Methods |
Randomisation: method not stated
Multi center
Blinding of outcome measurement: not stated
Complete follow‐up: not stated
Post‐randomisation exclusions: not stated |
Participants |
100 exclusively breast fed infants with birth weights above 2.5 kg were randomized, 25 in each of the four groups. Groups had comparable characteristics |
Interventions |
1 mg IM vitamin K3 (menadione sodium bisulphite) (n=25) or 0.5 mg IM vitamin K3 (n=25) or 1 mg oral vitamin K3 (n=25) , all given immediately after birth, or nothing (n=25) |
Outcomes |
Prothrombin index (% of normal) at 36‐72 hours |
Notes |
Water soluble vitamin K was used in this study.
The group that received 0.5 mg of IM vitamin K was excluded, because it was not possible to enter both IM groups into the data tables and a dose of 1.0 mg IM is more commonly used. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |