Vitamin K deficiency bleeding
Conditions
Interventions
Exclusively Breastfed Control Group:Intramuscular injection of vitamin K1 injection
Exclusively Breastfed Test Group:Oral vitamin K1 drops, 1mg each time, once a week for a total of 12 weeks
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1.Healthy singleton newborns delivered via normal vaginal birth, with a gestational age =37 weeks and Apgar scores >= 8 at 1-5-10 minutes. 2.Mothers were healthy during pregnancy, with no history of special medication use, and did not take vitamin K, anticoagulants, or antiepileptic drugs during the prenatal, intrapartum, or postpartum periods (throughout the study). 3.Newborns who are planned to be exclusively breastfed for at least three months after birth. 4.Legal guardians are willing to comply with the medication schedule and follow-up visits, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Newborns allergic to any ingredient (active or excipient) of the vitamin K1 drops/vitamin K1 injection, or those with a history of hypersensitivity to two or more drugs (or foods). 2. Newborns unable to feed within 6 hours after birth. 3. Subjects whose mothers are currently taking warfarin. 4. Subjects whose mothers have used any medication known to interact with vitamin K within 4 weeks prior to screening. 5. Subjects whose mothers have a history of drug abuse within 1 year prior to screening. 6. Subjects for whom the investigator determines that any condition exists that may affect the subject's ability to provide informed consent or comply with the study protocol, or whose participation may compromise the study results or their own safety, or who are deemed otherwise unsuitable for clinical trial participation as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II); | — |
Secondary
| Measure | Time frame |
|---|---|
| Coagulation Function;Electrolytes;Coagulation Factor Activity;Vitamin K1 Plasma Concentration;Complete Blood Count (CBC);Liver and Kidney Function; | — |
Countries
China
Contacts
Public ContactLiuLi
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed