In preterm infants, regimens of prophylaxis vary widely in terms of dosage,route .The present study is intended to explore the vitamin k status by comparing efficacy of intravenous and intramuscular route by measuring PIVKA -II levels in preterm infants.

Methodology

Study design – Randomized control trial

Total Sample size with justification – 120

n1 – Vitamin K through IV, n2 – Vitamin K through IM

No. of groups - 2

Inclusion criteria

 Preterm infants >= 28 weeks

 Preterm infants < 33 weeks + 6 Days

Exclusion criteria

Fetal intracranial Hemorrhage (suspected on 18-30 weeks antenatal ultrasound scan].

H/O Alloimmune Thrombocytopenia

Maternal antiplatelet antibodies

Congenital abnormalities

Bruising at Birth

Subgaleal bleed

Mother on treatment with vitamin k antagonist, Heparin, warfarin

Study setting: Level 3 a NICU of a medical college

Parent of eligible infants will be counselled and informed consent will be obtained from parents. Babies will be randomized based on randomization sequence generated using computer generated random sequence. Allocation concealment will be achieved by using serially numbered opaque sealed envelopes (SNOSE). Vitamin K1 will be administered in NICU by intramuscular or intravenous route in an enclosed patient screen by a nursing staff handling allocation concealment not involved in the study.  Babies will be randomized to receive 1 mg (0.5ml) Vitamin K1 by Intravenous or Intramuscular route. 

Primary outcome

Protein induced by Vitamin K absence - II will be assessed at Day 5 and 30 

Secondary outcome (other complications of preterm babies)

 Intraventricular hemorrhage

 Necrotizing enterocolitis

 Late onset sepsis

 Bronchopulmonary dysplasia

 ROP requiring Laser

 Any bleeding manifestation in first 6 months of life