***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: Background Sepsis is an important cause of neonatal death and perinatal brain damage , particularly in preterm infants . While effective antibiotic treatment is essential treatment for sepsis , resistance to antibiotics is increasing . Adjuvant therapies , such as intravenous immunoglobulin , therefore offer an important additional strategy . Three Cochrane systematic review s of r and omised controlled trials in nearly 6,000 patients suggest that non-specific , polyclonal intravenous immunoglobulin is safe and reduces sepsis by about 15 % when used as prophylaxis but does not reduce mortality in this situation . When intravenous immunoglobulin is used in the acute treatment of neonatal sepsis , however , there is a suggestion that it may reduce mortality by 45 % . However , the existing trials of treatment were small and lacked long-term follow-up data . This study will assess reliably whether treatment of neonatal sepsis with intravenous immunoglobulin reduces mortality and adverse neuro-developmental outcome . Methods and design A r and omised , placebo controlled , double blind trial . Babies with suspected or proven neonatal sepsis will be r and omised to receive intravenous immunoglobulin therapy or placebo . Eligibility criteria Babies must be receiving antibiotics and have proven or suspected serious infection AND have at least one of the following : birthweight less than 1500 g OR evidence of infection in blood culture , cerebrospinal fluid or usually sterile body fluid OR be receiving respiratory support via an endotracheal tube AND there is substantial uncertainty that intravenous immunoglobulin is indicated . Exclusion criteria Babies are excluded if intravenous immunoglobulin has already been given OR intravenous immunoglobulin is thought to be needed OR contra-indicated . Trial treatment Babies will be given either 10 ml/kg of intravenous immunoglobulin or identical placebo solution over 4–6 hours , repeated 48 hours later . Primary outcome Mortality or major disability at two years , corrected for gestational age . Data collection Data will be collected at discharge from hospital and at 2 years of age ( corrected for gestation ) using a parental question naire and a health status question naire completed during a face-to-face follow-up appointment with the child 's paediatrician . Trial registration Current Controlled Trials ISCRTN94984750 In a prospect i ve double‐blind study , st and ard intravenous immunoglobulin ( IVIG ) was compared with an IgM‐enriched IVIG in the treatment of neonatal sepsis . The two treatment groups were also compared with matched controls . One hundred and thirty babies ( 65 in each group ) ranging from 0 to 24 days old , 480 to 4200 g in weight and born between 24 and 42 weeks of gestation who had , or were suspected of having , sepsis were given either st and ard IVIG or IgM‐enriched IVIG ( 250 mg/kg per day ) for 4 days in addition to supportive and antibiotic therapy . A further 65 babies who received similar supportive , antibiotic and fluids but not IVIG were used as matched  controls . Mortality from infection in ‘ culture proven sepsis ’ was 3/44 ( 6·8 % ) in the IgM‐enriched IVIG group , 6/42 ( 14·2 % ) in the st and ard IVIG group , and 11/43 ( 25·5 % ) in the control group ( P = 0·017 , IgM versus control , P = 019 st and ard IVIG versus control ) . There was no statistical difference in the outcome between the two immunoglobulin therapy groups ( P = 0·25 ) . The study indicates that IVIG improves outcome in neonatal sepsis when used as an adjunct to supportive and antibiotic therapy , but larger studies are required to confirm this OBJECTIVE To evaluate the effect of pentaglobin treatment on clinical and laboratory parametres and the major morbidities in very low birthweight neonates with nosocomial sepsis before and after pentaglobin treatment . METHODS The prospect i ve interventional study was conducted from January 1 to December 31 , 2010 , at the neonatal intensive care unit ( NICU ) of the Bakirköy Dr. Sadi Konuk Training and Research Hospital , Istanbul , Turkey .  Pentaglobin was initiated on the day of diagnosis of nosocomial sepsis to 13 pre-term neonates as a support therapy in addition to antibiotics ; 5 ml/kg per day of pentaglobin was infused over a 4-hour period on 3 consecutive days . Clinical and laboratory parametres and major morbidities were recorded before and after pentaglobin treatment and compared using NCSS software . RESULTS Of the total , 8 ( 66 % ) were females and 5 ( 40 % ) males .  Following pentaglobin therapy , the immature-to-total neutrophil ratio and C-reactive protein levels were significantly decreased , and the capillary pH and base excess were significantly increased ( p < 0.05 ) . The axillary temperature , non-invasive blood pressure , haemoglobin , leukocyte , and thrombocyte values did not significantly differ before and after treatment ( p > 0.05 ) . Coagulase-negative staphylococci ( n = 3 ; 23 % ) , Klebsiella pneumoniae ( n = 2 ; 15.3 % ) , and Pseudomonas aeruginosa ( n = 1 ; 7.7 % ) were identified in blood cultures . The presence of intraventricular haemorrhages , necrotising enterocolitis , periventricular leukomalacia , and patent ductus arteriosus was not changed following the treatment . Adverse effects and mortality were not observed during or after the therapy . CONCLUSION Pentaglobin treatment of nosocomial sepsis could be used as an adjunct therapy without any adverse short-term reactions , even in very low birthweight pre-term infants Thirty-seven neonates with confirmed septicemia through hemoculture were studied . Of them , 18 were treated with antibiotic and the other 19 were given 500 mg/kg of intravenous immunoglobin with a pH of 4.25 ( IGIV ) . The greater part of the neonates in this study were full-term or near full-term . There were no differences in age , gestational age and weight , nor in mortality , the bacterias found and the clinical manifestations which were seen in both groups . Yet , the hospitalary stay was shorter for those in the group treated with IGIV ( 13.9 + /- 5.7 days ) than in the trial group ( 24.4 + /- 10.3 days ) ; as well as some clinical manifestations like diarrhea and splenomegalia ( P < 0.05 ) . The serum of the neonates from the IGIV group showed a greater capacity of opsonization and inhibition of bacterial growth than those in the trial group ( P < 0.001 ) , coinciding with an increase of 300 mg/dL in the serum levels of IgG of the group treated with IGIV from the 3rd day of the study and the C4 and B-Properdine factor serum levels from the 7th day of the study , while in the trial group , there were no changes in these factors ( P < 0.001 ) . Even though no differences were seen in the mortality rate due to septicemia , the results suggest a much shorter evolution of the illness in patients treated with IGIV  . In addition , the serum of those patients treated with IGIV showed in in vitro studies , a better bacteriostatic activity and a better capacity to opsonize the bacterias isolated in the hemocultures . ( ABSTRACT TRUNCATED AT 250 WORDS Despite the development of newer generation of antibiotics , mortality from neonatal sepsis  remains high . In a prospect i ve , r and omized study , we investigated the use of IgM-enriched immunoglobulin therapy in  neonatal sepsis . Two groups of 30 infants each ( matched for gestational age , sex , weight , and other variables ) were r and omly allocated to receive either antibiotics alone ( control group ) or antibiotics plus 5 mL/kg/d for four days of IgM-enriched immunoglobulin intravenously ( immunotherapy group ) .  Mortality from sepsis in the control group was 20 % ( 6/30 ) , while in the immunotherapy group it was 3.3 % ( 1/30 ) . We conclude that IgM-enriched immunoglobulin therapy in conjunction with antibiotic therapy significantly reduces mortality from neonatal sepsis OBJECTIVE Early-onset sepsis ( occurring within 72 hours of birth ) is included in the differential diagnosis of most very low birth weight ( VLBW ) neonates . To determine the current incidence of early-onset sepsis , risk factors for disease , and the impact of early-onset sepsis on subsequent hospital course , we studied a cohort of 7861 VLBW neonates ( 401 to 1500 gm ) admitted to the 12 National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network centers during a 32-month period ( 1991 - 1993 ) . METHODS The NICHD Neonatal Research Network maintains a prospect ively collected registry on all VLBW neonates born or cared for at participating centers . Data from this registry were analyzed retrospectively . RESULTS Blood culture-proven early-onset sepsis was uncommon , occurring in only 1.9 % of VLBW neonates . Group B streptococcus was the most frequent pathogen associated with early-onset sepsis ( 31 % ) , followed by Escherichia coli ( 16 % ) and Haemophilus influenzae ( 12 % ) . Decreasing gestational age was associated with increased rates of infection . Antibiotic therapy for suspected sepsis is frequently initiated at birth in VLBW neonates . Almost half of the infants in this cohort were considered to have clinical sepsis and continued to receive antibiotics for 5 or more days , despite a negative blood culture result in 98 % of cases . These findings underscore the difficulty of ruling out sepsis in the symptomatic immature neonate and the special concern for culture-negative clinical sepsis in the face of maternal antibiotic use . Neonates with early-onset sepsis were significantly more likely to have subsequent comorbidities , including severe intraventricular hemorrhage , patent ductus arteriosus , and prolonged assisted ventilation . Although 26 % of VLBW neonates with early-onset sepsis died , only 4 % of the 950 deaths that occurred in the first 72 hours of life were attributed to infection . For those infants discharged alive , early-onset sepsis was associated with a significantly prolonged hospital stay ( 86 vs 69 days ; p < 0.02 ) . CONCLUSIONS Early-onset sepsis remains an important but uncommon problem among VLBW preterm infants . Improved diagnostic strategies are needed to enable the clinician to distinguish between the infected and the uninfected VLBW neonate with symptoms and to target continued antibiotic therapy to those who are truly infected Newborn infants may have IgG deficiencies that increase their susceptibility to bacterial infection . To determine whether intravenous immune globulin ( IVIG ) therapy improves survival rates in early-onset sepsis , we prospect ively entered 753 neonates ( birth weight 500 to 2000 gm , gestation less than or equal to 34 weeks , age less than or equal to 12 hours ) into a multicenter , double-blind , controlled trial . Blood culture specimens were obtained and infants r and omly assigned to receive 10 ml ( per kilogram ) intravenously of a selected IVIG ( 500 mg/kg ) or albumin ( 5 mg/kg ) preparation . Maternal and neonatal risk factors were not different between groups . Thirty-one babies ( 4.2 % ) had early-onset sepsis ; the causative organisms were group B streptococcus ( 12 babies ) , Escherichia coli ( 6 ) , and others ( 13 ) . Of these 31 neonates , 7 ( 23 % ) died . Total serum IgG was higher for 7 days after IVIG therapy than after albumin treatment ( p less than 0.05 ) . During these 7 days , 5 ( 30 % ) of 17 albumin-treated and none of 14 IVIG-treated patients died ( p less than 0.05 ) . The survival rate at 56 days of age , however , was not significantly improved . Group B streptococcus type-specific IgG antibody was significantly increased after IVIG treatment and appeared to be related to the amount of IVIG specific antibody . Infusion-related adverse reactions were less frequent in patients receiving IVIG therapy ( 0.5 % ) than in those receiving albumin . The IVIG therapy in neonates with early-onset sepsis , while reducing the early mortality rate , did not significantly affect the overall survival rate . Further studies are necessary to confirm these findings and to determine more effective therapeutic regimens The therapeutic effect of a polyvalent immunoglobulin preparation for intravenous use was tested in 82 newborns with bacterial infections . 35 of the children had neonatal sepsis , whereas in the other 47 bacteremia was not detectable . Treatment consisted either of antibiotics only or of antibiotics combined w 
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The undisputable results of the INIS trial , which enrolled 3493 infants , and our meta-analyses ( n = 3973 ) showed no reduction in mortality during hospital stay , or death or major disability at two years of age in infants with suspected or proven infection .
Although based on a small sample size ( n = 266 ) , this up date provides additional evidence that IgM-enriched IVIG does not significantly reduce mortality during hospital stay in infants with suspected infection .