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Not yet recruitingNCT06626880Updated Oct 4, 2024

Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

An observational study in Disseminated Intravascular Coagulation and Neonates, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
43
Ages
Up to 28 Days
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Disseminated Intravascular Coagulation
  • Neonates
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In context

Disseminated Intravascular Coagulation

38 studies on the registry are indexed under Disseminated Intravascular Coagulation; 8 are open to participants now.

This study's planned enrollment of 43 is below the median of 100 across 23 observational studies indexed under Disseminated Intravascular Coagulation.

Browse Disseminated Intravascular Coagulation studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
43 participants (estimated)
Patient registry
No
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What researchers measure

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

    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.

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 20614393 ↗
  • 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. PubMed 24563247 ↗
  • 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. PubMed 32349778 ↗
  • 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. PubMed 22157628 ↗
  • 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. PubMed 12632021 ↗
  • 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. PubMed 25520831 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06626880
Lead sponsor
Assiut University
Responsible party
Mohamed Mostafa Bakr Sleem (Resident Doctor of pediatric, Assiut University) — Principal investigator
First posted
Oct 4, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 29, 2026 (estimated)
Last update
Oct 4, 2024

Study contacts

Mohamed mostafa Sleem, Resident Doctor of pediatric
Contact
Mohamed.16266163@med.aun.edu.eg
01558782966 ext. +20
Mohamed Hamdy Ghazaly
Contact
mohamed.ghazali@med.aun.edu.eg
01001296603 ext. +20
mohamed Hamdy Phd, Professor of hematology
study chair · Professor of hematology of Pediatrics Faculty of Medicine - Assiut University
Amira Shalaby Assistant professor
study chair · Assistant professor of neonatology Faculty of Medicine - Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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