vitamin K deficiency bleeding
Conditions
Interventions
Oral Vitamin K1 with exclusive breastfeeding:Initial dose: Administer oral Vitamin K1 within 6 hours of birth, with the dosage determined by birth weight.
Birth weight >=1500g: 2mg
Birth weight =1500g
Sponsors
Nanjing Women and Children's Healthcare Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Live-born infants with a gestational age at birth of 28 weeks or more but less than 37 weeks; 2.The mother was healthy during pregnancy, had no history of special medication use, and did not use anti-tuberculosis drugs, coumarin anticoagulants, or enzyme-inducing antiepileptic drugs before, during, or after delivery (during the study period); 3.The guardians of the premature infants consented to participate in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Premature infants who are not eligible for oral supplementation with VitK1 preparations; 2. Premature infants prenatally diagnosed with severe congenital malformations and intracranial hemorrhage; 3. Premature infants who died or whose treatment was discontinued within 7 days after birth; 4. Premature infants whose mothers have a tendency to thrombosis or platelet disorders and are receiving treatment with known vitamin K antagonist drugs; 5. Subjects whose mothers have a history of drug abuse within the year prior to screening; 6. Premature infants diagnosed with congenital biliary atresia, cholestasis, hepatitis syndrome, persistent, or chronic diarrhea; 7.Any situation that the investigator believes may affect the subject's ability to provide informed consent or comply with the study protocol, or where participation may affect study outcomes or the subject's safety, or any other situation that the investigator considers unsuitable for participation in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma PIVKA-II level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PIVKA-II level;The rate of PIVKA-II turning negative in baseline PIVKA-II-positive subjects at 4 weeks and 12 weeks postnatal age;Plasma Vitamin K1 Level;Coagulation factor II, VII, IX and X activity, coagulation function and platelet count;Incidence of hemorrhagic diseases (including intracranial hemorrhage confirmed by imaging with abnormal neurological signs such as vomiting and lethargy, gastrointestinal bleeding, umbilical bleeding, skin bruises, and petechiae, etc.); | — |
Countries
China
Contacts
Public ContactShuping Han
Nanjing Women and Children's Healthcare Hospital
Outcome results
None listed