Intravenous immunoglobulin therapy for prevention of infection in high-risk premature infants: report of a multicenter, double-blind study. Intravenous gammaglobulin therapy for prophylaxis of infection in high-risk neonates. Multicentre trial of antepartum low-dose anti-D immunoglobulin. The use of intravenously administered immunoglobulins in the prevention of severe infection in very low birth weight neonates. Multicenter randomized placebo controlled trial of therapy with intravenous immunoglobulin in decreasing mortality due to neonatal sepsis. Effectiveness of antibiotic prophylaxis in preventing bacteriuria after multichannel urodynamic investigations: a blind, randomized study in 124 female patients. A multimodal approach to central venous catheter hub care can decrease catheter-related bloodstream infection. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A behavioral intervention to improve obstetrical care.
The effectiveness of intravenously administered immunoglobulin (Ig) therapy for prophylaxis of infection was evaluated in high-risk preterm infants. Two hundred thirty-five premature newborns were randomly assigned, in a double-blind controlled trial, to treatment and placebo groups. Thirty-five infants (29%) of the Ig group and 29 (25%) of the placebo group had one or more episodes of certain infection. Thirty infants (25%) of the Ig group and 18 (16%) of the placebo group had one or more episodes of probable infection. No significant differences were observed in the incidence of certain or probable infection in treated and control infants. Nevertheless, among the infants who had one or more certain or probable episodes of infection, more of them belonged to the Ig group than to the placebo group. The possible deleterious effect of the administration of large amounts of polyspecific Ig is discussed. The safety and effectiveness of intravenously administered gammaglobulin therapy for prophylaxis of infection was evaluated in 133 high-risk neonates. The infants were stratified into two groups: infants with birth weight less than or equal to 1500 g and gestational age less than or equal to 34 weeks, and infants with birth weight greater than 1500 g and receiving intensive care and assisted ventilation. Forty-three infants in group 1 and 25 in group 2 were given gammaglobulin at a dose of 0.5 g/kg/wk, for 1 month in group 1 and during intensive care in group 2. Forty infants in group 1 and 25 in group 2 served as controls. Serum total IgG and group B streptococcus-, Escherichia coli-, and CMV-specific IgG levels similar to those in adult controls were observed in the treated infants 2 hours after gammaglobulin administration. In the treated infants in group 1, the incidence of infection was 51%, and of septicemia 5%; in the controls the incidence of infection was 77% (P less than 0.02), and of septicemia 20% (P less than 0.05). Infection was the main cause of death in one treated and six control infants in group 1 (P less than 0.04). In the infants with birth weight greater than 1500 g receiving intensive care and assisted ventilation, no significant differences were observed in the incidence of infection or septicemia in treated and control infants. No side effects were observed after intravenous gammaglobulin administration. These data show that intravenously administered gammaglobulin is both safe and effective for prophylaxis of infection in preterm very low birth weight infants. Routine antenatal Rh immunoprophylaxis would substantially increase the use of anti-D Ig in the U.K. As availability of anti-D Ig is one factor influencing a decision to introduce routine antenatal prophylaxis, a trial was undertaken to test the efficacy of a lower dose of anti-D Ig than that used in earlier studies. RhD-negative primigravidae were randomized as controls or recipients of two doses of 250iu of anti-D Ig given at 28 and 34 weeks gestation. Blood samples were tested at delivery and at 6 months postpartum for the presence of immune anti-D, and again later if results were equivocal. Nine (1.5%) out of 595 control patients had immune anti-D at follow-up at 6 months and later; 4 (0.78%) of 513 treated women were immunized. It was concluded that, while two doses of 250iu of anti-D Ig may reduce alloimmunization, they are not as effective as two doses of 500iu in a previous trial. In a randomized prospective study in 116 selected neonates with very low birth weight, the effect of standard doses of intravenously administered immunoglobulins (IVIG) on the occurrence of severe infections was studied. No difference in infection rate or severity of infection could be observed between the treated neonates and the control group. The lack of effect could not be explained by an insufficient increase in the IgG serum levels, or inversely, by high immunosuppressive IgG levels. It is concluded that in very low birth weight neonates the administration of IVIG, under the conditions used in this investigation, does not protect against severe infection. To determine whether therapy with intravenous immunoglobulin G (IVIG) would decrease mortality in neonatal sepsis.
                Three tertiary care neonatal intensive care units in the city of Bangalore.
                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 randomized 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.
                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 weight (2144+/-675 g vs. 2072+/-682 g), gestation (37.0+/-3.56 vs. 35.8+/-3.52 weeks), sex distribution, duration of stay, and number requiring ventilation. The placebo group had a significantly higher number of babies with positive blood culture. Seven babies in each group died (p>0.05). There was no significant benefit in using IVIG (OR 1.0; 95% CI 0.25-4.07) (p = 0.74).
                In the sample studied therapy with IVIG did not reduce mortality in neonatal sepsis One hundred twenty-four women with chronic, persistent lower urinary tract symptoms who had been scheduled for elective urodynamic investigations at Mount Sinai's Urodynamic Investigative Unit were divided into two blind, randomized groups, receiving either a placebo or prophylactic antibiotic. At the time of urodynamic testing, the rate of unsuspected urinary tract infection was 8.1%. There was no statistically significant decrease in postinstrumentation infection rate in the group who received prophylactic antibiotics. We conclude that, given in the fashion described in the study, prophylactic antibiotics are not effective in preventing urinary tract infections caused by urodynamic testing. This study was conducted to investigate decreases in catheter-related bloodstream infections (CRBSIs) through an evidence-based multimodal intervention.
                This was a prospective interventional study of neonates with a central venous catheter (CVC) from a neonatal intensive care unit database, involving implementation of a multimodal approach to central venous catheter hub care using 2% chlorhexidine in 70% isopropyl alcohol and education of medical staff by audiovisual presentations. CRBSI rates in the pre-intervention period and postintervention period were compared.
                A total of 373 patients with a CVC (163 in the preintervention period and 210 in the postintervention period) were studied. Patient demographic and clinical characteristics were similar in the 2 periods. Extremely low birth weight infants constituted 40% of the cohort in the preintervention period and 38% of the cohort in the postintervention period. The CRBSI rate in patients with a umbilical artery catheter and an umbilical vein catheter decreased from 15/1000 catheter-days to 10/1000 catheter-days (odds ratio [OR], 0.47; 95% confidence interval [CI], 0.17-0.91). The CRBSI rate in patients with a peripherally inserted central catheter decreased from 23/1000 catheter-days to 10/1000 catheter-days (OR, 0.33; 95% CI, 0.12-0.91). These decreased CRBSI rates were sustained despite high device utilization. The incidence of gram-negative septicemia also decreased. Ten CRBSIs were prevented by this multimodal approach, representing significant health care cost savings.
                This study demonstrates significant decreases in CRBSI rate for all catheter types and birth weight categories associated with the multimodal intervention. Audiovisual education is an effective tool for practice change. Reeducation and compliance monitoring should be part of all nosocomial infection prevention strategies, resulting in significant savings in health care costs.
                Copyright 2010 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved. Intrauterine infection is thought to be one cause of preterm premature rupture of the membranes (PPROM). Antibiotic therapy has been shown to prolong pregnancy, but the effect on infant morbidity has been inconsistent.
                To determine if antibiotic treatment during expectant management of PPROM will reduce infant morbidity.
                Randomized, double-blind, placebo-controlled trial.
                University hospitals of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.
                A total of 614 of 804 eligible gravidas with PPROM between 24 weeks' and 0 days' and 32 weeks' and 0 days' gestation who were considered candidates for pregnancy prolongation and had not received corticosteroids for fetal maturation or antibiotic treatment within 1 week of randomization.
                Intravenous ampicillin (2-g dose every 6 hours) and erythromycin (250-mg dose every 6 hours) for 48 hours followed by oral amoxicillin (250-mg dose every 8 hours) and erythromycin base (333-mg dose every 8 hours) for 5 days vs a matching placebo regimen. Group B streptococcus (GBS) carriers were identified and treated. Tocolysis and corticosteroids were prohibited after randomization.
                The composite primary outcome included pregnancies complicated by at least one of the following: fetal or infant death, respiratory distress, severe intraventricular hemorrhage, stage 2 or 3 necrotizing enterocolitis, or sepsis within 72 hours of birth. These perinatal morbidities were also evaluated individually and pregnancy prolongation was assessed.
                In the total study population, the primary outcome (44.1 % vs 52.9%; P=.04), respiratory distress (40.5% vs 48.7%; P=.04), and necrotizing enterocolitis (2.3% vs 5.8%; P=.03) were less frequent with antibiotics. In the GBS-negative cohort, the antibiotic group had less frequent primary outcome (44.5% vs 54.5%; P=.03), respiratory distress (40.8% vs 50.6%; P=.03), overall sepsis (8.4% vs 15.6%; P=.01), pneumonia (2.9% vs 7.0%; P=.04), and other morbidities. Among GBS-negative women, significant pregnancy prolongation was seen with antibiotics (P<.001).
                We recommend that women with expectantly managed PPROM remote from term receive antibiotics to reduce infant morbidity. Implementation of evidence-based obstetrical practices remains a significant challenge. Effective strategies to disseminate and implement such practices are needed.
                We randomly assigned 19 hospitals in Argentina and Uruguay to receive a multifaceted behavioral intervention (including selection of opinion leaders, interactive workshops, training of manual skills, one-on-one academic detailing visits with hospital birth attendants, reminders, and feedback) to develop and implement guidelines for the use of episiotomy and management of the third stage of labor or to receive no intervention. The primary outcomes were the rates of prophylactic use of oxytocin during the third stage of labor and of episiotomy. The main secondary outcomes were postpartum hemorrhage and birth attendants' readiness to change their behavior with regard to episiotomies and management of the third stage of labor. The outcomes were measured at baseline, at the end of the 18-month intervention, and 12 months after the end of the intervention.
                The rate of use of prophylactic oxytocin increased from 2.1% at baseline to 83.6% after the end of the intervention at hospitals that received the intervention and from 2.6% to 12.3% at control hospitals (P=0.01 for the difference in changes). The rate of use of episiotomy decreased from 41.1% to 29.9% at hospitals receiving the intervention but remained stable at control hospitals, with preintervention and postintervention values of 43.5% and 44.5%, respectively (P<0.001 for the difference in changes). The intervention was also associated with reductions in the rate of postpartum hemorrhage of 500 ml or more (relative rate reduction, 45%; 95% confidence interval [CI], 9 to 71) and of 1000 ml or more (relative rate reduction, 70%; 95% CI, 16 to 78). Birth attendants' readiness to change also increased in the hospitals receiving the intervention. The effects on the use of episiotomy and prophylactic oxytocin were sustained 12 months after the end of the intervention.
                A multifaceted behavioral intervention increased the prophylactic use of oxytocin during the third stage of labor and reduced the use of episiotomy. (ClinicalTrials.gov number, NCT00070720 [ClinicalTrials.gov]; Current Controlled Trials number, ISRCTN82417627 [controlled-trials.com].).
                Copyright 2008 Massachusetts Medical Society.
Intrapartum antibiotic prophylaxis appeared to reduce EOGBSD, but this result may well be a result of bias as we found a high risk of bias for one or more key domains in the study methodology and execution. There is lack of evidence from well designed and conducted trials to recommend IAP to reduce neonatal EOGBSD.
Ideally the effectiveness of IAP to reduce neonatal GBS infections should be studied in adequately sized double-blind controlled trials. The opportunity to conduct such trials has likely been lost, as practice guidelines (albeit without good evidence) have been introduced in many jurisdictions.