NCT06626880

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2026

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 2, 2024

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    from 1/1/2025 to 1/1/2026.

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Neonates born to mothers with ITP.
  • Autoimmune thrombocytopenic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 20614393BACKGROUND
  • 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.

    PMID: 24563247BACKGROUND
  • 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.

    PMID: 32349778BACKGROUND
  • 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.

    PMID: 22157628BACKGROUND
  • 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.

    PMID: 12632021BACKGROUND
  • 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.

    PMID: 25520831BACKGROUND

MeSH Terms

Conditions

Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophilia

Study Officials

  • mohamed Hamdy Phd, Professor of hematology

    Professor of hematology of Pediatrics Faculty of Medicine - Assiut University

    STUDY CHAIR
  • Amira Shalaby Assistant professor

    Assistant professor of neonatology Faculty of Medicine - Assiut University

    STUDY CHAIR

Central Study Contacts

Mohamed mostafa Sleem, Resident Doctor of pediatric

CONTACT

Mohamed Hamdy Ghazaly

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor of pediatric

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 4, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 29, 2026

Last Updated

October 4, 2024

Record last verified: 2024-10