Lactoferrin for Sepsis Newborn
Verdict: Published with Warning
Across 5 PubMed studies, the evidence for Lactoferrin in Sepsis Newborn grades Tier C — weak evidence. Effective, but with safety or population caveats.
C 🟠 C Weak Evidence Published with Warning
Why this grade7-layer evidence engine
⚖️
Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.51
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Published with Warning
Confidence
79%
Broadly consistent
Evidence level
E1
Cochrane high-quality SR/MA
▸View the full decision path (audit trail)
- compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.51
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 高階證據未達主導 (1 positive vs 1 negative)，由 raw_score 決定
- tier_strict_requirement_check — Tier 條件達標，未降階
- detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (5)L2 · primary research & systematic reviews
Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants
Finding: Lactoferrin alone modestly reduced late-onset sepsis (typical RR 0.82, 95% CI 0.74-0.91; NNT 25) but had no effect on NEC stage II/III (RR 1.10, 95% CI 0.86-1.41) or all-cause mortality (RR 0.90, 95% CI 0.69-1.17), all at low-to-moderate certainty.
View on PubMed Enteral Lactoferrin Supplementation for Preventing Sepsis and Necrotizing Enterocolitis in Preterm Infants: A Meta-Analysis With Trial Sequential Analysis of RCTs
Finding: Lactoferrin did not significantly reduce overall late-onset sepsis (RR 0.63, 95% CI 0.38-1.02, p=0.06), NEC (RR 0.68, 95% CI 0.30-1.52, p=0.35) or mortality (RR 0.89, p=0.69); only the <1500 g subgroup reached significance for sepsis (RR 0.43, 95% CI 0.22-0.84, p=0.01), and trial sequential analysis judged the evidence insufficient.
View on PubMed Prophylactic lactoferrin for preventing late-onset sepsis and NEC in preterm infants: A PRISMA-compliant systematic review and meta-analysis
Finding: Lactoferrin significantly reduced culture-proven late-onset sepsis (RR 0.47, 95% CI 0.33-0.67, p<0.01) and NEC stage II+ (RR 0.40, 95% CI 0.18-0.86, p<0.01), but did not significantly reduce all-cause mortality (RR 0.70, 95% CI 0.38-1.30, p=0.16).
View on PubMed Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial (ELFIN)
Finding: In the largest and most rigorous trial to date, enteral bovine lactoferrin did not reduce late-onset infection (316/1093 [29%] vs 334/1089 [31%]; adjusted RR 0.95, 95% CI 0.86-1.04, p=0.233), giving a clearly null result.
View on PubMed Comparative efficacy of different single drugs to prevent necrotizing enterocolitis in preterm infants: an updated systematic review and network meta-analysis
Finding: Lactoferrin ranked best for preventing NEC-associated sepsis (SUCRA 18.7%, lowest event probability) but was only mid-ranked for NEC itself (SUCRA 61.7%); arginine, not lactoferrin, was the top-ranked agent for NEC and recommended first-line, and no lactoferrin-vs-placebo effect estimate was reported.
View on PubMed Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …
L4a US FDA
Supportive
FDA has no questions source↗
L4b EU EFSA
Supportive
L4d TW TFDA / 衛福部
Supportive
第（八）類 營養添加劑 編號08112 乳鐵蛋白 — 自中華民國一百十二年一月一日施行 source↗
L5a NIH Office of Dietary Supplements
Cautious
L5e Specialty Society (condition-mapped)
Supportive
Prophylactic oral administration of bovine lactoferrin reduces the incidence of invasive fungal infection in preterm VLBW neonates, with no effect seen on colonization. The protective effect on invasive fungal infection is likely due to limitation of the ability of fungal colonies to progress toward invasion and systemic disease in colonized infants. Bovine lactoferrin supplementation alone or … source↗