Summary of findings 1. Lactoferrin supplementation compared to control for very low birth weight infants.
| Lactoferrin supplementation compared to control for very low birth weight infants | ||||||
| Patient or population: prevention of sepsis and necrotizing enterocolitis in preterm infants Setting: Neonatal intensive care unit Intervention: lactoferrin supplementation with enteral feeds Comparison: placebo | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| Without lactoferrin supplementation with enteral feeds | With lactoferrin supplementation with enteral feeds | Difference | ||||
| All‐cause Mortality № of participants: 5510 (11 RCTs) | RR 0.97 (0.79 to 1.20) | Study population | ⊕⊝⊝⊝
VERY LOW1,2,3 |
Risk of bias, imprecision and funnel plot asymmetry | ||
| 5.9% | 5.7% (4.6 to 7) | 0.2% fewer (1.2 fewer to 1.2 more) | ||||
| necrotizing enterocolitis № of participants: 4874 (7 RCTs) | RR 0.90 (0.69 to 1.17) | Study population | ⊕⊕⊝⊝ LOW1,2 | Risk of bias in the included trials, and imprecision | ||
| 4.7% | 4.2% (3.2 to 5.5) | 0.5% fewer (1.4 fewer to 0.8 more) | ||||
| Late onset sepsis
№ of participants: 5425
(12 RCTs) [Data includes both suspected and confirmed sepsis] |
RR 0.80 (0.72 to 0.89) | Study population | ⊕⊕⊝⊝ LOW1,2 | Risk of bias in the included trials, and asymmetry of the funnel plot | ||
| 21.1% | 17.3% (15.6 to 19.2) | 3.8% fewer (5.5 fewer to 1.9 fewer) | ||||
| Bacterial sepsis № of participants: 3565 (8 RCTs) | RR 0.86 (0.74 to 1.00) | Study population | ⊕⊕⊝⊝ LOW1,2 | Risk of bias and. moderate heterogeneity | ||
| 16.1% | 13.9% (11.9 to 16.1) | 2.3% fewer (4.2 fewer to 0 fewer) | ||||
| Fungal infection № of participants: 3266 (6 RCTs) | RR 0.23 (0.10 to 0.54) | Study population | ⊕⊕⊝⊝ LOW1,2 | Risk of bias and moderate heterogeneity | ||
| 1.7% | 0.4% (0.2 to 0.9) | 1.3% fewer (1.5 fewer to 0.8 fewer) | ||||
| Chronic lung disease № of participants: 2984 (5 RCTs) | RR 1.00 (0.89 to 1.12) | Study population | ⊕⊕⊝⊝ LOW1,2 | Low risk of bias, moderate heterogeneity and imprecision | ||
| 27.2% | 27.2% (24.2 to 30.5) | 0.0% fewer (3 fewer to 3.3 more) | ||||
| Length of hospital stay № of participants: 1079 (3 RCTs) | ‐ | The mean length of hospital stay without lactoferrin supplementation with enteral feeds was 34.14 days | ‐ | MD 2.38 days lower (4.67 lower to 0.09 lower) | ⊕⊝⊝⊝ VERY LOW1,2,3 | Risk of bias and severe heterogeneity |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1Risk of bias, 2imprecision, 3funnel plot asymmetry