Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants .
There is insufficient data with regard to the benefits and potential adverse effects in the most at risk infants weighing less than 1000 grams at birth
BACKGROUND Necrotizing enterocolitis ( NEC ) and nosocomial sepsis are associated with increased morbidity and mortality in preterm infants .
Through prevention of bacterial migration across the mucosa , competitive exclusion of pathogenic bacteria , and enhancing the immune responses of the host , prophylactic enteral probiotics ( live microbial supplements ) may play a role in reducing NEC and the associated morbidity .
OBJECTIVES To compare the efficacy and safety of prophylactic enteral probiotics administration versus placebo or no treatment in the prevention of severe NEC or sepsis , or both , in preterm infants .
PLAIN LANGUAGE SUMMARY Probiotics for prevention of necrotizing enterocolitis in preterm infants Necrotizing enterocolitis ( NEC ) is a serious disease that affects the bowel of premature infants in the first few weeks of life .
Although the cause of NEC is not entirely known , milk feeding and bacterial growth play a role .
Probiotics ( dietary supplements containing potentially beneficial bacteria or yeast ) have been used to prevent NEC .
The politics of probiotics: probiotics, necrotizing enterocolitis and the ethics of neonatal research
There have been over twenty prospect i ve , r and omized trials of the use of probiotics to prevent  necrotizing enterocolitis ( NEC ) in premature babies . A Cochrane meta- analysis of 16 of the studies ( 1 ) including 2842 preterm infants , reported that ‘ enteral probiotics supplementation significantly reduced the incidence of severe NEC ( stage II or more ) ( typical RR , 0.35 ; 95 % CI , 0.24–0.52 ) and mortality ( typical RR , 0.40 ; 95 % CI , 0.27–0.60 ) with no evidence of harm . They concluded , ‘ Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants ’ . In a sensitivity analysis , including only the 4 highest quality studies , the results and conclusions were unchanged . For neonates born at < 32 weeks of gestation , the number needed to treat in order to prevent one NEC or one death is twenty . The risks of probiotics are minimal . A more recently published systematic review included several additional r and omized controlled trials , mostly published in the Chinese literature , and analysed a total of 20 publications and over 3800 preterm infants ; it came to similar conclusions as the Cochrane meta- analysis ( 2 ) . Probiotics are used in many European units but only rarely in North-America . In spite of the evidence , this safe and effective treatment for one of the most serious complications of prematurity has never been studied in the United States and perhaps never will . Probiotics will probably never be approved by the U.S. Food and Drug Administration ( FDA ) . Instead , they will remain in regulatory purgatory , neither approved nor unapproved , an evidence -based treatment that can not become the st and ard of care , a safe and effective treatment that is not on hospital formularies in the United States . Probiotics fall into a peculiar lacuna of the regulatory system . Most innovative treatments are either drugs or devices , and the regulatory pathways for evaluating and approving them are fairly well defined by federal law . The FDA has jurisdiction over both drugs and devices . Probiotics are neither drugs nor devices , and they are made by companies that generally market health products to the general public . In contrast , in Canada , probiotics are under the jurisdiction of the Natural Health Products Directorate ( NHPD ) which has rigorous requirements for quality control and detailed labelling . But the NHPD does not evaluate overtly medical cl aims made about a product . It has little experience dealing with either a product that could actually decrease major complications or save lives in a particularly fragile population where mortality is rather common . Probiotics are quite inexpensive to manufacture . People can even make them at home . They are in most yogurts . For pennies , some parents buy them for their preterm infants in health food stores . Some mothers have started adding probiotics to their breast milk . In these cases , the medical team can either be unaware a preterm infant is in fact receiving probiotics or tacitly not interfere with these parental initiatives . Given the low cost of probiotics and Articles in the series A Different View are edited by William Meadow ( wlm1@uchicago.edu ) . We encourage you to offer your own different view either in response to A Different View you do not fully agree with , or on an unrelated topic . Send your article to Dr. Meadow ( wlm1@uchicago.edu )
Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants .
There is insufficient data with regard to the benefits and potential adverse effects in the most at risk infants weighing less than 1000 grams at birth
BACKGROUND Necrotizing enterocolitis ( NEC ) and nosocomial sepsis are associated with increased morbidity and mortality in preterm infants .
Through prevention of bacterial migration across the mucosa , competitive exclusion of pathogenic bacteria , and enhancing the immune responses of the host , prophylactic enteral probiotics ( live microbial supplements ) may play a role in reducing NEC and the associated morbidity .
OBJECTIVES To compare the efficacy and safety of prophylactic enteral probiotics administration versus placebo or no treatment in the prevention of severe NEC or sepsis , or both , in preterm infants .
PLAIN LANGUAGE SUMMARY Probiotics for prevention of necrotizing enterocolitis in preterm infants Necrotizing enterocolitis ( NEC ) is a serious disease that affects the bowel of premature infants in the first few weeks of life .
Although the cause of NEC is not entirely known , milk feeding and bacterial growth play a role .
Probiotics ( dietary supplements containing potentially beneficial bacteria or yeast ) have been used to prevent NEC .