are prone to complications that cause DIC, such as hypoxia, acidosis, and infection [2]. Additionally, preterm infants have a lower hemostatic profile than term infants, which increases their risk of DIC [3]. However, gold standard interventions and treatments for DIC are lacking in neonatal medicine, Veldman et al. suggested that DIC in neonates is caused by prenatal risk factors such as placental abruption (PA), pregnancy induced hypertension (PIH), and neonatal factors such as sepsis, asphyxia, and interventricular hemorrhage (IVH), along with postnatal factors, such as necrotizing enterocolitis, gastrointestinal perforation, and infection [4]. The Japan Society of Obstetrical, Gynecological & Neonatal Hematology (JSOGNH) revised its diagnostic guidelines for neonatal DIC in 2016 and proposed a DIC scoring system [5]. Anticoagulant therapy, such as antithrombin administration and fresh frozen plasma (FFP), has been used to treat neonatal DIC [6]. Since 2008, recombinant human soluble thrombomodulin (rTM) has emerged as a novel anticoagulant for DIC in Japan [7]. Reversal of the underlying condition is paramount in achieving treatment success in the newborn with DIC. Strategies such as early antibiotic therapy and identification and control of the source of disease in cases of necrotizing enterocolitis, sepsis, and septic shock should always precede interventions directed at normalizing the coagulation system [8]. reports are lacking about diseases associated with neonatal DIC and whether anything predicts mortality in this context. We discuss the clinical andlaboratory criteria using (JSOGNH) scoring system to see if DIC score could predict mortality in neonates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age at enrollment from the first day of life to 28 days of life.
  • Neonates diagnosed as DIC.

Exclusion criteria

  • Neonates born to mothers with ITP.
  • Autoimmune thrombocytopenic patients.

Treatment and study plan

Primary outcomes

  1. The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life

    Time frame: from 1/1/2025 to 1/1/2026.

  2. whether DIC score could predict mortality in neonates

    Time frame: from 1/1/2025 to 1/1/2026.

    The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life, and whether DIC score could predict mortality in neonates.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Hamdy Ghazaly

CONTACT

[email protected]

01001296603 ext. +20

Mohamed mostafa Sleem, Resident Doctor of pediatric

CONTACT

[email protected]

01558782966 ext. +20

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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