Summary of findings 2. Higher dose vitamin K compared to lower dose vitamin K for preterm infants.
| Higher dose vitamin K compared to lower dose vitamin K for preterm infants | ||||||
| Patient or population: preterm infants Setting: neonatal intensive care unit Intervention: higher dose intramuscular (IM) vitamin K Comparison: lower dose IM vitamin K | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with lower dose vitamin K | Risk with higher dose vitamin K | |||||
| Bleeding complications: 0.2 mg IM versus 0.5 mg IM | Study population | RR 0.12 (0.01 to 2.11) | 54 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 143 per 1000 | 17 per 1000 (1 to 301) | |||||
| Intraventricular hemorrhage > Grade II: 0.2 mg IM versus 0.5 mg IM | Study population | RR 0.36 (0.04 to 3.24) | 54 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 107 per 1000 | 39 per 1000 (4 to 347) | |||||
| Presence of PIVKA II at day 5: 0.2 mg IM versus 0.5 mg IM | Study population | RR 1.36 (0.24 to 7.57) | 61 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 69 per 1000 | 94 per 1000 (17 to 522) | |||||
| Presence of PIVKA II at day 25: 0.2 mg IM versus 0.5 mg IM | Study population | RR 0.96 (0.06 to 14.60) | 53 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 38 per 1000 | 37 per 1000 (2 to 562) | |||||
| Necrotizing enterocolitis: 0.2 mg IM versus 0.5 mg IM | Study population | RR 1.08 (0.16 to 7.10) | 54 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 71 per 1000 | 77 per 1000 (11 to 507) | |||||
| Sepsis: 0.2 mg IM versus 0.5 mg IM | Study population | RR 0.86 (0.26 to 2.86) | 54 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 179 per 1000 | 154 per 1000 (46 to 511) | |||||
| Mortality (all infants): 0.2 mg IM versus 0.5 mg IM | Study population | RR 2.13 (0.60 to 7.51) | 65 (1 RCT) | ⊕⊕⊝⊝ low1 | ||
| 97 per 1000 | 206 per 1000 (58 to 727) | |||||
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Abbreviations: CI: confidence interval; intravenous: IV; intramuscular: IM; RR: risk ratio; OR: odds ratio. | ||||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect. | ||||||
1We downgraded by two levels due to the small sample size from one included trial.