Viewing Study NCT06626880



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06626880
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-02

Brief Title: Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation
Sponsor: None
Organization: None

Study Overview

Official Title: Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 amp 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None