Role of vitamin K in neonates after antibiotic therapy
Not Applicable
- Conditions
- Health Condition 1: null- All neonates with symptomatic sepsis who are on antibiotics for 7 or more days are being enrolled
- Registration Number
- CTRI/2017/02/007776
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a.All inborn neonates with symptomatic sepsis
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>Evaluation for PIVKA levels at 14 days of starting antibiotic therapy
- Secondary Outcome Measures
Name Time Method 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