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Study flow diagram: review update 2022.

Figuras y tablas -
Figure 1

Study flow diagram: review update 2022.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.1 Necrotising enterocolitis.

Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.1 Necrotising enterocolitis.

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Funnel plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.1 Necrotising enterocolitis.

Figuras y tablas -
Figure 4

Funnel plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.1 Necrotising enterocolitis.

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Forest plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.2 Mortality.

Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.2 Mortality.

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Funnel plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.2 Mortality.

Figuras y tablas -
Figure 6

Funnel plot of comparison: 1 Probiotics versus placebo or no probiotics, outcome: 1.2 Mortality.

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 1: Necrotising enterocolitis

Figuras y tablas -
Analysis 1.1

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 1: Necrotising enterocolitis

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 2: All‐cause mortality

Figuras y tablas -
Analysis 1.2

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 2: All‐cause mortality

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 3: Late‐onset invasive infection

Figuras y tablas -
Analysis 1.3

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 3: Late‐onset invasive infection

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 4: Duration of hospitalisation from birth (days)

Figuras y tablas -
Analysis 1.4

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 4: Duration of hospitalisation from birth (days)

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 5: Neurodevelopmental impairment

Figuras y tablas -
Analysis 1.5

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 5: Neurodevelopmental impairment

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 6: Cerebral palsy

Figuras y tablas -
Analysis 1.6

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 6: Cerebral palsy

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 7: Visual impairment

Figuras y tablas -
Analysis 1.7

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 7: Visual impairment

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 8: Hearing impairment

Figuras y tablas -
Analysis 1.8

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 8: Hearing impairment

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Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 9: Cognitive performance

Figuras y tablas -
Analysis 1.9

Comparison 1: Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants), Outcome 9: Cognitive performance

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Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 1: Necrotising enterocolitis

Figuras y tablas -
Analysis 2.1

Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 1: Necrotising enterocolitis

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Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 2: All‐cause mortality

Figuras y tablas -
Analysis 2.2

Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 2: All‐cause mortality

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Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 3: Late‐onset invasive infection

Figuras y tablas -
Analysis 2.3

Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 3: Late‐onset invasive infection

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Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 4: Duration of hospitalisation from birth (days)

Figuras y tablas -
Analysis 2.4

Comparison 2: Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants), Outcome 4: Duration of hospitalisation from birth (days)

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Comparison 3: Subgroup analysis by type of feeding, Outcome 1: Necrotising enterocolitis

Figuras y tablas -
Analysis 3.1

Comparison 3: Subgroup analysis by type of feeding, Outcome 1: Necrotising enterocolitis

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Comparison 3: Subgroup analysis by type of feeding, Outcome 2: All‐cause mortality

Figuras y tablas -
Analysis 3.2

Comparison 3: Subgroup analysis by type of feeding, Outcome 2: All‐cause mortality

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Comparison 3: Subgroup analysis by type of feeding, Outcome 3: Late‐onset invasive infection

Figuras y tablas -
Analysis 3.3

Comparison 3: Subgroup analysis by type of feeding, Outcome 3: Late‐onset invasive infection

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Comparison 3: Subgroup analysis by type of feeding, Outcome 4: Duration of hospitalisation from birth (days)

Figuras y tablas -
Analysis 3.4

Comparison 3: Subgroup analysis by type of feeding, Outcome 4: Duration of hospitalisation from birth (days)

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 1: Necrotising enterocolitis

Figuras y tablas -
Analysis 4.1

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 1: Necrotising enterocolitis

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 2: All‐cause mortality

Figuras y tablas -
Analysis 4.2

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 2: All‐cause mortality

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 3: Late‐onset invasive infection

Figuras y tablas -
Analysis 4.3

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 3: Late‐onset invasive infection

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 4: Duration of hospitalisation from birth (days)

Figuras y tablas -
Analysis 4.4

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 4: Duration of hospitalisation from birth (days)

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 5: Neurodevelopmental impairment

Figuras y tablas -
Analysis 4.5

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 5: Neurodevelopmental impairment

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 6: Cerebral palsy

Figuras y tablas -
Analysis 4.6

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 6: Cerebral palsy

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 7: Visual impairment

Figuras y tablas -
Analysis 4.7

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 7: Visual impairment

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Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 8: Hearing impairment

Figuras y tablas -
Analysis 4.8

Comparison 4: Sensitivity analyses: trials at low risk of bias, Outcome 8: Hearing impairment

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Summary of findings 1. Probiotics compared to control in very preterm or very low birth weight infants

Probiotics compared to placebo or no probiotics in very preterm or very low birth weight infants

Patient or population: very preterm or very low birth weight infants
Setting: neonatal care centres worldwide
Intervention: probiotics
Comparison: placebo or no probiotics

Outcomes

Anticipated absolute effects* (95% CI)

Risk ratio
(95% CI)

№ of participants
(trials)

Certainty of the evidence
(GRADE)

Risk with control

Risk with probiotics

Necrotising enterocolitis (before hospital discharge)

60 per 1000

33 per 1000
(28 to 39)

0.54
(0.46 to 0.65)

10,918 (57)

⊕⊕⊝⊝
Lowa,b

All‐cause mortality (before hospital discharge)

63 per 1000

48 per 1000
(42 to 57)

0.77 (0.66 to 0.90)

10,484 (54)

⊕⊕⊕⊝
Moderatea

Late‐onset invasive infection (before hospital discharge)

173 per 1000

154 per 1000
(142 to 168)

0.89 (0.82 to 0.97)

9876 (49)

⊕⊕⊕⊝
Moderatea

Neurodevelopmental impairment (18 months to 3 years)

194 per 1000

200 per 1000
(163 to 245)

1.03
(0.84 to 1.26)

1518 (5)

⊕⊕⊝⊝
Lowa,c

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval.

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.

aDowngraded one level for high risk of bias due to uncertainty about methods used to generate random sequence, conceal allocation, and mask outcome assessment.
bDowngraded one level for publication bias (funnel plot asymmetry and statistical evidence consistent with trial size; trials favouring controls missing).
cDowngraded one level for serious imprecision of effect estimate (95% CI around estimate consistent with substantial harm or benefit).

Figuras y tablas -
Summary of findings 1. Probiotics compared to control in very preterm or very low birth weight infants
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Summary of findings 2. Probiotics compared to control in extremely preterm or extremely low birth weight infants

Probiotics compared to placebo or no probiotics in extremely preterm or extremely low birth weight infants

Patient or population: extremely preterm or extremely low birth weight infants
Setting: neonatal care centres globally
Intervention: probiotics
Comparison: placebo or no probiotics

Outcomes

Anticipated absolute effects* (95% CI)

Risk ratio
(95% CI)

№ of participants
(trials)

Certainty of the evidence
(GRADE)

Risk with control (extremely preterm or ELBW)

Risk with Probiotics

Necrotising enterocolitis (before hospital discharge)

94 per 1000

87 per 1000
(65 to 114)

0.92
(0.69 to 1.22)

1836 (10)

⊕⊕⊝⊝
Lowa

All‐cause mortality (before hospital discharge)

132 per 1000

121 per 1000
(95 to 156)

0.92
(0.72 to 1.18)

1723 (7)

⊕⊕⊝⊝
Lowa

Late‐onset invasive infection (before hospital discharge)

274 per 1000

255 per 1000
(214 to 299)

0.93
(0.78 to 1.09)

1533 (7)

⊕⊕⊝⊝
Lowa

Neurodevelopmental impairment (18 months to 3 years)

No trials provided subgroup data for analysis.

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval.

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.

aDowngraded one level for high risk of bias (uncertainty about methods used to generate random sequence, conceal allocation, and mask assessments) in many trials, and one level for serious imprecision of effect estimate (95% CI around estimate consistent with substantial harm or benefit).

Figuras y tablas -
Summary of findings 2. Probiotics compared to control in extremely preterm or extremely low birth weight infants
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Comparison 1. Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Necrotising enterocolitis Show forest plot

57

10918

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.46, 0.65]

1.1.1 Bifidobacterium spp.

14

2988

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.54, 0.96]

1.1.2 Lactobacillus spp.

13

2052

Risk Ratio (M‐H, Fixed, 95% CI)

0.45 [0.28, 0.71]

1.1.3 Sacchromyces spp.

4

621

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.44, 1.50]

1.1.4 Bacillus spp.

2

465

Risk Ratio (M‐H, Fixed, 95% CI)

0.61 [0.23, 1.61]

1.1.5 Bifidobacterium spp. plus Lactobacillus spp.

13

2303

Risk Ratio (M‐H, Fixed, 95% CI)

0.39 [0.25, 0.62]

1.1.6 Bifidobacterium spp. plus Streptococcus spp.

2

1244

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.19, 0.68]

1.1.7 Bifidobacterium spp. plus Lactobacillus spp. plus Sacchromyces spp.

4

583

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.28, 1.58]

1.1.8 Bifidobacterium spp. plus Lactobacillus spp. plus Streptococcus spp.

5

662

Risk Ratio (M‐H, Fixed, 95% CI)

0.42 [0.22, 0.77]

1.2 All‐cause mortality Show forest plot

54

10484

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.66, 0.90]

1.2.1 Bifidobacterium spp.

12

2761

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.58, 1.09]

1.2.2 Lactobacillus spp.

13

2052

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.60, 1.37]

1.2.3 Sacchromyces spp.

3

534

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.46, 2.70]

1.2.4 Bacillus spp.

2

465

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.45, 1.69]

1.2.5 Bifidobacterium spp. plus Lactobacillus spp.

14

2333

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.48, 0.85]

1.2.6 Bifidobacterium spp. plus Streptococcus spp.

2

1244

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.52, 1.35]

1.2.7 Bifidobacterium spp. plus Lactobacillus spp. plus Sacchromyces spp.

4

583

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.30, 1.49]

1.2.8 Bifidobacterium spp. plus Lactobacillus spp. plus Streptococcus spp.

4

512

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.39, 1.42]

1.3 Late‐onset invasive infection Show forest plot

49

9876

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.82, 0.97]

1.3.1 Bifidobacterium spp.

12

2736

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.70, 1.02]

1.3.2 Lactobacillus spp.

12

2022

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.74, 1.17]

1.3.3 Sacchromyces spp.

4

621

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.58, 1.22]

1.3.4 Bacillus spp.

2

465

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.67, 1.51]

1.3.5 Bifidobacterium spp. plus Lactobacillus spp.

11

1975

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.81, 1.11]

1.3.6 Bifidobacterium spp. plus Streptococcus spp.

2

1244

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.72, 1.17]

1.3.7 Bifidobacterium spp. plus Lactobacillus spp. plus Sacchromyces spp.

4

583

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.53, 1.18]

1.3.8 Bifidobacterium spp. plus Lactobacillus spp. plus Streptococcus spp.

2

230

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.63, 1.00]

1.4 Duration of hospitalisation from birth (days) Show forest plot

24

5572

Mean Difference (IV, Fixed, 95% CI)

‐1.68 [‐3.08, ‐0.28]

1.4.1 Bifidobacterium spp.

4

1945

Mean Difference (IV, Fixed, 95% CI)

0.51 [‐2.98, 4.01]

1.4.2 Lactobacillus spp.

5

269

Mean Difference (IV, Fixed, 95% CI)

‐3.65 [‐7.76, 0.45]

1.4.3 Sacchromyces spp.

2

470

Mean Difference (IV, Fixed, 95% CI)

‐2.88 [‐8.06, 2.29]

1.4.4 Bifidobacterium spp. plus Lactobacillus spp.

8

1327

Mean Difference (IV, Fixed, 95% CI)

‐0.90 [‐3.28, 1.47]

1.4.5 Bifidobacterium spp. plus Streptococcus spp.

1

1044

Mean Difference (IV, Fixed, 95% CI)

‐3.00 [‐6.28, 0.28]

1.4.6 Bifidobacterium spp. plus Lactobacillus spp. plus Sacchromyces spp.

2

231

Mean Difference (IV, Fixed, 95% CI)

‐5.65 [‐11.68, 0.38]

1.4.7 Bifidobacterium spp. plus Lactobacillus spp. plus Streptococcus spp.

2

286

Mean Difference (IV, Fixed, 95% CI)

0.65 [‐4.86, 6.16]

1.5 Neurodevelopmental impairment Show forest plot

5

1518

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.84, 1.26]

1.5.1 Bifidobacterium spp.

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.34, 1.72]

1.5.2 Lactobacillus spp.

1

249

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.69, 1.48]

1.5.3 Bacillus spp.

1

174

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.58, 2.07]

1.5.4 Bifidobacterium spp. plus Streptococcus spp.

1

664

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.69, 1.36]

1.5.5 Bifidobacterium spp. plus Lactobacillus spp.

1

269

Risk Ratio (M‐H, Fixed, 95% CI)

1.27 [0.81, 1.98]

1.6 Cerebral palsy Show forest plot

5

1512

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.74, 1.72]

1.6.1 Bifidobacterium spp.

1

156

Risk Ratio (M‐H, Fixed, 95% CI)

0.38 [0.10, 1.36]

1.6.2 Lactobacillus spp.

1

249

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.40, 2.08]

1.6.3 Bacillus spp.

1

174

Risk Ratio (M‐H, Fixed, 95% CI)

2.05 [0.38, 10.88]

1.6.4 Bifidobacterium spp. plus Streptococcus spp.

1

664

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [0.67, 2.58]

1.6.5 Bifidobacterium spp. plus Lactobacillus spp.

1

269

Risk Ratio (M‐H, Fixed, 95% CI)

2.28 [0.62, 8.41]

1.7 Visual impairment Show forest plot

4

1356

Risk Ratio (M‐H, Fixed, 95% CI)

0.50 [0.14, 1.80]

1.7.1 Bifidobacterium spp.

1

174

Risk Ratio (M‐H, Fixed, 95% CI)

0.51 [0.05, 5.54]

1.7.2 Lactobacillus spp.

1

0

Risk Ratio (M‐H, Fixed, 95% CI)

Not estimable

1.7.3 Bifidobacterium spp. plus Streptococcus spp.

1

664

Risk Ratio (M‐H, Fixed, 95% CI)

2.91 [0.12, 71.21]

1.7.4 Bifidobacterium spp. plus Lactobacillus spp.

1

269

Risk Ratio (M‐H, Fixed, 95% CI)

0.21 [0.02, 1.89]

1.8 Hearing impairment Show forest plot

4

1356

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.18, 1.17]

1.8.1 Bifidobacterium spp.

1

174

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.07, 16.10]

1.8.2 Lactobacillus spp.

1

249

Risk Ratio (M‐H, Fixed, 95% CI)

3.02 [0.12, 73.52]

1.8.3 Bifidobacterium spp. plus Streptococcus spp.

1

664

Risk Ratio (M‐H, Fixed, 95% CI)

0.18 [0.04, 0.79]

1.8.4 Bifidobacterium spp. plus Lactobacillus spp.

1

269

Risk Ratio (M‐H, Fixed, 95% CI)

1.71 [0.16, 18.64]

1.9 Cognitive performance Show forest plot

1

52

Mean Difference (IV, Fixed, 95% CI)

‐1.00 [‐6.38, 4.38]
Figuras y tablas -
Comparison 1. Probiotics versus placebo or no probiotics (very preterm or very low birth weight infants)
Ir a la tabla de la revisión
Comparison 2. Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

2.1 Necrotising enterocolitis Show forest plot

10

1836

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.69, 1.22]

2.1.1 Bifidobacterium spp.

2

665

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.70, 1.43]

2.1.2 Lactobacillus spp.

2

330

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.36, 1.48]

2.1.3 Bacillus spp.

1

0

Risk Ratio (M‐H, Fixed, 95% CI)

Not estimable

2.1.4 Bifidobacterium spp. plus Lactobacillus spp.

4

247

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.38, 3.92]

2.1.5 Bifidobacterium spp. plus Streptococcus spp.

1

474

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.33, 1.60]

2.2 All‐cause mortality Show forest plot

7

1723

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.72, 1.18]

2.2.1 Bifidobacterium spp.

1

474

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.60, 1.61]

2.2.2 Lactobacillus spp.

2

330

Risk Ratio (M‐H, Fixed, 95% CI)

0.78 [0.42, 1.42]

2.2.3 Bacillus clausii

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.36, 2.08]

2.2.4 Bifidobacterium spp. plus Lactobacillus spp.

2

162

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.36, 4.10]

2.2.5 Bifidobacterium spp. plus Streptococcus spp.

1

637

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.65, 1.35]

2.3 Late‐onset invasive infection Show forest plot

7

1533

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.78, 1.09]

2.3.1 Bifidobacterium spp.

2

642

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.73, 1.37]

2.3.2 Lactobacillus spp.

1

134

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.67, 1.66]

2.3.3 Bacillus clausii

1

120

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.43, 1.47]

2.3.4 Bifidobacterium spp. plus Lactobacillus spp.

2

163

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.65, 1.92]

2.3.5 Bifidobacterium spp. plus Streptococcus spp.

1

474

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.64, 1.06]

2.4 Duration of hospitalisation from birth (days) Show forest plot

2

84

Mean Difference (IV, Random, 95% CI)

2.18 [‐13.84, 18.21]

2.4.1 Bifidobacterium spp. plus Lactobacillus spp.

2

84

Mean Difference (IV, Random, 95% CI)

2.18 [‐13.84, 18.21]
Figuras y tablas -
Comparison 2. Probiotics versus placebo or no probiotics (extremely preterm or extremely low birth weight infants)
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Comparison 3. Subgroup analysis by type of feeding

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

3.1 Necrotising enterocolitis Show forest plot

57

10918

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.46, 0.65]

3.1.1 Human milk only

9

1038

Risk Ratio (M‐H, Fixed, 95% CI)

0.30 [0.16, 0.57]

3.1.2 Mixed: human milk, formula, or both

44

9626

Risk Ratio (M‐H, Fixed, 95% CI)

0.58 [0.48, 0.70]

3.1.3 Formula only

4

254

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.16, 1.18]

3.2 All‐cause mortality Show forest plot

54

10484

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.66, 0.90]

3.2.1 Human milk only

9

1038

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.41, 1.00]

3.2.2 Mixed: human milk, formula, or both

42

9279

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.68, 0.95]

3.2.3 Formula only

3

167

Risk Ratio (M‐H, Fixed, 95% CI)

0.22 [0.04, 1.21]

3.3 Late‐onset invasive infection Show forest plot

49

9876

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.82, 0.97]

3.3.1 Human milk only

9

1038

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.58, 0.93]

3.3.2 Mixed: human milk, formula, or both

37

8614

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.84, 1.01]

3.3.3 Formula only

3

224

Risk Ratio (M‐H, Fixed, 95% CI)

0.41 [0.11, 1.49]

3.4 Duration of hospitalisation from birth (days) Show forest plot

24

5572

Mean Difference (IV, Fixed, 95% CI)

‐1.68 [‐3.08, ‐0.28]

3.4.1 Human milk only

5

418

Mean Difference (IV, Fixed, 95% CI)

‐4.09 [‐7.09, ‐1.09]

3.4.2 Mixed: human milk, formula, or both

17

5064

Mean Difference (IV, Fixed, 95% CI)

‐0.72 [‐2.34, 0.90]

3.4.3 Formula only

2

90

Mean Difference (IV, Fixed, 95% CI)

‐7.38 [‐14.96, 0.21]
Figuras y tablas -
Comparison 3. Subgroup analysis by type of feeding
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Comparison 4. Sensitivity analyses: trials at low risk of bias

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

4.1 Necrotising enterocolitis Show forest plot

17

4649

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.55, 0.89]

4.2 All‐cause mortality Show forest plot

17

4649

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.69, 1.07]

4.3 Late‐onset invasive infection Show forest plot

17

4649

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.78, 1.01]

4.4 Duration of hospitalisation from birth (days) Show forest plot

7

2838

Mean Difference (IV, Random, 95% CI)

‐2.45 [‐5.45, 0.56]

4.5 Neurodevelopmental impairment Show forest plot

2

913

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.76, 1.27]

4.6 Cerebral palsy Show forest plot

2

913

Risk Ratio (M‐H, Fixed, 95% CI)

1.14 [0.68, 1.92]

4.7 Visual impairment Show forest plot

2

913

Risk Ratio (M‐H, Fixed, 95% CI)

2.91 [0.12, 71.21]

4.8 Hearing impairment Show forest plot

2

913

Risk Ratio (M‐H, Fixed, 95% CI)

0.30 [0.09, 0.98]
Figuras y tablas -
Comparison 4. Sensitivity analyses: trials at low risk of bias
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