Clinical trial NCT06626880: Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation
Official title: Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Disseminated Intravascular Coagulation
Neonates
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 43
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted on neonates diagnosed as DIC based on their clinical and laboratory data. They will be recruited from NICU at Assiut University Children's Hospital from 1/1/2025 to 1/1/2026.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life
timeFrame: from 1/1/2025 to 1/1/2026.
measure: whether DIC score could predict mortality in neonates
timeFrame: from 1/1/2025 to 1/1/2026.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of hematology of Pediatrics Faculty of Medicine - Assiut University
name: mohamed Hamdy Phd, Professor of hematology
role: STUDY_CHAIR
affiliation: Assistant professor of neonatology Faculty of Medicine - Assiut University
name: Amira Shalaby Assistant professor
role: STUDY_CHAIR
References:
citation: Veldman A, Fischer D, Nold MF, Wong FY. Disseminated intravascular coagulation in term and preterm neonates. Semin Thromb Hemost. 2010 Jun;36(4):419-28. doi: 10.1055/s-0030-1254050. Epub 2010 Jul 7.
citation: Shirahata A, Mimuro J, Takahashi H, Tsuji H, Kitajima I, Matsushita T, Eguchi Y, Kitamura N, Honda G, Sakata Y. Postmarketing Surveillance of Recombinant Human Soluble Thrombomodulin (Thrombomodulin alpha) in Pediatric Patients With Disseminated Intravascular Coagulation. Clin Appl Thromb Hemost. 2014 Jul;20(5):465-72. doi: 10.1177/1076029614523490. Epub 2014 Feb 20.
citation: Go H, Ohto H, Nollet KE, Kashiwabara N, Ogasawara K, Chishiki M, Hiruta S, Sakuma I, Kawasaki Y, Hosoya M. Risk factors and treatments for disseminated intravascular coagulation in neonates. Ital J Pediatr. 2020 Apr 29;46(1):54. doi: 10.1186/s13052-020-0815-7.
citation: Poralla C, Traut C, Hertfelder HJ, Oldenburg J, Bartmann P, Heep A. The coagulation system of extremely preterm infants: influence of perinatal risk factors on coagulation. J Perinatol. 2012 Nov;32(11):869-73. doi: 10.1038/jp.2011.182. Epub 2011 Dec 8.
citation: Tay SP, Cheong SK, Boo NY. Circulating tissue factor, tissue factor pathway inhibitor and D-dimer in umbilical cord blood of normal term neonates and adult plasma. Blood Coagul Fibrinolysis. 2003 Feb;14(2):125-9. doi: 10.1097/00001721-200302000-00002.
citation: Wada H, Matsumoto T, Yamashita Y. Diagnosis and treatment of disseminated intravascular coagulation (DIC) according to four DIC guidelines. J Intensive Care. 2014 Feb 20;2(1):15. doi: 10.1186/2052-0492-2-15. eCollection 2014.