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. 2023 Aug 21;67(5):224–231. doi: 10.3345/cep.2023.00598

Table 2.

Studies of probiotics for neonatal diseasesa)

Study Description No. of studies and infants Results for effect of probiotic and/or synbiotic treatment vs. control
Systematic reviews and meta-analyses
 Sharif et al. [82] 2020 Included RCTs and quasi-RCTs of probiotics for infants born <32 weeks’ gestation and/ or <1,500 g 56 Trials with 10,812 infants NEC: RR, 0.54; 95% CI, 0.45–0.65
Mortality: RR, 0.76; 95% CI, 0.65–0.89
Late-onset invasive infection: RR, 0.89; 95% CI, 0.82–0.97
 Dermyshi et al. [80] 2017 Included RCTs and observational studies of probiotics for infants born <34 weeks’ gestation and <1,500 g 30 Trials with 8,622 infants and 14 observational studies with 13,779 infants Severe NEC: RR, 0.57; 95% CI, 0.47–0.70 in RCTs, RR, 0.51; 95% CI, 0.37–0.70 in observational studies
All-cause mortality: RR, 0.77; 95% CI, 0.65–0.92 in RCTs, RR, 0.71; 95% CI, 0.62–0.81 in observational studies
Late-onset sepsis: RR, 0.88; 95% CI, 0.80–0.97 in RCTs, RR, 0.81; 95% CI, 0.69–0.96 in observational studies
 Sawh et al. [81] 2016 Included RCTs of probiotics for infants born <37 weeks’ gestation and/or <2,500 g 42 Trials with 10,520 infants Severe NEC: RR, 0.53; 95% CI, 0.42–0.66
All-cause mortality: RR, 0.79; 95% CI, 0.68–0.93
Culture-proven sepsis RR, 0.88; 95% CI, 0.77–1.00
 Rao et al. [86] 2016 Included RCTs of probiotics for infants born <37 weeks’ gestation and/or <2,500 g 37 Trials with 9,416 infants Late-onset sepsis: RR, 0.86; 95% CI, 0.78–0.94
Large randomized, controlled trials
 Costeloe et al. [87] 2016 RCT of probiotics (Bifidobacterium breve) for infants born 23–30 weeks’ gestation 1,315 Infants Late-onset sepsis: RR, 0.97; 95% CI, 0.73–1.29
NEC ≥stage 2: RR, 0.93; 95% CI, 0.68–1.27
Mortality: RR, 0.93; 95% CI, 0.67–1.30
 Jacobs et al. [88] 2013 RCT of probiotics (Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis) for infants born <32 weeks’ gestation and <1,500 g 1,099 Infants Late-onset sepsis: RR, 0.81, 95% CI, 0.61–1.08
NEC: RR, 0.46, 95% CI, 0.23–0.93
Mortality: RR, 0.97, 95% CI, 0.58–1.62
 Panigrahi et al. [85] 2017 RCT of synbiotic (Lactobacillus plantarum plus fructooligosaccharide) for infants born ≥35 weeks and ≥2,000 g 4,556 Infants Sepsis and death: RR, 0.60; 95% CI, 0.48–0.74
Culture-positive sepsis: RR, 0.22; 95% CI, 0.09–0.53
Culture-negative sepsis: RR, 0.53; 95% CI, 0.30–0.92
Lower-respiratory tract infection: RR, 0.66; 95% CI, 0.51–0.88

RCT, randomized controlled trial; NEC, necrotizing enterocolitis; RR, relative risk; CI, confidence interval.

a)

Table includes a selection of relevant studies; not all published studies are included.