Prevention of necrotizing enterocolitis in neonates at risk by oral administration of monomeric IgG. Prevention of necrotizing enterocolitis in low-birth-weight infants by IgA-IgG feeding. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding in Preterm Infants: A Pilot Randomized Control Trial. Transfusion-related acute gut injury: necrotizing enterocolitis in very low birth weight neonates after packed red blood cell transfusion. Necrotizing enterocolitis prophylaxis: oral antibiotics and lyophilized enterobacteria vs oral immunoglobulins Efficacy of Probiotics Versus Placebo in the Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants: A Double-Blind Randomized Controlled Trial. Relationship of prolonged pharmacologic serum levels of vitamin E to incidence of sepsis and necrotizing enterocolitis in infants with birth weight 1,500 grams or less. Effect of oral probiotics supplementation in the prevention of necrotizing enterocolitis among very low birth weight preterm infants. Synbiotics for decreasing incidence of necrotizing enterocolitis among preterm neonates – a randomized controlled trial Early enteral feeding does not affect the incidence of necrotizing enterocolitis. Mortality of necrotizing enterocolitis expressed by birth weight categories. Oral lactoferrin to prevent nosocomial sepsis and necrotizing enterocolitis of premature neonates and effect on T-regulatory cells. Does fortification of pasteurized donor human milk increase the incidence of necrotizing enterocolitis among preterm neonates? A randomized controlled trial Oral gentamicin therapy in the prevention of neonatal necrotizing enterocolitis. A controlled double-blind trial. Oral probiotics: Lactobacillus sporogenes for prevention of necrotizing enterocolitis in very low-birth weight infants: a randomized, controlled trial Comparison of fast- and slow-feeding rate schedules to the development of necrotizing enterocolitis. Efficacy of Saccharomyces boulardii on necrotizing enterocolitis or sepsis in very low birth weight infants: a randomised controlled trial. A prospective controlled trial of oral kanamycin in the prevention of neonatal necrotizing enterocolitis. Efficacy of Bifidobacterium breve and Lactobacillus casei oral supplementation on necrotizing enterocolitis in very-low-birth-weight preterm infants: a double-blind, randomized, controlled trial. Comparison between killed and living probiotic usage versus placebo for the prevention of necrotizing enterocolitis and sepsis in neonates. Association of H2-Blocker Therapy and Higher Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial.
Necrotizing enterocolitis ( NEC ) represents one of the major causes of morbidity in low-birth-weight ( LBW ) preterm infants . This r and omized clinical trial evaluated the efficacy of an oral immunoglobulin preparation ( containing monomeric IgG in a concentration of 90 % ) in reducing the incidence of NEC in infants of LBW for whom maternal breast milk was not available . One hundred and thirty-two formula-fed newborns with a birth weight less than or equal to 1,500 g or a gestational age less than or equal to 34 weeks were r and omly studied . Five hundred mg of IgG pro die , subdivided into 5 doses , were given orally to the test group of 65 neonates during the first 2 weeks of life . Although the number of infants included in this group is limited , the results of this study are encouraging : during the first 15 days after birth , none of the subjects developed NEC , while 4 cases were confirmed in the untreated control group . It , therefore , seems possible that oral monomeric IgG administration may prevent the development of NEC in LBW infants In a r and omized clinical trial , we evaluated the efficacy of an oral immunoglobulin preparation ( 73 percent IgA and 26 percent IgG ) in reducing the incidence of necrotizing enterocolitis in infants of low birth weight for whom breast milk from their mothers was not available . A total of 434 infants weighing between 800 and 2000 g were eligible for entry in the study . Of these , 255 were withdrawn - 234 during the first week of the study because breast milk from their mothers became available ( 123 in the treatment group and 111 in the control group ) , and 21 because of violations of protocol or because breast milk became available after the first week . The duration of follow-up was 28 days . Among the infants for whom breast milk did not become available during the study , there were no cases of necrotizing enterocolitis among the 88 receiving oral IgA-IgG , as compared with six cases among the 91 control infants ( P = 0.0143 ) . Of the infants withdrawn from the study , two assigned to the control group had necrotizing enterocolitis . We conclude that the oral administration of IgA-IgG may prevent the development of necrotizing enterocolitis in low-birth-weight infants OBJECTIVE To test the hypothesis that normalizing the intestinal flora by administration of prophylactic probiotics would provide a natural defense , thereby reducing both the incidence and severity of  necrotizing enterocolitis ( NEC ) in preterm neonates . STUDY DESIGN Neonates < or = 1500 g birth weight were r and omized to either receive a daily feeding supplementation with a probiotic mixture ( Bifidobacteria infantis , Streptococcus thermophilus , and Bifidobacteria bifidus ; Solgar , Israel ) of 10(9 ) colony forming units (CFU)/day or to not receive feed supplements .  NEC was grade d according to Bell 's criteria . RESULTS For 72 study and 73 control infants , respectively , birth weight ( 1152 + /- 262 g vs 1111 + /- 278 g ) , gestational age ( 30 + /- 3 weeks vs 29 + /- 4 weeks ) , and time to reach full feeds  ( 14.6 + /- 8.7 days vs 17.5 + /- 13.6 days ) were not different . The incidence of NEC was reduced in the study group ( 4 % vs 16.4 % ; P=.03 ) . NEC was less severe in the probiotic-supplemented infants ( Bell 's criteria 2.3 + /- 0.5 vs 1.3 + /- 0.5 ; P=.005 ) . Three of 15 babies who developed NEC died , and all NEC-related deaths occurred in control infants . CONCLUSION Probiotic supplementation reduced both the incidence and severity of NEC in our premature neonatal population BACKGROUND Oropharyngeal administration of mother 's colostrum in early days has an immunoprotective effect in preterm infants . OBJECTIVES Our aim was to study the effect of oropharyngeal administration of mother 's milk ( OPAMM ) on decreasing the incidence of nosocomial sepsis . METHODS In a pilot prospect i ve r and omized study on preterm ( < 32 weeks gestation and 1500 g weight ) infants , we compared OPAMM practice ( applying 0.2 mL of mother 's colostrum or milk prior to gavage feeding until full oral feeding is reached ) with regular gavage feeding . The primary outcome was incidence of culture-proven nosocomial sepsis . Secondary outcomes included bacterial colonization of the gastrointestinal tract , feeding intolerance , time to reach full feeding , incidence of necrotizing enterocolitis , ventilator-associated pneumonia , duration of respiratory support , incidence of bronchopulmonary dysplasia ( BPD ) , length of hospital stay , and neonatal mortality . RESULTS The outcomes of 200 neonates ( 100 in each group ) were analyzed . OPAMM practice did not significantly reduce the incidence of culture proven nosocomial sepsis ( 8 % vs 13 % , P = 0.35 ) . Infants in the OPAMM group had a significantly lower growth of Klebsiella species in the oropharyngeal pouch , borderline lower incidence of ventilator-associated pneumonia , shorter duration of oxygen therapy , less episodes of feeding intolerance , reached full feeding earlier , and had a shorter length of hospital stay .  OPAMM practice did not affect the incidence of necrotizing enterocolitis , BPD , or neonatal mortality . CONCLUSION OPAMM prior to gavage feeding does not reduce the incidence of nosocomial sepsis but had beneficial effects on early achievement of feeding , and early hospital discharge in preterm very low-birth-weight infants OBJECTIVE This is a repeat cohort study in which we sought to determine whether an association of necrotizing enterocolitis ( NEC ) < 48 hours of a packed red blood cells ( PRBC ) transfusion was a prior sampling artifact . STUDY DESIGN All very low birth weight neonates with NEC Stage ≥ IIB admitted over an 18-month period were categorized for NEC : ( 1 ) < 48 hours after a PRBC transfusion ; ( 2 ) unrelated to the timing of PRBCs ; and ( 3 ) never transfused . RESULTS Eight hundred eighty-three admissions over 18 months were review ed ; 256 were very low birth weight that result ed in 36 NEC cases and 25 % were associated with PRBC ( n = 9 ) . PRBC-associated cases had lower birth weight , hematocrit , and rapid onset of signs ( < 5 hours ) . The timing of association of  PRBC transfusion and NEC differed from r and om , showing a distribution that was not uniform over time ( χ(2 ) = 170.7 , df = 40 ; P < .000001 ) consistent with the possibility of a causative relationship in certain cases of NEC . Current weight at onset of NEC did not differ ; however , the more immature the neonate the later the onset of NEC creating a curious centering of occurrence at a median of 31 weeks postconceptual age . CONCLUSIONS We conclude that PRBC-related NEC exists . Transfusion-related acute gut injury is an acronym we propose to characterize a severe neonatal gastrointestinal reaction proximal to a transfusion of PRBCs for anemia . The convergence at 31 weeks postconceptual age approximates the age of presentation of other O(2 ) delivery and neovascularization syndromes , suggesting a link to a generalized systemic maturational mechanism We conducted a prospect i ve r and omized trial to compare the efficacy of oral gentamicin versus oral IgA‐IgG for the prophylaxis of necrotizing enterocolitis ( NEC ) ;  200 newborns considered at high risk for NEC were assigned to group A ( oral IgA‐IgG , n= 100 ) or group B ( oral Gentamicin , n= 100 ) . NEC was diagnosed in 13 cases in group A and in 1 case in group B between the 3rd and 16th days of life . Surgical treatment was necessary in 3 cases ( 2 in group A ) . All infants survived . We conclude that oral gentamicin is more effective than oral IgA‐IgG in the prevention of NEC in infants at high risk OBJECTIVE To evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis ( NEC ) in preterm very low birth weight ( VLBW ) infants . STUDY DESIGN Ar and omized double blind controlled trial . PLACE AND DURATION OF STUDY The Paediatrics Department of Sylhet M.A.G. Osmani Medical College Hospital , Sylhet Bangladesh , from July 2012 to June 2015 . METHODOLOGY Preterm ( 28 - 33 weeks gestation ) VLBW ( birth weight 1000 - 1499 g ) neonates were enrolled . The study group was fed with probiotics once daily with breast milk from first feeding , and the control group with only breast milk without the addition of probiotics . Both the groups received other st and ard care . The primary outcome was the development of NEC ( stage II and III ) , categorized by modified Bell 's classification . RESULTS In 108 neonates , development of NEC was significantly lower in the study group than that of control group [ 1 ( 1.9 % ) vs. 6 ( 11.5 % ) ; p=0.044 ] . Age of achievement of full oral feeding was significantly earlier in the study group than that in the control group ( 14.88 ±3.15 and 18.80 ±4.32 days ; p < 0.001 ) . Duration of hospital stay was significantly short in the study group compared to the control group ( 15.82 ±2.94 days vs. 19.57 ±4.26 days ; p < 0.001 ) . CONCLUSION Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight . It is also associated with faster achievement of full oral feeding and short duration of hospital stay The incidence of culture-proven neonatal sepsis and necrotizing enterocolitis ( NEC ) in preterm infants maintained at pharmacologic ( mean 5.1 mg/dL + /- 1.45 SD ) serum vitamin E levels for long periods was prospect ively studied as part of a double-masked clinical trial of the effect of prophylactic vitamin E v placebo treatment on the development and course of retinopathy of prematurity ( ROP ) . Within a few days of birth , 914 preterm infants were enrolled in the study ; 545 ( 275 placebo-treated infants , 270 vitamin E-treated infants had birth weight of 1,500 g or less . A significant difference in incidence of neonatal sepsis ( 17 placebo-treated infants , 37 vitamin E-treated infants ) and NEC ( 18 placebo-treated infants , 32 vitamin E-treated infants ) was observed among infants who had been treated for eight or more days and who had developed neither sepsis nor NEC before that time . The association of vitamin E treatment with increased incidence of disease was much higher with sepsis than with NEC . The most likely reason for these observations is a pharmacologic serum vitamin E-related decrease in oxygen-dependent intracellular killing ability which results in a decreased resistance to infection in preterm infants . The data suggest that , if this occurs , it is clinical ly significant only in the more immature infants . In view of the known variability of absorption of oral vitamin E and the association between high serum vitamin E levels and increased incidence of sepsis and late-onset NEC reported here , it can be concluded that serum vitamin E levels must be monitored when supplemental vitamin E is administered to premature infants , especially those with birth weight 1,500 g or less . The risk-benefit ratio of long-term treatment using vitamin E at high serum levels should be clearly assessed BACKGROUND Necrotizing enterocolitis ( NEC ) is the most serious gastrointestinal problem in very low birth weight preterm infants . Multiple risk factors activate the inflammatory cascade leading to high expressions of pro-inflammatory mediators causing bowel injury in NEC . The anti-inflammatory effect of probiotics is due to the inhibition and reduction of inflammatory signal in intestinal epithelium . OBJECTIVE To evaluate the efficacy of probiotics supplementation in the prevention of NEC among very low birth weight preterm infants . STUDY DESIGN A prospect i ve r and omized controlled trial . MATERIAL AND METHOD All preterm infants with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1,500 grams admitted in neonatal care unit , Queen Sirikit National Institute of Child Health during June 1st , 2012 and January 31th , 2013 were enrolled in this study . They were r and omized into two groups , study and control group . Infants in the study group were fed Infloran ( Lactobacillus acidophilus 1 x 10(9 ) and Bifidobacterium bifidum 1 x 10(9 ) organisms ) dose 125 mg/kg/dose twice a day with breast milk or premature formula from the start of feeding until 6 weeks or discharge . Infants in the control group were fed with either breast milk or premature formula alone . The primary outcome was NEC stage ≥ 2 . RESULTS Sixty infants completed the study , 31 infants in the study group and 29 infants in the control group . The baseline characteristic data of infants were similar except for more males in the present study group . Incidence of NEC stage ≥ 2 were similar in both the groups , 3.2 vs. 3.4 % ( p = 0.74 ) . There were no deaths during the study period . Days to reach full feeding , 150 ml/kg/day , were no differences between the two groups , 12.03 ± 5.49 days vs. 13.76 ± 8.25 days ( p = 0.31 ) . No adverse effects such as sepsis , flatulence or diarrhea were noted . CONCLUSION In this study , there was no difference in incidence of NEC stage ≥ 2 between the two groups . No adverse effects of probiotics supplementation were observed Abstract Objective : To study the effect of synbiotics in reducing incidence and severity of necrotizing enterocolitis ( NEC ) among preterm neonates . Methods : This r and omized controlled trial conducted in a tertiary care teaching hospital , south India , included 220 enterally fed preterm neonates who were r and omized to receive either synbiotics or no intervention .  The synbiotic contained Lactobacillus , Bifidobacterium and fructo-oligosaccharide . The demographic parameters , risk factors for NEC and outcome including incidence of NEC , its severity , sepsis and mortality were evaluated . Results : Multiple pregnancies , preeclampsia and prolonged rupture of membranes were important maternal characteristics . The average birth weight and gestational age of the preterm neonates was 1.4 kg and 31 weeks , respectively . There was a 50 % reduction in the incidence of NEC of all stages in preterm infants who received synbiotics compared to the non-intervention group ( 7.4 % versus 14.5 % ) . Administration of synbiotics did not reduce the severity of NEC , sepsis or mortality . Conclusion : Enteral supplementation of synbiotics along with breastmilk results in a tendancy to decrease the incidence of NEC among preterm neonates To begin to determine the optimal time for initiating enteral feedings , 34 sick , very low birth weight infants were prospect ively selected from all neonates of less than 1,500 g ( N = 116 ) and r and omly divided into two groups . Infants were fed either on day 1 ( early ) or 7 ( late ) of life , according to a feeding protocol which included parenteral nutrition and a scheduled progression from sterile water to 2.5 % dextrose , half-strength , and finally full-strength formula over seven days . The incidence of necrotizing enterocolitis and subsequent hospital course were compared . Initiating enteral feedings on day 1 did not significantly increase the incidence of necrotizing enterocolitis , produce a clustering of cases , or induce an earlier onset of necrotizing enterocolitis . The overall incidence of necrotizing enterocolitis in sick , very low birth weight neonates was 29 % ( 5/17 ) and 35 % ( 6/17 ) in the early and late groups , respectively , compared with 4.2 % ( 2/47 ) in minimally sick , very low birth weight neonates . No significant differences between groups were seen in obstetrical complications , birth weight , gestational age , Apgar scores , presence of patent ductus arteriosus or intraventricular hemorrhage , use of umbilical catheterization , and respiratory or oxygen requirements . Infants fed enterally from day 1 did show a significantly higher energy and protein intake during the second week of life . These data show that providing dilute , early enteral calories does not adversely affect the incidence of necrotizing enterocolitis PURPOSE Low birth weight is the most important risk factor for developing necrotizing enterocolitis ( NEC ) . We aim ed to establish birth weight-based benchmarks for in-hospital mortality in neonates with NEC . METHODS Five hundred eleven centers belonging to the Vermont Oxford Network prospect ively evaluated 71,808 neonates with birth weight of 501 to 1500 g between January 2005 and December 2006 . The primary outcome variable was in-hospital mortality . RESULTS Birth weight was divided into 4 categories by 250-g increments . The NEC risk ( P < .001 ) and mortality ( P < .001 ) decreased with higher birth weight category . Necrotizing enterocolitis was associated with a significant odds ratio for death for each category ( P < .001 ) . Across groups , the odds ratio for NEC mortality increased with higher birth weight category ( category 1 = 1.6 vs category 4 = 9.9 ; P < .001 ) . CONCLUSION The in-hospital mortality rate of neonates with NEC remains high and is significantly related to birth weight category . Although the risk and absolute mortality of NEC decrease with higher birth weight , the odds ratios indicate that NEC has a relatively greater impact upon mortality at higher birth weight . These data afford birth weight-based mortality benchmarks that may be useful in assessing single center NEC outcomes and facilitating comparisons between centers OBJECTIVE Lactoferrin ( LF ) is effective in the prevention of sepsis in very low birth weight ( VLBW ) neonates .  T-regulatory cells ( Tregs ) are important subsets of T lymphocytes that control pathogen-specific immune responses and are essential for intestinal immune homoeostasis . The aim of the present study is to determine whether oral LF at a dosage of 200 mg/d reduces nosocomial sepsis episodes and necrotizing enterocolitis ( NEC ) in premature infants and to evaluate the possible effects of LF on Treg levels . STUDY DESIGN In this prospect i ve , placebo-controlled , double-blind , r and omized trial , infants either VLBW or born before 32 weeks were assigned to receive either placebo ( n = 25 ) , or 200 mg LF ( n = 25 ) daily throughout hospitalization . Episodes of culture proven nosocomial sepsis and NEC were recorded . The level of FOXP3 + CD4 + CD25hi lymphocytes was studied by flow cytometry at birth and discharge . A third comparison was made with healthy term neonates ( n = 16 ) . RESULTS Fewer sepsis episodes were observed in LF-treated infants ( 4.4 vs. 17.3/1,000 patient days , p = 0.007 ) with none developing NEC , without statistical significance . Treg levels at birth and discharge were similar , while preterm infants showed significantly lower levels than term controls . However , individual increases in Treg levels were higher in the LF group . CONCLUSION LF prophylaxis reduced nosocomial sepsis episodes . Treg levels in preterm infants were lower than in term infants and an increase of Treg levels under LF prophylaxis was observed . Increase in Treg levels can be the mechanism for protective effects of LF on nosocomial sepsis Abstract Objective : To compare the effect of fortified pasteurized donor human milk ( PDHM ) versus unfortified PDHM on the incidence of necrotizing enterocolitis ( NEC ) and immediate outcome among preterm neonates . Methods : This r and omized controlled trial ( RCT ) conducted in a tertiary care teaching hospital , south India included 80 healthy preterm neonates r and omized to two groups ( Group A and B ) . Neonates in Group A and B were fed with fortified PDHM and unfortified PDHM , respectively . Neonates in both groups were managed uniformly as per st and ard NICU protocol . The primary outcome was the incidence of NEC and the secondary outcomes included severity of NEC , incidence of sepsis , mortality , duration of hospital stay , number of days to reach full enteral feeds and weight gain . Neonates were followed up for 28 days or discharge whichever was earlier . Results : The baseline maternal and neonatal characteristics in both groups were comparable . There was no increase in incidence of NEC in fortified PDHM group compared to unfortified PDHM group ( 2.5 versus 7.5 % , p = .31 ) . Severity of NEC , incidence of sepsis , mortality , duration of hospital stay , number of days to reach full enteral feeds and weight gain were also similar in both groups . Conclusions : St and ard fortification of PDHM does not increase the incidence of NEC among preterm neonates The value of prophylactic oral gentamicin sulfate therapy in the prevention of necrotizing enterocolitis ( NEC ) was evaluated in a group of 42 high-risk neonates over a four-month period in a r and omized , double-blind controlled trial . Twenty babies in the treatment group received 2.5 mg/kg of gentamicin sulfate every six hours for one week after birth , and 22 babies received dextrose- and -water placebo in an equivalently small volume . None of the 20 gentamicin-treated babies developed NEC . Four of the control babies did . Two of these babies died , and their diagnosis was pathologically confirmed . This difference in the incidence of NEC between the treatment and control group was significant at the .05 level . These results support the prophylactic use of orally given gentamicin for selected babies at high risk for NEC  , particularly those born prematurely and those who have a history of perinatal asphyxia or umbilical artery catheterization or both . Continued surveillance for changes in antimicrobial sensitivity patterns is recommended Background / Objective : The identification of probiotic species involved in gut homeostasis and their potential therapeutic benefits have led to an interest in their use for preventing necrotizing enterocolitis ( NEC ) . Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials . Lactobacillus sporogenes has not been used in the prevention of NEC in very low-birth weight infants yet . The objective of this study was to evaluate the efficacy of orally administered L sporogenes in reducing the incidence and severity of NEC in very low-birth weight ( VLBW ) infants . Subjects/ Methods : A prospect i ve , blinded , r and omized controlled trial was conducted in preterm infants with a gestational age of <33 weeks or birth weight of < 1500 g. VLBW infants who survived to start enteral feeding were r and omized into two groups The infants in the study group were given L. sporogenes with a dose of 350 000 000 c.f.u . added to breast milk or formula , once a day , starting with the first feed until discharged . The infants in the control group were fed without L. sporogenes supplementation . The primary outcome measurement was death or NEC ( Bell 's stage ⩾2 ) . Results : A total of 221 infants were studied : 110 in the study group and 111 in the control group . There was no significant difference in the incidence of death or NEC between the groups . Feeding intolerance was significantly lower in the probiotics group than in the control group ( 44.5 % ( n : 49 ) vs 63.1 % ( n : 70 ) , respectively ; P=0.006 ) . Conclusions : L. sporogenes supplementation at the dose of 350 000 000 c.f.u/day is not effective in reducing the incidence of death or NEC in VLBW infants , however , it could improve the feeding tolerance NECROTIZING ENTEROCOLITIS is a serious disorder of the newborn infant that rarely occurs before the institution of oral feedings . ' -3 Various feeding practice s have been shown to be important in the pathogenesis of the disease . Low-birth-weight infants fed a hyperosmolar , 650 mOsm/1 , elemental formula  have an increased incidence of NEC when compared to low-birth-weight infants fed a cow milk formula . 4 It has also been suggested that cow milk feedings themselves or the exclusion of breast milk from the diet of small newborn infants may be predisposing factors ? The quantity of feedings in the first weeks of life may also be important , and Krouskop and associates ~ have associated the development of NEC with early institution of oral feedings . In another retrospective study , however , there were no differences between the volume of formula offered NEC patients at the time symptoms developed and infants of similar size and age who did not develop NEC . 1 Conflicting opinions therefore exist regarding the relationship of oral feeding to the development of NEC ; there have been no r and omized , prospect i ve , clinical trials dealing with this issue . The purpose s of this paper are to report the relationship of different feeding practice s in the Intermountain Newborn Intensive Care Center to the incidence of NEC , and the results of a prospect i ve controlled investigation comparing two different feeding schedules in low-birth-weight infants BACKGROUND Probiotics have strain specific effects and the effects of fungi in preventing diseases in preterm infants have been investigated poorly . Saccharomyces boulardii is a yeast which acts both as a probiotic and a polyamine producer . AIM The objective of this study was to investigate the efficacy of S. boulardii in preventing necrotizing enterocolitis ( NEC ) or sepsis in very low birth weight infants . STUDY DESIGN AND SUBJECTS A prospect i ve , double blind , placebo controlled trial was conducted in preterm infants ( ≤ 32 GWs , ≤ 1500 g birth weight ) . They were r and omized either to receive feeding supplementation with S. boulardii 50 mg/kg every 12 h or placebo , starting with the first feed until discharged . OUTCOME MEASURES Necrotizing enterocolitis ( NEC ) or sepsis and NEC or death . RESULTS Birth weight and gestational age of the study ( n = 104 ) and the control ( n = 104 ) groups were 1126 ± 232 vs 1162 ± 216 g and 28.8 ± 2.2 vs 28.7 ± 2.1 weeks , respectively . Neither the incidence of stage ≥ 2 NEC or death nor stage ≥ 2 NEC or late onset culture proven sepsis was significantly lower in the study group when compared with the control group ( 9.6 % vs 7.7 % , p = 0.62 ; 28.8 % vs 23 % , p = 0.34 ) . Time to reach 100 mL/kg/day of enteral feeding ( 11.9 ± 7 vs 12.6 ± 7 days , p = 0.37 ) was not different between the groups . CONCLUSIONS Saccharomyces boulardii did not decrease the incidence of NEC or sepsis Alimentary kanamycin , 15 mg/kg/day , was given as prophylaxis for  neonatal necrotizing enterocolitis  in a prospect i ve study . Newborn infants of less than 1,500 gm birth weight who survived until initiation of alimentary nutrition at the University of Florida Neonatal Intensive Care Unit were admitted to a control or study group based on the last digit of the hospital number .  Alimentary kanamycin was not absorbed ; all blood levels determined were less than 0.5 μg/ml . The two groups had similar gestational ages , birth weights , severity of neonatal illness , and frequency of therapeutic procedures . In the study group of 35 infants , none developed neonatal necrotizing enterocolitis , whereas five cases occurred in the 40 control infants ( p=0.038 ) BACKGROUND Probiotics are used for the prevention of necrotizing enterocolitis ( NEC ) because of their positive effects on intestinal motor function , modulation of inflammatory response , and mucosal barrier function . OBJECTIVE The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage ≥ 2 by the criteria of Bell in very-low-birth-weight preterm infants . DESIGN A double-blind , r and omized , controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth . The intervention group was composed of 119 infants who received human milk with probiotic supplementation ( B. breve and L. casei )  and a control group of 112 infants who received human milk containing no probiotics .  The primary outcome was the occurrence of NEC stage ≥ 2 as defined by Bell 's modified criteria . RESULTS Four confirmed cases of NEC stage ≥ 2 by Bell 's criteria occurred only in the control group . CONCLUSIONS Oral supplementation of B. breve and L. casei reduced the occurrence of NEC ( Bell 's stage ≥ 2 ) . It was considered that an improvement in intestinal motility might have contributed to this result . This trial was registered at www.is rct in.org as number 67165178 ( International St and ard R and omized Controlled Trial ) UNLABELLED The aim of the study is to compare the role of killed ( KP ) Lactobacillus acidophilus with living ( LP ) in reducing incidence of sepsis ( NS ) and necrotizing enterocolitis ( NEC ) in neonates . R and omized double blind placebo study , included 150 neonates admitted to NICU at day 1 , sixty received oral ( LP ) and 60 received ( KP ) and 30 received placebo .  One gram of stools was collected on admission , at day 7 , at end of the study , as well as on suspected NEC or NS and was sent for culture . RESULTS LP and KP were preventive factors for NEC with absolute risk reduction ( AAR ) 16 , 15 % , respectively and 18 % for NS compared to placebo .  Incidence of NEC and NS did not differ significantly between neonates supplemented with LP and those with KP . Preterm neonates supplemented with KP showed significantly lower incidence of NEC compared to placebo , while incidence of NS showed no significant difference between both groups . There is significant reduction in NS and NEC among neonates with positive Lactobacillus colonization of gut compared to those none colonized at day 7 ( 27.9 vs. 85.9 % , 0 vs. 7.8 % ) and at day 14 ( 48.7 vs. 91.7 % for NS and 0 vs. 20.8 % for NEC ) . Overall comparison between the three groups showed statistical significant reduction in the incidence of NEC . Present conclusions are that early gut colonization with beneficial bacteria lowers the incidence of NEC and NS . KP retained similar benefits to live bacteria OBJECTIVE . We sought to determine if an association exists between the use of histamine-2 receptor ( H2 ) blockers and the incidence of  necrotizing enterocolitis ( NEC ) in infants of 401 to 1500 g in birth weight . STUDY DESIGN . Data from the National Institute of Child Health and Human Development Neonatal Research Network very low birth weight ( 401–1500 g ) registry from September 1998 to December 2001 were analyzed . The relation between the diagnosis of NEC ( Bell stage II or greater ) and antecedent H2-blocker treatment was determined by using case-control methodology . Conditional logistic regression was implemented , controlling for gender , site of birth ( outborn versus inborn ) , Apgar score of < 7 at 5 minutes , and postnatal steroids . RESULTS . Of 11072 infants who survived for at least 12 hours , 787 ( 7.1 % ) developed NEC ( 11.5 % of infants 401–750 g , 9.1 % of infants 751–1000 g , 6.0 % of infants 1001–1250 g , and 3.9 % of infants 1251–1500 g ) . Antecedent H2-blocker use was associated with an increased incidence of NEC ( P < .0001 ) . CONCLUSIONS . H2-blocker therapy was associated with higher rates of NEC , which is in agreement with a previous r and omized trial of acidification of infant feeds that result ed in a decreased incidence of NEC . In combination , these data support the hypothesis that gastric pH level may be a factor in the pathogenesis of NEC IMPORTANCE NEC is a common and severe complication in premature neonates , particularly those with very-low-birth-weight ( VLBW , < 1500 g at birth ) .  Probiotics including lactobacillus rhamnosus GG ( LGG ) proved effective in preventing NEC in preterm infants in several RCTs . OBJECTIVE Lactoferrin , a mammalian milk glycoprotein involved in innate immune host defences , can reduce the incidence of NEC in animal models , and its action is enhanced by LGG . We tried to assess whether bovine lactoferrin ( BLF ) , alone or with the probiotic LGG , has a similar effect in human infants , something that has not yet been studied . DESIGN An international , multicenter , r and omized , double-blind , placebo-controlled trial conducted from October 1st , 2007 through July 31st , 2010 . SETTING Thirteen Italian and New Zeal and tertiary neonatal intensive care units . PARTICIPANTS 743 VLBW neonates were assessed until discharge for development of NEC . INTERVENTION Infants were r and omly assigned to receive orally either BLF ( 100 mg/day ) alone ( group LF ; n = 247 ) or with LGG ( at 6 × 10(9 ) CFU/day ; group BLF + LGG ; n = 238 ) , or placebo ( Control group ; n = 258 ) from birth until day 30 of life ( 45 for neonates < 1000 g at birth ) . MAIN OUTCOME MEASURES ≥ stage 2 NEC ; death- and /or-≥ stage 2 NEC prior to discharge . RESULTS Demographics , clinical and management characteristics of the 3 groups were similar , including type of feeding and maternal milk intakes . NEC incidence was significantly lower in groups BLF and BLF + LGG [ 5/247 ( 2.0 % ) ] and 0/238 ( 0 % ) , respectively ] than in controls [ 14/258 ( 5.4 % ) ] ( RR = 0.37 ; 95 % CI : 0.136 - 1.005 ; p = 0.055 for BLF vs. control ; RR = 0.00 ; p < 0.001 for BLF + LGG vs. control ) . The incidence of death- and /or-NEC was significantly lower in both treatment groups ( 4.0 % and 3.8 % in BLF and BLF + LGG vs. 10.1 % in control ; RR = 0.39 ; 95 % CI : 0.19 - 0.80 ; p = 0.008 . RR = 0.37 ; 95 % CI : 0.18 - 0.77 ; p = 0.006 , respectively ) . No adverse effects or intolerances to treatment occurred . CONCLUSIONS AND RELEVANCE Compared with placebo , BLF supplementation alone or in combination with LGG reduced the incidence of ≥ stage 2 NEC and of death- and /or ≥ stage 2 NEC in VLBW neonates . BLF might be a promising strategy to prevent NEC in NICU setting s. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical setting s. TRIAL REGISTRATION IS RCT N53107700-http://www.controlled-_trials.com/IS RCT N53107700
Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC .
There are no r and omized controlled trials of oral IgA alone for the prevention of NEC
BACKGROUND Necrotizing enterocolitis ( NEC ) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period .
There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa .
OBJECTIVES To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight ( or both ) neonates .