Vitamin K for Hemorrhage Prevention Newborn

Verdict: Published

Across 4 PubMed studies, the evidence for Vitamin K in Hemorrhage Prevention Newborn grades Tier A — moderate evidence.

A 🔵 A Moderate Evidence Published

🔬Why this grade7-layer evidence engine

⚖️

Scoring transparency

All scores computed by a 7-layer evidence engine — fully auditable
Raw score 0.72
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
A · Published
Confidence
93%
Highly consistent evidence
Evidence level
E1
Cochrane high-quality SR/MA

How strongly each layer supports this effect

lower = less supportive
L1 ExamineGlobal benchmark
0.50
L2 PubMedPrimary literature
0.70
L3 MechanismPlausibility
0.75
L5 Clinical bodiesAuthoritative stance
0.78
L11 AI re-checkIndependent read
0.80
Against Mixed Supports
View the full decision path (audit trail)
  1. compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.723
  2. tier_from_score — 依分數區間映射至 tier letter
  3. apply_hec_rules — 高品質 SR/MA 顯示 positive (2 篇 > 0 negative)
  4. tier_strict_requirement_check — Tier 條件達標,未降階
  5. detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
  6. decide_status — 依 tier + dispute 結果決定 status

📄PubMed studies (4)L2 · primary research & systematic reviews

Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review
PMID: 27109090 2016 系統性回顧
Finding: Pooled data from 4 nationwide surveillance studies showed IM/subcutaneous vitamin K prophylaxis vs none reduced late VKDB with RR 0.02 (95% CI 0.00-0.10), while a single oral dose was far inferior to IM (RR 24.5, 95% CI 7.4-81.0).
Government Effect size: RR 0.02 (95% CI 0.00-0.10) IM vs none for late VKDB; oral-single vs IM RR 24.5 (95% CI 7.4-81.0)
View on PubMed
Prophylactic vitamin K for vitamin K deficiency bleeding in neonates
PMID: 11034761 2000 Cochrane Review
Finding: Across 13 RCTs, a single 1 mg IM dose significantly reduced clinical bleeding at days 1-7 (including post-circumcision bleeding, RR 0.18, 95% CI 0.08-0.42) and improved coagulation indices, but neither IM nor oral vitamin K was ever RCT-tested against late VKDB.
Government Effect size: Post-circumcision bleeding RR 0.18 (95% CI 0.08-0.42); any bleeding RR 0.73 (95% CI 0.56-0.96) in one trial
View on PubMed
Vitamin K deficiency bleeding in children with cholestatic liver disease: a systematic review and meta-analysis
PMID: 40470336 2025 統合分析
Finding: Across 37 studies (mostly case reports/series), pooled VKD prevalence by abnormal coagulation testing was 10% (95% CI 5-14%, I2=0%), and parenteral vitamin K showed a clear advantage over oral for VKD/VKDB prevention (oral had earliest median bleeding onset at 44.5 vs 86.0 days IM).
🟠 Limited quality Effect size: Pooled VKD prevalence 10% (95% CI 5-14%) by abnormal coagulation; 56% (95% CI 45-68%) by elevated PIVKA-II
View on PubMed
Prophylactic vitamin K for the prevention of vitamin K deficiency bleeding in preterm neonates
PMID: 29401369 2018 Cochrane Review
Finding: Only 1 small trial met criteria and no study compared vitamin K to no treatment, so the primary clinical bleeding endpoint could not be assessed; the trial only showed that 0.5 mg IM gave higher day-25 vitamin K1 levels than 0.2 mg IV/IM (surrogate markers), with no measurable bleeding events.
🟠 Limited quality Government
View on PubMed

🏛️Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …

L4a US FDA
Supportive
Vitamin K1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates source↗
L4b EU EFSA
Supportive
a cause and effect relationship has been established between the dietary intake of vitamin K and normal blood coagulation ... and the maintenance of normal bone source↗
L4c UK NHS
Cautious
You should be able to get all the vitamin K you need by eating a varied and balanced diet. Any vitamin K your body does not need immediately is stored in the liver for future use, so you do not need it in your diet every day. source↗
L4d TW TFDA / 衛福部
Supportive
成年男性 120 微克/日,女性 90 微克/日(足夠攝取量 AI) source↗
L4e WHO
Supportive
vitamin K1 should be given to all newborns as a single, intramuscular dose of 0.5–1 mg source↗
L5a NIH Office of Dietary Supplements
Supportive
Vitamin K, the generic name for a family of compounds with a common chemical structure of 2-methyl-1,4-naphthoquinone, is a fat-soluble vitamin source↗
L5b Mayo Clinic
Supportive
Healthcare professionals recommend all babies receive a vitamin K injection at birth to help their blood clot effectively. Since 1961, the American Academy of Pediatrics has recommended a single dose of vitamin K injected into the thigh muscle of a newborn infant to prevent bleeding, with the recommended dose based on the infant's weight and given within six hours of birth. There is a risk of b… source↗
L5c Cleveland Clinic
Supportive
The vitamin K shot helps prevent a serious bleeding condition called vitamin K deficiency bleeding (VKDB). Without it, as many as 1 in 60 babies may develop VKDB. Among babies who receive the shot, that falls to fewer than 1 in 100,000. Giving vitamin K at birth turns a real, measurable risk into a rare one. source↗
L5e Specialty Society (condition-mapped)
Supportive
Vitamin K should be administered to all newborn infants weighing >1500 g as a single, intramuscular dose of 1 mg within six hours of birth. Preterm infants weighing ≤1500 g should receive a vitamin K dose of 0.3 mg/kg to 0.5 mg/kg as a single, intramuscular dose. Pediatricians and other health care providers must be aware of the benefits of vitamin K administration as well as the risks of refus… source↗
PMID 100% verifiedevery citation checked via NCBI Entrez
🔬4 PubMed studiesindependently re-checked by multiple sub-agents
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