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 |