| Methods |
Randomisation: method not stated
Single center and home births
Blinding of outcome measurement: yes
Infants were excluded because of cessation of breast feeding and sampling errors: at one month 10 infants in the oral group and 13 infants in the IM group, at three months 77 infants in the oral group and 77 in the IM group had been excluded. At two weeks 20 (12.1%) infants in the oral group and 26 (15.7%) in the IM group had been excluded or lost for follow‐up for the PIVKA analysis, at one month this was 30 (18.2%) and 39 (23.5%) infants, respectively, and at three months 97 (58.8%) and 103 (62.5%) infants, respectively. At two weeks 91 (55.2%) infants in the oral group and 102 (61.4%) in the IM group had been excluded or lost to follow‐up for the analysis of vitamin K levels, at one month this was 71 (43.0%) and 82 (49.4%) infants, respectively and at three months 103 (62.4%) and 109 (65.7%) infants, respectively. |
| Participants |
331 infants, delivered spontaneously and vaginally, were randomized, 166 to the IM group and 165 to the oral group. Inclusion criteria: Intention to breast feed, GA at least 37 wk, BW over the 2.3 percentile, Apgar score at least seven at five minutes, healthy mother.
Exclusions: treatment of mother with antibiotics, anti‐coagulants or anti‐epileptics. Cessation of breast feeding.
Mean BW in kg (SD), oral group: 3.424 (0.439). IM group: 3.417 (0.440)
Mean GA in wk (SD), oral group: 39.8 (1.3), IM group: 40.1 (1.2) |
| Interventions |
1 mg oral vitamin K1 (Konakion, Hoffman‐La Roche) (n=165) or 1 mg IM vitamin K1 (Konakion, Hoffman‐La Roche) (n=166) |
| Outcomes |
Plasma vitamin K1 levels (pg/ml) and PIVKA‐II presence (>0.10 ‐ >0.13 AU/ml or > 2ng/ ml) at two weeks, one month and three months. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
