SEARCHMETA-ANALYSISpediatrics, clinical nutrition

meta-analysis·pediatrics, clinical nutrition, systematic review, meta-analysis·PMC10234253

Prebiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants

The Cochrane Database of Systematic Reviews · 4 authors, 3 centres

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TL;DR

This Cochrane systematic review and meta-analysis of seven randomized controlled trials (686 infants) found that enteral prebiotic supplementation in very preterm or very low birth weight infants may result in little or no difference in necrotising enterocolitis, all-cause mortality, or late-onset invasive infection before hospital discharge, but the evidence is of low certainty.

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This Cochrane systematic review included seven RCTs enrolling 705 very preterm or very low birth weight infants to assess enteral prebiotic supplementation versus placebo or no treatment. The evidence certainty was downgraded due to risk of bias in some trials and imprecision of effect estimates. All included trials were small, with a mean sample size of 100. The authors concluded that large, high-quality trials are needed to inform policy and practice.

STUDY TYPE

meta-analysis

SPECIALTY

pediatrics

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AI pipeline

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100% · A

ORIGINAL PAPER

PMC10234253

Prebiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants

The Cochrane Database of Systematic Reviews

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ABSTRACT

Abstract Background Dietary supplementation with prebiotic oligosaccharides to modulate the intestinal microbiome has been proposed as a strategy to reduce the risk of necrotising enterocolitis (NEC) and associated mortality and morbidity in very preterm or very low birth weight (VLBW) infants. Objectives To assess the benefits and harms of enteral supplementation with prebiotics (versus placebo or no treatment) for preventing NEC and associated morbidity and mortality in very preterm or VLBW infants. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Maternity and Infant Care database and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), from the earliest records to July 2022. We searched clinical trials databases and conference proceedings, and examined the reference lists of retrieved articles. Selection criteria We included randomised controlled trials (RCTs) and quasi‐RCTs comparing prebiotics with placebo or no prebiotics in very preterm (< 32 weeks' gestation) or VLBW (< 1500 g) infants. The primary outcomes were NEC and all‐cause mortality, and the secondary outcomes were late‐onset invasive infection, duration of hospitalisation since birth, and neurodevelopmental impairment. Data collection and analysis Two review authors separately evaluated risk of bias of the trials, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference (MD), with associated 95% confidence intervals (CIs). The primary outcomes of interest were NEC and all‐cause mortality; our secondary outcome measures were late‐onset (> 48 hours after birth) invasive infection, duration of hospitalisation, and neurodevelopmental impairment. We used the GRADE approach to assess the level of certainty of the evidence. Main results We included seven trials in which a total of 705 infants participated. All the trials were small (mean sample size 100). Lack of clarity on methods to conceal allocation and mask caregivers or investigators were potential sources of bias in three of the trials. The studied prebiotics were fructo‐ and galacto‐oligosaccharides, inulin, and lactulose, typically administered daily with enteral feeds during birth hospitalisation. Meta‐analyses of data from seven trials (686 infants) suggest that prebiotics may result in little or no difference in NEC (RR 0.97, 95% CI 0.60 to 1.56; RD none fewer per 1000, 95% CI 50 fewer to 40 more; low‐certainty evidence), all‐cause mortality (RR 0.43, 95% CI 0.20 to 0.92; 40 per 1000 fewer, 95% CI 70 fewer to none fewer; low‐certainty evidence), or late‐onset invasive infection (RR 0.79, 95% CI 0.60 to 1.06; 50 per 1000 fewer, 95% CI 100 fewer to 10 more; low‐certainty evidence) prior to hospital discharge. The certainty of this evidence is low because of concerns about the risk of bias in some trials and the imprecision of the effect size estimates. The data available from one trial provided only very low‐certainty evidence about the effect of prebiotics on measures of neurodevelopmental impairment (Bayley Scales of Infant Development (BSID) Mental Development Index score < 85: RR 0.84, 95% CI 0.25 to 2.90; very low‐certainty evidence; BSID Psychomotor Development Index score < 85: RR 0.24, 95% 0.03 to 2.00; very low‐certainty evidence; cerebral palsy: RR 0.35, 95% CI 0.01 to 8.35; very low‐certainty evidence). Authors' conclusions The available trial data provide low‐certainty evidence about the effects of prebiotics on the risk of NEC, all‐cause mortality before discharge, and invasive infection, and very low‐certainty evidence about the effect on neurodevelopmental impairment for very preterm or VLBW infants. Our confidence in the effect estimates is limited; the true effects may be substantially different. Large, high‐quality trials are needed to provide evidence of sufficient validity to inform policy and practice decisions. Keywords: Humans; Infant, Newborn; Enterocolitis, Necrotizing; Enterocolitis, Necrotizing/etiology; Enterocolitis, Necrotizing/prevention & control; Infant, Extremely Premature; Infant, Premature, Diseases; Infant, Premature, Diseases/etiology; Infant, Premature, Diseases/prevention & control; Infant, Very Low Birth Weight; Infections

CITATION EXPORT

Sahar Sharif, Sam J Oddie, Paul T Heath et al.. Prebiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. The Cochrane Database of Systematic Reviews. (2023). https://doi.org/10.1002/14651858.CD015133.pub2

AUTHORS

4 · 3 CENTRES

Sahar Sharif, Sam J Oddie, Paul T Heath, William McGuire

1Centre for Reviews and Dissemination, University of York, York, UK
2Bradford Neonatology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK
3Division of Child Health and Vaccine Institute, St. George's, University of London, London, UK