Probiotics In Preterm Neonates Research Articles

Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI.

The recent advisory issued by the United States Food and Drug Administration, cautioning against the routine administration of probiotics in preterm neonates, has sparked a lively debate within the scientific community. This commentary presents a perspective from members of the Special Interest Group on Gut Microbiota and Modifications within the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and other authors who contributed to the ESPGHAN position paper on probiotics for preterm infants, as well as representatives from the European Foundation for the Care of Newborn Infants. We advocate for a more nuanced and supportive approach to the use of certain probiotics in this vulnerable population, balancing the demonstrated benefits and risks.

Efficacy of Probiotics in Preterm Neonates in the Prevention of Necrotising Enterocolitis: A Randomised Controlled Tria

Introduction: The most frequent and dangerous gastrointestinal emergency in newborns is Necrotising Enterocolitis (NEC). A novel and promising strategy for preventing NEC is enterally given probiotics. Aim: To evaluate the efficacy of probiotics in preterm neonates in the prevention of NEC and to assess the time of achievement of full feeds and duration of Intensive Care Unit (ICU) stay. Materials and Methods: The present study was a parallel design single-centre randomised controlled trial, conducted in Neonatal Intensive Care Unit (NICU), Department of Paediatrics, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India, from November 2018 to April 2020. Total of 130 newborns were included after inclusion and exclusion criteria and were randomised into two groups: that is probiotic (group I, n=61) and non probiotic (group II, n=69) groups. The probiotic group was given probiotics with breastmilk and non probiotic group were given only breastmilk. Probiotic (Bifidobacterium breve M16V) 0.5 g was mixed with breastmilk and given twice daily till full feeds were reached. All neonates were followed-up on daily basis for the appearance of features of NEC. Other parameters like time of achievement of full feeds and duration of ICU stay were compared between the two groups. Descriptive and inferential statistical analysis was carried out in the present study. Results: Out of total sample, majority of babies belonged to the gestational age group of 30-33 weeks i.e., 30 (49.2%) in group I and 30 (43.5%) in group II. There were 29 (47.5%) females and 32 (52.5%) males in group I and, 32 (46.4%) females and 37 (53.6%) males in group II. There was a significant reduction of incidence of NEC (p-value=0.024) and earlier achievement of full feeds in the probiotic group (p-value=0.003) when compared to non probiotic group. The mean duration of ICU stay compared between the two groups was not statistically significant (p-value=0.366). Conclusion: Supplementation of probiotics to the preterm Low Birth Weight (LBW) babies helps in the reduction of incidence of NEC and also helps in earlier achievement of full feeds.

Probiotic Use in Preterm Neonates: A Review and Bibliometric Analysis

Abstract Background: Necrotizing enterocolitis (NEC) is a major health burden in peterm neonates with mortality rates between 21% and 50%. Prophylaxis is of primary importance as early diagnosis is hindered by the lack of specific signs and laboratory markers. Although probiotics have been routinely used for NEC prophylaxis in neonatal intensive care units around the world, clinical trials provide contradictory data, which fuels an ongoing debate about their efficacy and safety. Aims: To perform a review and bibliometric analysis on available clinical trials and case reports data on the safety and efficacy of probiotics in preterm neonates and identify relevant publication trends and patterns. Methods: A bibliometric search for publications on the topic was performed in the Web of Science Core Collection database and the resulting records analyzed in bibliometrix package in R. Results: Trends in publication activity, historical direct citation network relationships and keyword co-ocurrences were discussed in the context of the most recent therapeutic recommendations. Conclusion: We took a round view of the potential drawbacks to probiotic use in preterm infants and their possible solutions.

Effect of Probiotics on Enteral Milk Tolerance and Prevention of Necrotizing Enterocolitis in Preterm Neonates

Background: There is a dearth of studies in Iran on the efficacy of probiotics in reducing necrotizing enterocolitis (NEC), yielding contradictory results. Therefore, the present study aimed to assess the effect of probiotics on milk tolerance and the prevention of NEC in preterm neonates. Methods: This randomized triple-blind clinical trial study was conducted on all preterm neonates between 30 and 36 weeks gestation and birth weight >1250 g hospitalized in the neonatal intensive care unit (NICU) at Bentolhoda Hospital in Bojnurd, Iran. Thereafter, 76 eligible neonates were randomly assigned to two groups of oral placebo (n=38) and BB care probiotic (n=38). Subsequently, the following information was extracted based on the hospital checklist: early or late NEC (after 7 days of birth), types of NEC (grade I, II, and III), length of hospitalization, time to reach complete oral nutrition, weight at discharge, and milk tolerance. Results: In the current study, 52.6% and 47.4% of newborns in control and intervention groups were male, and no significant difference was observed between the two groups (P= 0.646). The incidence of NEC was significantly reduced among the intervention group. The feeding onset in the placebo group was significantly later, as compared to that in the intervention group. A significant difference was detected between the two groups in the length of hospital stay and weight gain during hospitalization. Conclusion: As evidenced by the obtained results, the administration of probiotics in preterm neonates might prevent NEC. Moreover, it can shorten the onset time of feeding and hospitalization duration.

Para-probiotics for Preterm Neonates-The Next Frontier.

Current evidence supports the use of probiotics in preterm neonates for prevention of necrotizing enterocolitis, mortality and late onset sepsis. Despite the strong evidence, the uptake of this intervention has not been universal due to concerns including probiotic sepsis, pro-inflammatory response and transmission of antibiotic resistance. Critically ill extremely preterm neonates with potentially compromised gut integrity are at higher risk of probiotic sepsis due to translocation. In most countries, probiotics are sold as food supplements with poor quality control. The traditional definition of probiotics as “live microorganisms” has been challenged as many experts have questioned the importance of viability in the context of the beneficial effects of probiotics. Paraprobiotics (ghost probiotics), are defined as non-viable microbial cells (intact or broken) or crude cell extracts (i.e., with complex chemical composition), which, when administered (orally or topically) in adequate amounts, confer a benefit on the human or animal consumer. Current evidence indicates that paraprobiotics could be safe alternatives to probiotics in preterm neonates. High-quality pre-clinical and clinical studies including adequately powered randomised controlled trials (RCTs) are warranted in preterm neonates to explore this new frontier.

Benefits of probiotics in preterm neonates in low-income and medium-income countries: a systematic review of randomised controlled trials

ObjectiveAlthough there is an overall reduction in underfive mortality rate, the progress in reducing neonatal mortality rate has been very slow. Over the last 20 years, preterm births have steadily...

The Prophylactic Role of Probiotics for Preterm Infants / Neonates

Necrotizing enterocolitis (NEC) is a major morbidity and cause of mortality in preterm neonates. Probiotics seem to have a beneficial role in preventing NEC, which is confirmed in meta-analyses of randomized controlled trials (RCTs). We therefore aimed to review and confirm the efficacy of probiotics in preterm neonates obtained in observational studies. To assess the effects of prophylactic probiotics in preterm infants.

Potential Benefits of Probiotics for Preterm Infants: A Review

Preterm infants are particularly susceptible to abnormal colonization and are therefore prone to systemic infections due to increased intestinal permeability to potentially pathogens. Abnormal pattern of colonization in pre-term infants may contribute to the pathogenesis of neonatal Necrotizing Enterocolitis (NEC), an acquired gastrointestinal (GI) disease associated with significant morbidity and mortality. Introduction of foods containing probiotic cultures may be advantageous as probiotics prevented gut colonization by abnormal flora. Endeavour has been made to explore the mechanism of gut colonization, suitability of breast milk for preterm infants, effect of administration of probiotics to preterm infants and its safety concerns. Human milk is also suitable for the management of premature infants but fortified breast milk may be a preferred choice and not the pooled pasteurized breast milk. Based upon Randomized Controlled Trials administration of probiotic in preterm infants with a birth weight >1000 g could be recommended due to significantly reduction in incidence of NEC and no systemic infections or serious adverse events was reported. Administration of probiotics in preterm neonates is recommended but further research is emerging for its routine application. Probiotic supplementation in preterm neonates exhibited good safety profile and did not show any side effects and can be recommended for preterm infants but not for extremely low birth weight (ELBW) infants [1, 2].

Probiotics for Preventing Late-Onset Sepsis in Preterm Neonates: A PRISMA-Compliant Systematic Review and Meta-Analysis of Randomized Controlled Trials.

The effect of probiotics on late-onset sepsis (LOS) in preterm neonates remains controversial. The authors systematically reviewed the literature to investigate whether enteral probiotic supplementation reduced the risk of LOS in preterm neonates in neonatal intensive care units.PubMed, Embase, and Cochrane Central Register of Controlled Trials were systematically searched for randomized controlled trials (RCTs) regarding the effect of probiotics in preterm neonates. The primary outcome was culture-proven bacterial and/or fungal sepsis. The Mantel–Haenszel method with random-effects model was used to calculate pooled relative risks (RRs) and 95% confidence intervals (CIs).Twenty-seven trials were included in our review, and 25 trials involving 6104 preterm neonates were statistically analyzed. Pooled analysis indicated that enteral probiotic supplementation significantly reduced the risk of any sepsis (25 RCTs; RR 0.83, 95% CI 0.73–0.94; I2 = 26%), bacterial sepsis (11 RCTs; RR 0.82, 95% CI 0.71–0.95; I2 = 0%), and fungal sepsis (6 RCTs; RR 0.57, 95% CI 0.41–0.78; I2 = 0%). This beneficial effect remains in very low birth weight infants (<1500 g) (19 RCTs; RR 0.86, 95% CI 0.75–0.97; I2 = 18%), but not in extremely low birth weight infants (<1000 g) (3 RCTs; RR 0.73, 95% CI 0.45–1.19; I2 = 53%). All the included trials reported no systemic infection caused by the supplemental probiotic organisms.Current evidence indicates that probiotic supplementation is safe, and effective in reducing the risk of LOS in preterm neonates in neonatal intensive care units. Further studies are needed to address the optimal probiotic organism, dosing, timing, and duration. High-quality and adequately powered RCTs regarding the efficacy and safety of the use of probiotics in extremely low birth weight infants are still warranted.

Prophylactic Probiotics for Preterm Infants: A Systematic Review and Meta-Analysis of Observational Studies

Background: Necrotizing enterocolitis (NEC) is a major morbidity and cause of mortality in preterm neonates. Probiotics seem to have a beneficial role in preventing NEC, which is confirmed in meta-analyses of randomized controlled trials (RCTs). We therefore aimed to review and confirm the efficacy of probiotics in preterm neonates obtained in observational studies. Objective: To assess the effects of prophylactic probiotics in preterm infants. Methods: A meta-analysis was performed searching PubMed, EMBASE, CENTRAL (the Cochrane Library) and www.clinicaltrials.gov. Reference lists of reviews of RCTs were also searched. Included studies were observational studies that enrolled preterm infants <37 weeks of gestational age. Trials were included if they administered any probiotics and measured at least one clinical outcome (e.g. NEC, all-cause mortality, sepsis or long-term development scores). Two authors extracted characteristics and outcomes from included studies. The Newcastle-Ottawa Scale was used for quality assessment. A random-effects meta-analysis model was used, and heterogeneity was assessed by the I² test. Results: We included 12 studies with 10,800 premature neonates (5,144 receiving prophylactic probiotics and 5,656 controls). The meta-analysis showed a significantly decreased incidence of NEC (risk ratio, RR = 0.55, 95% confidence interval, 95% CI, 0.39-0.78; p = 0.0006) and mortality (RR = 0.72, 95% CI, 0.61-0.85; p < 0.0001). Sepsis did not differ significantly between the two groups (RR = 0.86, 95% CI, 0.74-1.00; p = 0.05). Conclusions: Probiotic supplementation reduces the risk of NEC and mortality in preterm infants. The effect sizes are similar to findings in meta-analyses of RCTs. However, the optimal strain, dose and timing need further investigation.

Evidence-based guidelines for use of probiotics in preterm neonates.

BackgroundCurrent evidence indicates that probiotic supplementation significantly reduces all-cause mortality and definite necrotising enterocolitis without significant adverse effects in preterm neonates. As the debate about the pros and cons of routine probiotic supplementation continues, many institutions are satisfied with the current evidence and wish to use probiotics routinely. Because of the lack of detail on many practical aspects of probiotic supplementation, clinician-friendly guidelines are urgently needed to optimise use of probiotics in preterm neonates.AimTo develop evidence-based guidelines for probiotic supplementation in preterm neonates.MethodsTo develop core guidelines on use of probiotics, including strain selection, dose and duration of supplementation, we primarily used the data from our recent updated systematic review of randomised controlled trials. For equally important issues including strain identification, monitoring for adverse effects, product format, storage and transport, and regulatory hurdles, a comprehensive literature search, covering the period 1966-2010 without restriction on the study design, was conducted, using the databases PubMed and EMBASE, and the proceedings of scientific conferences; these data were used in our updated systematic review.ResultsIn this review, we present guidelines, including level of evidence, for the practical aspects (for example, strain selection, dose, duration, clinical and laboratory surveillance) of probiotic supplementation, and for dealing with non-clinical but important issues (for example, regulatory requirements, product format). Evidence was inadequate in some areas, and these should be a target for further research.ConclusionWe hope that these evidence-based guidelines will help to optimise the use of probiotics in preterm neonates. Continued research is essential to provide answers to the current gaps in knowledge about probiotics.