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VITAMIN-K DEFICIENCY IN NEONATES

VITAMIN-K DEFICIENCY IN NEONATES ON PROLONGED (7DAYS) ANTIBIOTIC THERAPY IN NEONATAL INTENSIVE CARE UNIT:A PROSPECTIVE OBSERVATIONAL STUDY

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/053148
Enrollment
40
Registered
2023-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: D699- Hemorrhagic condition, unspecified

Interventions

None listed

Sponsors

INDIRA GANDHI INSTITUTE OF CHILD HEALTH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Neonates with gestational age of >28weeks,within 14 days of life. Should have received birth dose of vitamin-k. Received antibiotics for 7 days . Informed parental consent Willing for follow up till 4 weeks of age.

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformations or life threatening diseases. Neonatal cholestasis or any other medical conditions causing vitamin-k deficiency. Neonates on prolonged TPN, cholestasis etc receiving prophylactic vitamin-k. Neonates receiving vitamin-k antagonists. Neonates born to mother who have received or currently receiving vitamin-k antagonists ,anticonvulsants or anti-TB drugs. Neonates receiving anticonvulsants or anti-TB. Neonates with acute kidney injury (serum creatinine >1.5mg/dl).

Design outcomes

Primary

MeasureTime frame
To evaluate the proportion of neonates with biochemical vitamin-k deficiency after 7 days of antibiotic therapyTimepoint: To evaluate the proportion of neonates with biochemical vitamin-k deficiency after 7 days of antibiotic therapy.

Secondary

MeasureTime frame
To evaluate the proportion of neonates with biochemical vitamin-k deficiency after 4 weeks of last antibiotic dose. To evaluate the proportion of neonates with late HDN or clinically significant bleeding. Timepoint: 4 weeks

Countries

India

Contacts

Public ContactDr JAGATH

INDIRA GANDHI INSTITUTE OF CHILD HEALTH

Prathikbh@gmail.com9717235721

Outcome results

None listed

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