***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 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: In a multicenter , r and omized , placebo-controlled clinical trial of pertussis immune globulin , intravenous ( P-IGIV ) , 25 infants hospitalized with pertussis were enrolled in 24 months ( 15 % of the target sample size ) before the study was prematurely terminated because of expiration of the P-IGIV lots and unavailability of additional study product . Although well tolerated , there was no difference in the number or rate of improvement of symptoms ( paroxysmal cough , whoop , apnea , bradycardia , oxygen desaturations ) in P-IGIV recipients compared with placebo OBJECTIVE Late-onset sepsis ( occurring after 3 days of age ) is an important problem in very low birth weight ( VLBW ) infants . To determine the current incidence of late-onset sepsis , risk factors for disease , and the impact of late-onset sepsis on subsequent hospital course , we evaluated a cohort of 6956 VLBW ( 401 - 1500 g ) neonates admitted to the clinical centers of the National Institute of Child Health and Human Development Neonatal Research Network over a 2-year period ( 1998 - 2000 ) . METHODS The National Institute of Child Health and Human Development Neonatal Research Network maintains a prospect i ve registry of all VLBW neonates admitted to participating centers within 14 days of birth . Exp and ed infection surveillance was added in 1998 . RESULTS Of 6215 infants who survived beyond 3 days , 1313 ( 21 % ) had 1 or more episodes of blood culture-proven late-onset sepsis . The vast majority of infections ( 70 % ) were caused by Gram-positive organisms , with coagulase-negative staphylococci accounting for 48 % of infections . Rate of infection was inversely related to birth weight and gestational age . Complications of prematurity associated with an increased rate of late-onset sepsis included patent ductus arteriosus , prolonged ventilation , prolonged intravascular access , bronchopulmonary dysplasia , and necrotizing enterocolitis . Infants who developed late-onset sepsis had a significantly prolonged hospital stay ( mean length of stay : 79 vs 60 days ) . They were significantly more likely to die than those who were uninfected ( 18 % vs 7 % ) , especially if they were infected with Gram-negative organisms ( 36 % ) or fungi ( 32 % ) . CONCLUSIONS Late-onset sepsis remains an important risk factor for death among VLBW preterm infants and for prolonged hospital stay among VLBW survivors . Strategies to reduce late-onset sepsis and its medical , social , and economic toll need to be addressed urgently 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 BACKGROUND Nosocomial infection is a major risk for premature infants with very low birth weights . One reason for their susceptibility to infection may be antibody deficiency , since there is little transfer of maternal IgG to the fetus before 32 weeks ' gestation . METHODS We conducted a multicenter , double-blind study of neonates weighing 500 to 1750 g at birth . A total of 588 neonates were r and omly assigned , with stratification for birth weight , to receive periodic intravenous infusions of either immune globulin ( 500 mg per kilogram of body weight per day ) or a placebo .  Mortality , morbidity , and nosocomial infection during the next 56 days were assessed . RESULTS The infusions were well tolerated ; mild , reversible adverse reactions occurred in five infants in each group . There was a significant reduction in the risk of a first nosocomial infection in the recipients of immune globulin as compared with the placebo recipients ( relative risk , 0.7 ; 95 percent confidence interval , 0.5 to 0.9 ) . About 85 percent of the nosocomial infections were bacterial ; the majority of these were caused by coagulase-negative staphylococci or Staphylococcus aureus . The neonates who received immune globulin had fewer mean days of hospitalization than the controls ( 62 vs. 68 , P = 0.15 ) ; among the infants with infections , the difference in the mean length of the hospital stay was even greater ( 80 days vs. 101 days , P = 0.02 ) . CONCLUSIONS For premature infants weighing between 500 and 1750 g at birth , treatment with intravenous infusions of immune globulin is safe and reduces the risk of nosocomial infection 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 Blood cultures were performed on 141 newborn infants who had clinical features or laboratory data indicative of sepsis between January 1993 and April 1995 . Clinical features included respiratory deterioration , poor activity , abdominal distension and apnea . Abnormal laboratory data included leukocytosis , leukopenia , elevated C-reactive protein values or increased immature neutrophil counts . The 141 neonates with suspected bacterial infections received antibiotic therapy and were r and omly divided into two groups . One group received a single dose of 500 mg/kg of intravenous immunoglobulin ( IVIG ) , while the other group received placebo ( 0.9 % sodium chloride ) .  Patients with negative blood cultures were excluded from this study . A total of 56 neonates with positive blood cultures were enrolled in this study . The IVIG-treated group and placebo-treated group consisted of 10 premature and 18 term neonates , respectively . Another 10 healthy premature and healthy 18 term neonates were selected as the control group . Serum IgG values increased significantly 1 and 2 weeks after administration of IVIG in the IVIG-treated group . However , there was no significant difference in the duration of treatment and mortality between the IVIG-treated and placebo-treated groups . Our preliminary observations suggest that administration of 500 mg/kg IVIG to neonates with sepsis had no effect on reducing mortality . In addition , it shortened neither the duration of antibiotic therapy nor hospitalization . No adverse reactions to the IVIG infusions were noted during the study 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 wih immunoglobulin SRK on an alternating basis for the first six days . Immunoglobulin substitution was tolerated without complications . In the group of infants with neonatal sepsis , two of 20 ( 10 % ) who were substituted with immunoglobulin and four of 15 ( 26 % ) who received no immunoglobulin  died . Likewise , in the group of patients without detectable bacteremia , two of 21 on immunoglobulin substitution ( 10 % ) and four of the 26 who were not substituted ( 15 % ) died . The low mortality observed in the present study was attributed to efforts at early diagnosis and conventional early treatment on the one h and , and to immunoglobulin substitution on the other . To detect possible late sequelae of immunoglobulin therapy , particularly in hypogammaglobulinemic premature newborns , clinical and immunological investigations were performed in the septic patient group at the age of one to four years . There were no indications that administration of immunoglobulins during the neonatal period might have had an adverse effect on psychomotor and somatic development or on the immunological maturation of the infants OBJECTIVE To determine whether therapy with intravenous immunoglobulin G ( IVIG ) would decrease mortality in neonatal sepsis . SETTING Three tertiary care neonatal intensive care units in the city of Bangalore . METHODS All neonates admitted to the Neonatal Intensive Care Units with the clinical diagnosis of sepsis and having at least C-reactive protein and one other rapid diagnostic criteria positive were enrolled . Neonates with a birth weight of less than 1000 g and those with any major congenital malformation were excluded . The neonates were r and omized to receive 1 g/kg of IVIG on three consecutive days or an equivalent amount of placebo . The rest of the treatment including antibiotics and supportive care was as per the treating physician 's decision . The main outcome variable was survival . RESULTS The trial was carried out over a period of 8 months and recruited 58 neonates . Seven neonates who qualified but did not receive either IVIG or placebo were taken into a separate control group , and one baby who received only one dose of IVIG was excluded from the analysis . Twenty-five neonates were enrolled into the IVIG arm and 25 in the placebo arm . The neonates in the therapy and placebo groups were comparable in terms of birth 
    Output:
    
The global effect of this outcome showed no statistically significant difference between the groups .
Although there is a statistically significant reduction of 1.24 days in the length of hospital stay with the use of intravenous immunoglobulin , such difference is clinical ly irrelevant and its high cost does not warrant its routine use in medical practice .
We concluded that the use of adjuvant intravenous immunoglobulin shows no benefit regarding mortality , whereas the reduction in the length of hospital stay is irrelevant