Efficacy of Probiotics Versus Placebo in the Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants: A Double-Blind Randomized Controlled Trial (original) (raw)
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Efficacy of probiotics to prevent necrotizing enterocolitis in low birth weight preterm neonates
The Professional Medical Journal
Objective: To compare the efficacy of probiotics in prevention of necrotizing enterocolitis (NEC) among low birth weight (LBW) preterm neonates. Study Design: Randomized controlled trial. Setting: Department of Pediatric Medicine, Unit-II, Services Hospital, Lahore. Period: September 2019 to February 2020. Material and Methods: A total of 260 LBW preterm neonates were enrolled. All the neonates were allocated to 2 groups with equal number of cases (130 in each group). Group-A was given probiotics whereas placebo was administered in Group-B. All the cases were admitted and follow ups were made up until 7th day. Occurrence of NEC was recorded among both groups. Results: Out of a total of 260 LBW preterm neonates, 142 (54.6%) were male and118 (45.4%) female. Overall, mean age was noted to be 1.48+0.50 days. Table-I shows that there was no statistical difference among neonates of both study groups in terms of age, gestational age and birth weight (p>0.05). Five (3.8%) neonates in Gro...
British Journal of Nutrition, 2017
The aim of the study was to determine whether routine probiotic supplementation (RPS) with Lactobacillus rhamnosus GG (LGG) or Lactobacillus acidophilus +Lactobacillus bifidum is associated with reduced risk of necrotising enterocolitis (NEC)≥Stage II in preterm neonates born at ≤32 weeks’ gestation. We conducted a retrospective cohort study on the effect of probiotic supplementation in very low birth weight infants in our neonatal unit by comparing two periods: before and after supplementation. The incidence of NEC≥Stage II, late-onset sepsis and all-cause mortality was compared for an equal period ‘before’ (Period I) and ‘after’ (Period II) RPS with LGG or L. acidophillus+L. bifidum. Multivariate logistic regression analysis was conducted to adjust for relevant confounders. The study population was composed of 261 neonates (Period I v. II: 134 v. 127) with comparable gestation duration and birth weights. In <32 weeks, we observed a significant reduction in NEC≥Stage II (11·3 v....
Effectiveness of Oral Probiotics in Prevention of Necrotizing Enterocolitis in Preterm Infants
Journal of Pharmaceutical Research International
Objective: To determine the efficacy of probiotics in the prevention of necrotizing enterocolitis in preterm infants. Materials And Methods: This randomized controlled trial was conducted at the paediatric department of CMH Muzaffarabad AJK. All preterm bottle and NG-fed neonates with an age of more than 24 hours and both genders were included. All the study subjects were divided into two groups randomly as group-A and group-B. Group-A was given probiotics (named Bifidobacterium prophylactically, hiflora, or gutcare, one sachet per day), while in Group-B probiotics were not given. All the cases were taken under observation. If they needed any critical or intensive care, they were excluded from the study and other treatments were given as per hospital protocol. Patients were followed for 7 days. Efficacy in both groups was measured in terms of no occurrence of NEC during one week. All related data was collected on a study proforma. Results: The average age of the neonates in the pro...
Nutrients
Background: Necrotizing enterocolitis (NEC) is a multifactorial disease, causing inflammation of the bowel. The exact root of NEC is still unknown, but a low weight and gestational age at birth are known causes. Furthermore, antibiotic use and abnormal bacterial colonization of the premature gut are possible causes. Premature neonates often experience feeding intolerances that disrupts the nutritional intake, leading to poor growth and neurodevelopmental impairment. Methods: We conducted a double-blind, placebo-controlled, randomized clinical trial to investigate the effect of a multi-strain probiotic formulation (LabinicTM) on the incidence and severity of NEC and feeding intolerances in preterm neonates. Results: There were five neonates in the placebo group who developed NEC (Stage 1A–3B), compared to no neonates in the probiotic group. Further, the use of probiotics showed a statistically significant reduction in the development of feeding intolerances, p < 0.001. Conclusion:...
International Journal of Medical Reviews, 2019
Introduction:Previous studies have shown that probiotics reduce the incidence of Necrotizing enterocolitis (NEC) and sepsis; while other studies have not shown a significant difference of NEC and sepsis incidence. To this date there is still no protocols or guidelines in regards to the use of routine probiotics in very low birth weight preterm infants. Method: The present study was a meta-analysis research. Up to date RCTs were reviewed to see the effectiveness of probiotics in order to prevent necrotizing enterocolitis. Studies were searched through PubMed, ProQuest, and Cochrane Library searching engines from 2009 to 2019. This meta-analysis was assessed according to PRISMA guidelines. The inclusion criteria were randomized controlled trials of probiotics for very low birth weight preterm babies; full text English articles; and having been published from 2009 to 2019. Results: The findings of this study reveal that the incidence of NEC in the probiotic group was significantly low...
Iranian Journal of Neonatology IJN, 2021
Objective: Given the contradictory results of studies on the efficacy of probiotics in reducing necrotizing enterocolitis and few studies in Iran, we decided to investigate the effect of probiotics on milk tolerance and prevention of necrotizing enterocolitis in preterm infants.Patients and Methods: This study was a randomized triple-blind clinical trial conducted on all preterm infants between 30 and 36 gestation weeks and body birth weight >1250 g hospitalized in neonatal intensive care unit at Bentolhoda hospital in Bojnurd. Then, 76 eligible neonates were randomly divided into two groups of receiving oral placebo (n=386) and BB care probiotic (n=3638). Information about early or late necrotizing enterocolitis (after 7 days of birth), types of necrotizing enterocolitis (grade I, II and III), length of hospital stayduration of hospitalization, time to reach complete oral nutrition, weight at discharge and milk tolerance based on hospital checklist were extracted.Results: In thi...
Jornal de Pediatria (Versão em Português), 2013
Objective: To elucidate the benefits of using probiotics in the prevention of necrotizing enterocolitis (NEC) and its complications in preterm newborns. Method: This was a systematic review of randomized controlled trials, which included studies retrieved from three databases (MEDLINE, Embase, and LILACS), using a combination of the terms (necrotizing enterocolitis) AND (probiotics). Results: 11 randomized trials were included, totaling 2,887 patients, 1,431 in the probiotic group and 1,456 in the control group. There was a reduction in the incidence of NEC (NNT = 25), overall death (NNT = 34), and neonatal sepsis (NNT = 34) in the probiotic group compared to the control group. Patients that received probiotic supplementation had lower food reintroduction time (p < 0.001) and hospitalization time (p < 0.001) when compared to those not receiving probiotics. There was no difference in mortality caused by NEC. Conclusion: In premature newborns, the use of probiotics is effective as a prophylaxis for NEC and its complications.
Probiotic Therapy for Prevention of Necrotizing Enterocolitis in Preterm Infants – A Review
Journal of Nutritional Health & Food Science, 2018
Purpose: Preterm infants are prone to systemic infections due to increased intestinal permeability to potentially pathogens resulting from immature intestinal function, frequent use of broad-spectrum antibiotics, delay in initiating enteral feeding, infection control procedures and sterilization of milk. Very Low Birth Weight infants, particularly Extremely Low Birth Weight infants are at higher risk due to abnormal pattern of colonization, which may contribute to the pathogenesis of neonatal Necrotizing Enterocolitis (NEC). Dietary intervention through probiotic supplementation is widely adopted for the prophylaxis of NEC and nosocomial infections throughout the world. Design/Methodology/Approach: This review paper is based upon systematic review of randomized controlled trials, metaanalyses, research papers and books related to the short and longterm administration of single or mixed probiotic cultures for the prevention of NEC only in preterm infants. Clinical trials and cohort studies concerning manipulation of the intestinal microbiota in premature infants are also included. Evidence based data published in the English language retrieved from three databases Pub Med, Science Direct and Cochrane Reviews, published in The Cochrane Library from 2000-2016, using a combination of key words like necrotizing enterocolitis, probiotics and preterm infants have been considered. Findings: All probiotic strains are not equally efficacious for preventing NEC and application of probiotic combinations may be advantageous. Due to heterogeneity of probiotic formulations exclusive administration of probiotics in premature infants is not recommended and should be introduced along with breast milk as routine clinical practice for neonatal health care. Originality/Value: Probiotic foods have been found effective in modulating gastrointestinal flora to prevent NEC but safety aspects must be evaluated prior to consideration of probiotic therapy for preterm infants and neonates.
Canadian Journal of Surgery, 2021
The effect of daily probiotics on the incidence and severity of necrotizing enterocolitis in infants with very low birth weight Background: Necrotizing enterocolitis remains a leading cause of morbidity and mortality in premature infants. The role of prophylactic probiotics in its prevention is unclear. This study evaluates the effect of routine probiotics on the incidence and severity of necrotizing enterocolitis in infants with very low birth weight in the neo natal intensive care unit. Methods: This retrospective cohort study compared infants cared for at a single institution before and after implementation of routine probiotic administration (2014-2018). Babies born after July 2016 received probiotics containing Bifidobac terium and Lactobacillus daily until 35 weeks corrected gestational age. Baseline charac teristics, necrotizing enterocolitis incidence and severity, infections, mortality, and length of stay were compared between groups. Results: Of the 665 infants included in the study, 310 received probiotics and 355 did not. The 2 groups did not differ with regard to gestational age, birth anthropo metrics, mode of delivery, comorbidities, and type of enteral feed. The incidence of necrotizing enterocolitis (Bell's stage 2 of 3) was similar between groups (4% v. 5%, p = 0.35), as was its severity (p = 0.10). In addition, there were no significant differ ences in mortality and length of stay between the groups. Significantly fewer infants receiving probiotics developed infections (27% v. 34%, p = 0.046), with the rate of urinary tract infections having the largest reduction. Conclusion: The routine use of Bifidobacterium and Lactobacillus probiotics in infants with very low birth weight did not significantly affect the incidence and severity of necrotizing enterocolitis. However, the use of probiotics was associated with fewer overall infections. Contexte : L'entérocolite nécrosante demeure une importante cause de morbidité et de mortalité chez les nourrissons prématurés. Le rôle des probiotiques prophylac tiques pour la prévention de l'entérocolite nécrosante reste à déterminer. Cette étude évalue l'effet de l'administration systématique de probiotiques sur l'incidence et la gravité de l'entérocolite nécrosante chez les nourrissons de très faible poids à la nais sance dans les unités de soins intensifs néonataux.