Skip to content

Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06626880
Enrollment
43
Registered
2024-10-04
Start date
2025-01-01
Completion date
2026-03-29
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated Intravascular Coagulation, Neonates

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of lifefrom 1/1/2025 to 1/1/2026.
whether DIC score could predict mortality in neonatesfrom 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.

Contacts

Primary ContactMohamed mostafa Sleem, Resident Doctor of pediatric
Mohamed.16266163@med.aun.edu.eg01558782966
Backup ContactMohamed Hamdy Ghazaly
mohamed.ghazali@med.aun.edu.eg01001296603

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026