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Multicenter Randomized Controlled Prospective Clinical Study on Different Administration Methods of Vitamin K1 for the Prevention of Neonatal Hemorrhagic Disease in Preterm Infants <=35 Weeks of Gestation

Multicenter Randomized Controlled Prospective Clinical Study on Different Administration Methods of Vitamin K1 for the Prevention of Neonatal Hemorrhagic Disease in Preterm Infants <= 35 Weeks of Gestation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114451
Enrollment
Unknown
Registered
2025-12-11
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Hemorrhagic disease of the newborn

Interventions

Oral group:Orally administer vitamin K? at 2 mg per dose at birth (within 6 hours), 1 week, and 1 month, for a total of 3 doses.
IM group:At birth and at 1 month of age, intramuscular injection of VitK1 1 mg/dose × 2 doses

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Infants delivered in the obstetrics department of our institution. 2.Preterm infants with gestational age <=35 weeks; 3.Admitted to the neonatology department within 6 hours after birth;

Exclusion criteria

Exclusion criteria: 1.Patients with congenital coagulation factor deficiency; 2.Suspected fetal intracranial hemorrhage on routine prenatal ultrasound examination; 3.Maternal history of anti-platelet antibodies or alloimmune thrombocytopenia; 4.Maternal use of drugs known to affect vitamin K metabolism; 5.Severe congenital developmental abnormalities, suspected to involve gene mutations or genetic metabolic diseases; 6.Guardians do not consent to participate in this study;

Design outcomes

Primary

MeasureTime frame
Serum vitamin K1;Clinical bleeding manifestations;

Secondary

MeasureTime frame
Protein Induced by Vitamin K Absence (PIVKA);Coagulation function;Platelet count;

Countries

China

Contacts

Public ContactYue Shaojie

Xiangya Hospital Central South University

shaojieyue@163.com+86 731 89753044

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026