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. 2000 Oct 23;2000(4):CD002776. doi: 10.1002/14651858.CD002776

Bakhshi 1996.

Methods Randomisation: Block 
 Single center. Blinding of outcome measurement: not stated 
 Complete follow‐up: yes 
 Two (7.5%) infants in the oral group were excluded for the use of top milk; no infants were excluded in the IM group.
Participants 54 infants were randomized, 27 in each group. They were exclusively breast fed, term infants with normal Apgar scores. 
 Exclusion criteria: congenital malformations, IV fluids to infant, treatment of mother with drugs including phenobarbitone, anti‐coagulants and anti‐tubercular agents, maternal hypertension. 
 Mean BW in kg (SD), oral group: 2.9 (0.2). IM group: 2.8 (0.3) 
 Mean GA in wk (SD), oral group: 38.8 (1.0), IM group: 38.7 (1.3)
Interventions 2.0 mg of oral vitamin K3 (n=27) or 1.0 mg of IM vitamin K3 (n=27) both given within four hours after birth
Outcomes PIVKA‐II presence (>0.10 ‐ >0.13 AU/ml or > 2ng/ ml) and prolonged prothrombin time (>1.5 X normal) at 72 +/‐ 12 hours
Notes Water soluble vitamin K was used in this study
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear