Vitamin K prophylaxis for newborns
Vitamin K at birth (intramuscular preferred) vs. No prophylaxis, placebo, or oral regimen · for Vitamin K deficiency bleeding (VKDB) · real-time analysis of 5 studies · updated 2026-05-29
Vitamin K at birth markedly reduces vitamin K deficiency bleeding. Two 1960s randomized trials show large reductions in early clinical bleeding, and surveillance data show that intramuscular prophylaxis nearly eliminates the severe late form, which oral regimens and no prophylaxis do not.
Efficacy (RCT): Efficacy evidence on clinical outcomes. Effects are risk ratios with number-needed-to-treat where a baseline risk is available. Glossary →
Late VKDB has never been tested in an RCT, so those estimates are observational. The large NNT reflects how rare the outcome is, not a weak treatment. Where a study shows a reported risk ratio instead of a 2×2 table, the original per-arm counts are not published.
Forest plot—Early clinical bleeding
Study results—Early clinical bleeding
| Study | Design | Dose / regimen | Treatment | Control | RR [95% CI] | Improvement | NNT | Weight |
|---|---|---|---|---|---|---|---|---|
| Sutherland 1967 note | RCT | Vitamin K vs placebo at birth | — | — | 0.19 [0.08–0.46] | 81% | 74 | 47% |
| Vietti 1960 note | RCT | Vitamin K1 IM at birth | — | — | 0.18 [0.08–0.42] | 82% | 9 | 53% |
RR < 1 favors treatment for outcomes where lower is better. Rows in gray have a confidence interval crossing 1 (individually inconclusive). “~” marks effects reported as OR/HR and treated as RR-approximations. “excl” = excluded from pooling (e.g. reviews).
Notes & interpretation
- Sutherland 1967—Moderate-to-severe bleeding. Per-arm counts not available; entered as the reported RR. Control risk set to reproduce the published NNT ≈ 74. Any-bleeding RR was 0.73 (0.56-0.96). Source: Sankar 2016 (PMC4862383).
- Vietti 1960—Per-arm counts not available in accessible sources; entered as the reported RR. Control risk set to reproduce the published NNT ≈ 9. Source: Sankar 2016 (PMC4862383).
Forest plot—Late VKDB (IM vs oral)
Study results—Late VKDB (IM vs oral)
| Study | Design | Dose / regimen | Treatment | Control | RR [95% CI] | Improvement | NNT | Weight |
|---|---|---|---|---|---|---|---|---|
| Sankar (IM vs single oral) 2016 note | cohort | Single IM dose vs single oral dose | — | — | 0.04 [0.01–0.14] | 96% | 74483 | 53% |
| Sankar (IM vs repeated oral) 2016 note | cohort | Single IM dose vs repeated oral doses | — | — | 0.28 [0.06–1.22] | 73% | 191571 | 47% |
RR < 1 favors treatment for outcomes where lower is better. Rows in gray have a confidence interval crossing 1 (individually inconclusive). “~” marks effects reported as OR/HR and treated as RR-approximations. “excl” = excluded from pooling (e.g. reviews).
Notes & interpretation
- Sankar (IM vs single oral) 2016—Inverted from the published single-oral-vs-IM RR 24.5 (7.4-81.0). Observational. Control (single oral) late-VKDB risk ≈ 1.4 per 100,000. Source: Sankar 2016 (PMC4862383).
- Sankar (IM vs repeated oral) 2016—Inverted from the published repeated-oral-vs-IM RR 3.64 (0.82-16.3); not statistically significant. Observational. Control (repeated oral) late-VKDB risk ≈ 0.72 per 100,000 (von Kries 2003). Source: Sankar 2016 (PMC4862383).
Forest plot—Biochemical deficiency
Study results—Biochemical deficiency
| Study | Design | Dose / regimen | Treatment | Control | RR [95% CI] | Improvement | NNT | Weight |
|---|---|---|---|---|---|---|---|---|
| Sharma / Ulusahin (Cochrane) 2000 note | RCT | IM vitamin K vs control | — | — | 0.43 [0.26–0.71] | 57% | — | 42% |
| Cochrane (oral PIVKA-II) 2000 note | RCT | Oral vitamin K vs control | — | — | 0.40 [0.26–0.61] | 60% | — | 58% |
RR < 1 favors treatment for outcomes where lower is better. Rows in gray have a confidence interval crossing 1 (individually inconclusive). “~” marks effects reported as OR/HR and treated as RR-approximations. “excl” = excluded from pooling (e.g. reviews).
Notes & interpretation
- Sharma / Ulusahin (Cochrane) 2000—Pooled PIVKA-II positivity from two randomized trials in the Cochrane review. Per-arm counts not exposed in the accessible HTML.
- Cochrane (oral PIVKA-II) 2000—Pooled PIVKA-II positivity at 3 days, oral vs control, from the Cochrane review (3 trials, n=118).
Background
VKDB (hemorrhagic disease of the newborn) is bleeding from the low vitamin K stores of newborns: early (≤24 h), classic (days 1–7), and late (weeks 2–12, often intracranial). A single dose at birth—intramuscular preferred—is standard prophylaxis. Clinical VKDB is rare, so most quantitative evidence is observational rather than randomized.
Topic methodology & caveats
Studies
- 2016 · cohort Sankar MJ, et al. Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. J Perinatol. 2016;36(Suppl 1):S29-S35.
- 2016 · cohort Sankar MJ, et al. Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. J Perinatol. 2016;36(Suppl 1):S29-S35.
- 2000 · RCT Puckett RM, Offringa M. Prophylactic vitamin K for vitamin K deficiency bleeding in neonates. Cochrane Database Syst Rev. 2000;(4):CD002776. (PIVKA-II, IM vs control: Sharma 1995, Ulusahin 1996.)
- 2000 · RCT Puckett RM, Offringa M. Prophylactic vitamin K for vitamin K deficiency bleeding in neonates. Cochrane Database Syst Rev. 2000;(4):CD002776. (PIVKA-II at 3 days, oral vs control, 3 trials, n=118.)
- 1967 · RCT Sutherland JM, Glueck HI, Gleser G. Hemorrhagic disease of the newborn: breast feeding as a necessary factor in the pathogenesis. Am J Dis Child. 1967;113(5):524-533. (Moderate-to-severe bleeding, as pooled in Sankar 2016.)
- 1960 · RCT Vietti TJ, Stephens JC, Bennett KR. Vitamin K1 prophylaxis in the newborn. JAMA. 1960. (Effect as pooled in Sankar 2016 / Cochrane 2000.)