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to compare the efficacy of 1 mg and 2 mg vitamin K in preventing late vitamin K deficiency bleeding in young infants

Effect of one milligram versus two milligram intramuscular vitamin K to prevent late-onset hemorrhagic disease in young infants: A randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042625
Enrollment
82
Registered
2022-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

None listed

Interventions

Intervention1: 2mg Vitamin K: Routinely, vitamin K is given as 1 mg to all newborn at birth. In this study, 2mg vitamin K will be given one group and compared with another group receiving 1 mg Control

Sponsors

JIPMER Intramural Research Fund
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. PIVKA levels will be next measured in the child at 1 month of age. And PIVKA will be measured during 6 weeks immunisation.

Secondary

MeasureTime frame
Number of bleeding episodesTimepoint: 30 days 72 days

Countries

India

Contacts

Public ContactAmala Srilatha Natarajan

Jawaharlal Nehru Institute of Post graduate Medical Education and Research, Puducherry

dillikumar14@gmail.com9566028886

Outcome results

None listed

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