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Multicenter Real-World Study on Neonatal Umbilical Cord Blood Vitamin K1 Levels and Oral Vitamin K Administration for Prevention of Vitamin K Deficiency Bleeding

Multicenter Real-World Study on Neonatal Umbilical Cord Blood Vitamin K1 Levels and Oral Vitamin K Administration for Prevention of Vitamin K Deficiency Bleeding

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117790
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

vitamin K deficiency bleeding

Interventions

Oral Vitamin K1 Supplement Group:NA
No oral vitamin K1 supplementation group:NA

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.3 Years

Inclusion criteria

Inclusion criteria: (1) Newborns delivered at each center; (2) Complete case records (including maternal pregnancy history and newborn birth information); (3) Informed consent from legal guardians.

Exclusion criteria

Exclusion criteria: (1) Mothers with psychiatric disorders, autoimmune diseases, bleeding disorders, tuberculosis, unclear pregnancy history, or long-term use of psychiatric medications, anticoagulants, hormonal drugs, or anti-tuberculosis drugs; (2) Mothers with a history of transfusion of plasma, cryoprecipitate, or fibrinogen complex within one month prior to delivery; (3) Newborns with life-threatening congenital malformations; (4) The newborn has chromosomal/genetic disorders or inherited metabolic diseases; (5) The newborn has thrombocytopenia or coagulation abnormalities due to severe hemangiomas, immunodeficiency, or other conditions.

Design outcomes

Primary

MeasureTime frame
VitK1;

Secondary

MeasureTime frame
protein induced by vitamin K absence or antagonist-II;

Countries

China

Contacts

Public ContactHuifang Dong

The Third Affiliated Hospital of Zhengzhou University

sfydhf@163.com+86 155 1586 8022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026