to compare the efficacy of 1 mg and 2 mg vitamin K in preventing late vitamin K deficiency bleeding in young infants
Phase 2
Completed
- Registration Number
- CTRI/2022/05/042625
- Lead Sponsor
- JIPMER Intramural Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
Term neonates with appropriate for gestational age between 37 weeks to 42 weeks born by spontaneous vaginal delivery with normal Apgar scores ( >8/10 at 1 min).
Exclusion Criteria
Mother taking antiepileptics, anti-tubercular drugs and warfarin
Mother received vitamin K within one week of delivery.
Bleeding disorder in the family members (mother or sibling or father) and any first-degree relatives.
Suspected case of bleeding disorder in the neonate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subclinical vitamin deficiency (as measured by elevated PIVKA II level) will be lower in neonates who received 2mg vitamin K compared to neonates who received 1 mg at end of 1 month.Timepoint: PIVKA levels will be measured at birth from cord blood. <br/ ><br>PIVKA levels will be next measured in the child at 1 month of age. <br/ ><br>And PIVKA will be measured during 6 weeks immunisation.
- Secondary Outcome Measures
Name Time Method umber of bleeding episodesTimepoint: 30 days <br/ ><br>72 days