A RANDOMISED CONTROLLED TRIAL COMPARING VITAMIN K STATUS INLESS THAN 32WEEKS AND OR LESS THAN 1500GMS AFTER 3 PROPHYLACTIC DOSAGE REGIMENS (0.3VS 0.5 MG VS 1MG IM) AT BIRTH

Informed written consent will be obtained beforehand, in case of an anticipated preterm delivery or after delivery in unanticipated cases. The random sequence of varying block sizes will be generated online and serially-numbered opaque sealed envelopes will be prepared. The enrolled infants will be then randomly allocated to receive 1 of 3 regimens of vitamin K after admission to the neonatal intensive care unit (0.3 mg IM, 0.5 mg IM, and 1 mg IM). The intervention is unblinded but the lab technician who process the blood samples and the radiologist who does the scans will not be aware of the allocation. The vitamin K preparation used will contain Phytomenadione (1.0 mg/0.5mL). As per the instructions of the investigator, the staff nurse, will prepare the drug and administer it to the infant using a 1 ml syringe along with a 26  G needle on the anterolateral aspect of the right thigh (left thigh if contraindicated on right for any reason), within 1 hour of admission in the NICU. Protein induced in vitamin K absence II (PIVKA-II), a sensitive biomarker of vitamin K deficiency, will be estimated in cord blood and on study days 5 and 28, by using Elecsys® PIVKA-II enzyme-linked immune sorbent assay (ELISA) based on double antibody sandwich technology.  PIVKA-II > 0.028 AU/ml is considered vitamin K deficient. Cranial ultrasonography (CUSG) will be routinely done in enrolled infants on days 1, 3, and 7, if birth weight < 1000 g and on days 3 and 7 if weight > 1000 g, or anytime as decided by the treating doctor. Any infant showing abnormal findings in the initial scans will be followed up by a weekly ultrasound. The CUSG grading for PIVH (Periventricular/Intraventricular hemorrhage) will be done according to Papile’s classification. During the entire study period, all the participants will be closely monitored for any bleeding and if detected, additional PIVKA-II levels with routine coagulation profile will be measured, to determine if the bleeding was due to VKDB and a single dose of 0.2mg IM of vitamin K will be immediately administered.