Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

Not yet recruiting

• Conditions: Disseminated Intravascular Coagulation; Neonates

• Registration Number: NCT06626880
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

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

Exclusion Criteria

1. Neonates born to mothers with ITP.
2. Autoimmune thrombocytopenic patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life	from 1/1/2025 to 1/1/2026.
whether DIC score could predict mortality in neonates	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.