Health Condition 1: null- All neonates with symptomatic sepsis who are on antibiotics for 7 or more days are being enrolled
Conditions
Interventions
Intervention1: Vitamin K3(Injection Menadione): Vitamin K3 is a safe drug used in all newborns for prophylaxis at birth.
Dose: 1mg
Duration: Single dose
Route: Intramuscular
Total duration: Singla sta
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: a. All inborn neonates with symptomatic sepsis
Exclusion criteria
Exclusion criteria: a. Neonates with clinical bleeding b. Neonates who have received vitamin K within 3 days of start of antibiotic therapy (except the birth dose) c. Cholestasis with liver dysfunction d. Prenatally diagnosed bleeding disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To compare the effect of prophylactic versus no vitamin K administration at 7thday of antibiotic therapy on the prevalence of vitamin K deficiency (PIVKA levels 2ng/ml) in neonates at 14±2 days of starting antibiotic therapyTimepoint: Enrollment at 7 days Evaluation for PIVKA levels at 14 days of starting antibiotic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of prophylactic versus no vitamin K administration at 7th day of antibiotic therapy on the prevalence of coagulopathy in neonates at 14 ±2 days of starting antibiotic therapyTimepoint: Evaluation for PT/INR at 14 days of starting antibiotic therapy | — |
Countries
India
Contacts
Public ContactDr Ramesh Aggarwal
All India Institute of Medical Sciences
Outcome results
None listed