Summary of findings 1. Synbiotics compared to control in very preterm or very low birth weight infants.
| Synbiotics compared to control in very preterm or very low birth weight infants | ||||||
| Patient or population: very preterm or very low birth weight infants Setting: neonatal care centres globally Intervention: synbiotics (typically Bifidobacterium spp., Lactobacillus spp., plus fructo‐ or galacto‐oligosaccharides (or both) Comparison: control | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Risk ratio (95% CI) | Absolute effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | |
| Risk with control | Risk with Probiotics | |||||
| Necrotising enterocolitis (before hospital discharge) | 83 per 1000 | 15 per 1000 (7 to 33) |
0.18 (0.09 to 0.40) | 70 per 1000 fewer (100 fewer to 40 fewer per 1000) | 907 (6 studies) | ⊕⊕⊝⊝ Lowa |
| Mortality (all‐cause before hospital discharge) | 93 per 1000 | 50 per 1000 (31 to 79) | 0.53 (0.33 to 0.85) | 50 per 1000 fewer (120 fewer to 100 fewer per 1000) | 925 (6 studies) | ⊕⊕⊝⊝ Low,b,c |
| Late‐onset Invasive infection (before hospital discharge) | 134 per 1000 | 113 per 1000 (78 to 162) | 0.84 (0.58 to 1.21) | 20 per 1000 fewer (70 fewer to 30 more per 1000) | 707 (5 studies) | ⊕⊝⊝⊝ Very lowc,d |
| Neurodevelopmental impairment (assessed beyond infancy) | None of the included trials reported neurodevelopmental outcomes. | |||||
| *The risk in the intervention group (and its 95% confidence interval (CI) is based on the assumed risk in the comparison group and the relative effect of the intervention and its 95% CI. | ||||||
| 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. | ||||||
a Methodological limitations in trials (high risk of bias due to uncertainty about methods used to generate random sequence, conceal allocation, and mask outcome assessment): downgraded two levels for NEC because of subjectivity in ascertainment and diagnosis.
b Methodological limitations in trials (high risk of bias due to uncertainty about methods used to generate random sequence, conceal allocation, and mask outcome assessment): downgraded one level for all‐cause mortality before discharge because of objectivity in ascertainment and diagnosis.
c Serious imprecision of effect estimate (low number of events).
d Methodological limitations in trials (high risk of bias due to uncertainty about methods used to generate random sequence, conceal allocation, and mask outcome assessment): downgraded two levels for late‐onset invasive infection because of subjectivity in ascertainment and diagnosis.