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Vitamin K injection protection by muscular vs venous delivery in preterm infants

Efficacy of Vitamin K prophyaxis in preterm infants intramuscular versus intravenous route: A Randomized Control Trial - VIKP-IMIV

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064903
Enrollment
120
Registered
2024-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Injection Vitamin K1: Single dose prophylaxis Intravenous 1 mg in babies weighing more than or equal to 1 kg Intravenous 0.5 mg in babies weighing less than 1 kg Control Intervention1:

Sponsors

Divya A
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants between 28 0/7 weeks to 33 6/7 weeks

Exclusion criteria

Exclusion criteria: Fetal intracranial Hemorrhage History of Alloimmune Thrombocytopenia Maternal antiplatelet antibodies Major Congenital abnormalities such as congential diaphragmatic hernia, anorectal malformation, VACTERL association, intestinal atresia Bruised at Birth Large Subgaleal bleed Mother on treatment with vitamin k antagonist, Heparin, warfarin APGAR BELOW 3 at 1 minute of life

Design outcomes

Primary

MeasureTime frame
Protein induced by vitamin K absence-II levels in bloodTimepoint: Day 5 and Day 30

Secondary

MeasureTime frame
Any bleeding manifestationsTimepoint: till 6 months of life;Bronchopulmonary dysplasiaTimepoint: till hospital stay;Intraventricular hemorrhageTimepoint: till 44 weeks post menstrual age;late onset sepsisTimepoint: till hospital stay;Nectrotising enterocolitisTimepoint: till hospital stay;Retinopathy of prematurityTimepoint: till 44 weeks post menstrual age

Countries

India

Contacts

Public ContactSubash S

SRM Medical College Hospital and Research Centre

ashokc3681@gmail.com9940076527

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026