Vaginal chlorhexidine during labour to prevent early-onset neonatal group B streptococcal infection.

BACKGROUND: Although early-onset group B ß-hemolytic streptococcus (GBS) infection is rare, it accounts for approximately 30% of neonatal infections, has a high mortality rate, and is acquired through vertical transmission from colonized mothers. Several trials have demonstrated the efficacy of intrapartum antibiotic prophylaxis (IAP) for preventing early-onset disease (EOD). Vaginal disinfection with chlorhexidine during labour has been proposed as another strategy for preventing GBS EOD in the preterm and term neonate. Chlorhexidine has been found to have no impact on antibiotic resistance, is inexpensive, and applicable to poorly equipped delivery sites. OBJECTIVES: To determine the effectiveness of vaginal disinfection with chlorhexidine during labour in women who are colonized with GBS for preventing early-onset GBS infection in preterm and term neonates. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014) and reference lists of retrieved studies. SELECTION CRITERIA: Randomized and quasi-randomized trials comparing vaginal disinfection with chlorhexidine (vaginal wash or gel/cream) versus placebo, or no treatment. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed the trials for inclusion and risk of bias, extracted the data and checked them for accuracy. MAIN RESULTS: We identified no new trials eligible for inclusion in this update. One study was moved from included to excluded studies from the previous version of the review. Four studies, including 1125 preterm and term infants, met the inclusion criteria and reported on at least one of the outcomes of interest. For the comparison chlorhexidine (vaginal wash or gel) versus placebo or no treatment, two studies (n = 987) were pooled. There was no statistically significant difference in early-onset GBS disease (sepsis and/or meningitis) comparing chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment; risk ratio (RR), 2.32 (95% confidence interval (CI) 0.34 to 15.63); I-squared (I²) = 0% or in GBS pneumonia; RR 0.35 (95% CI 0.01 to 8.6); test for heterogeneity not applicable. The outcome of colonization of the neonate with GBS was reported in three studies (n = 328); RR 0.64 (95% CI 0.40 to 1.01; there was substantial between-study heterogeneity (Chi² = 3.19; P = 0.20; I² = 37%). Maternal mild side effects (stinging or local irritation) (three trials, 1066 women) were more commonly seen in women treated with chlorhexidine (RR 8.50 (95% CI 1.60 to 45.28); there was no heterogeneity (Chi² = 0.01, df = 1 (P = 0.91); I² = 0%). No side effects were reported among the neonates.For the comparison chlorhexidine vaginal wash verus mechanical washing with placebo or no treatment (one study, n = 79), there was a significant reduction in neonatal colonization with GBS; RR 0.32 (95% CI 0.12 to 0.90). Tests for heterogeneity not applicable. There were no other significant results for this comparison.For the comparison chlorhexidine gel or cream versus placebo or no treatment, there were no statistically significant results for the outcomes reported on.The quality of the trials varied and the overall risk of bias was rated as unclear or high. The quality of the evidence using GRADE was very low for the outcomes of the comparison chlorhexidine (vaginal wash or gel/cream) versus placebo or no treatment. These outcomes included: early-onset GBS disease (sepsis and/or meningitis), GBS pneumonia, neonatal colonization with GBS, neonatal mortality due to early-onset GBS infection and adverse (mild) effects in the mother and the neonate. AUTHORS' CONCLUSIONS: The quality of the four included trials varied as did the risk of bias and the quality of the evidence using GRADE was very low. Vaginal chlorhexidine was not associated with reductions in any of the primary outcomes of early-onset GBS disease (sepsis and/or meningitis) or GBS pneumonia. Vaginal chlorhexidine may reduce GBS colonization of neonates. The intervention was associated with an increased risk of maternal mild adverse effects. The review currently does not support the use of vaginal disinfection with chlorhexidine in labour for preventing early-onset disease. Results should be interpreted with caution as the methodological quality of the studies was poor. As early-onset GBS disease is a rare condition trials with very large sample sizes are needed to assess the effectiveness of vaginal chlorhexidine to reduce its occurrence. In the era of intrapartum antibiotic prophylaxis, such trials may be difficult to justify especially in developed countries.

What do we know about the economic impact of fetal alcohol spectrum disorder? A systematic literature review.

AIMS: The objective of this study was to conduct a systematic review of the literature related to the measurement of the economic impact of Fetal Alcohol Spectrum Disorder (FASD) in different countries and to categorize the available literature. METHODS: A systematic literature search of the studies concerning the economic impact of FASD was conducted using multiple electronic bibliographic databases. RESULTS: The literature on the economic burden of FASD is scarce. There are a limited number of studies found in Canada and the USA, and data from the rest of the world are absent. Existing estimates of the economic impact of FASD demonstrate significant cost implications on the individual, the family and society. However, these estimates vary considerably due to the different methodologies used by different studies. CONCLUSION: Limitations and gaps in the existing methodologies of calculating the economic costs of FASD are discussed. It is evident that there is an urgent need to develop a comprehensive and sound methodology for calculating the economic impact of FASD to the society.

The remarkably high prevalence of epilepsy and seizure history in fetal alcohol spectrum disorders.

BACKGROUND: Fetal alcohol spectrum disorder (FASD) is the umbrella term that describes the range of adverse developmental outcomes that may occur in the offspring of mothers who drink alcohol during pregnancy. FASD is associated with several comorbidities including epilepsy. The objective of the study was to evaluate the prevalence of epilepsy or a history of seizures in subjects with FASD and the contribution of relevant risk factors. METHODS: A retrospective chart review was conducted on all active charts (N = 1063) at two FASD clinics. After exclusion of subjects without a confirmed diagnosis, a total of 425 subjects between the ages of 2-49 were included in the analysis. The relationships between FASD diagnosis and other risk factors for co-occurrence of epilepsy or a seizure disorder (e.g., extent of exposure to alcohol and other drugs, type of birth, and trauma) were examined using chi-square and multivariate multinomial logistic regression. RESULTS: Twenty-five (5.9%) individuals in the study population had a confirmed diagnosis of epilepsy, and 50 (11.8%) had at least one documented seizure episode, yielding an overall prevalence of 17.7% in this population. Importantly, a history of epilepsy or seizures was not different across the three diagnostic subgroups. In those subjects with available maternal drinking histories, first trimester exposure or drinking throughout all three trimesters were the predominant forms of fetal exposure. None of the other risk factors were associated with a greater prevalence of epilepsy or seizures. CONCLUSIONS: There is a remarkably high prevalence of epilepsy/seizures in the FASD population.

Psychological and/or educational interventions for reducing alcohol consumption in pregnant women and women planning pregnancy.

BACKGROUND: It is estimated that more than 20% of pregnant women worldwide consume alcohol. Current research suggests that alcohol intake of seven or more standard drinks (one standard drink = 13.6 grams of absolute alcohol) per week during pregnancy places the baby at risk of serious, lifelong developmental and cognitive disabilities. Psychological and educational interventions may help women to reduce their alcohol intake during pregnancy. OBJECTIVES: To determine the effectiveness of psychological and educational interventions to reduce alcohol consumption during pregnancy in pregnant women or women planning pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (August 2008), CENTRAL (The Cochrane Library 2007, Issue 4), MEDLINE (1966 to November 2007), EMBASE (1980 to November 2007), CINAHL (1982 to November 2007), Counsel.Lit (1980 to November 2007), PsycLIT (1974 to November 2007) and PsycINFO (1967 to November 2007) and checked cited references from retrieved articles. SELECTION CRITERIA: Randomized controlled trials examining the effectiveness of psychological and educational interventions for reducing consumption of alcohol among pregnant women, or women planning for pregnancy. DATA COLLECTION AND ANALYSIS: At least two review authors independently extracted information from the results sections of the included studies. MAIN RESULTS: Four studies met the inclusion criteria (715 pregnant women), and reported on at least one of the outcomes of interest. We performed no meta-analyses as the interventions and outcomes measured in the studies were not sufficiently similar. For most outcomes there were no significant differences between groups; and results relating to abstaining or reducing alcohol consumption were mixed. Results from individual studies suggest that interventions may encourage women to abstain from alcohol in pregnancy. There was very little information provided on the effects of interventions on the health of mothers and babies. AUTHORS' CONCLUSIONS: The evidence from the limited number of studies suggests that psychological and educational interventions may result in increased abstinence from alcohol, and a reduction in alcohol consumption among pregnant women. However, results were not consistent, and the paucity of studies, the number of total participants, the high risk of bias of some of the studies, and the complexity of interventions limits our ability to determine the type of intervention which would be most effective in increasing abstinence from, or reducing the consumption of, alcohol among pregnant women.

Cost of fetal alcohol spectrum disorder in Canada.

QUESTION: I have heard that thousands of Canadian kids are affected by fetal alcohol spectrum disorders. Has there been any attempt to estimate what it costs our society? ANSWER: In a recent Canadian study, the lifetime cost of fetal alcohol spectrum disorders was estimated at $1 million per case. With an estimated 4000 new cases yearly, this translates to $4 billion annually.

Health-related quality of life of Canadian children and youth prenatally exposed to alcohol.

BACKGROUND: In Canada, the incidence of Fetal Alcohol Spectrum Disorder (FASD) has been estimated to be 1 in 100 live births. Caused by prenatal exposure to alcohol, FASD is the leading cause of neuro-developmental disabilities among Canadian children, and youth. OBJECTIVE: To measure the health-related quality of life (HRQL) of Canadian children and youth diagnosed with FASD. METHODS: A prospective cross-sectional study design was used. One-hundred and twenty-six (126) children and youth diagnosed with FASD, aged 8 to 21 years, living in urban and rural communities throughout Canada participated in the study. Participants completed the Health Utilities Index Mark 3 (HUI3). HUI3 measures eight health attributes: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Utilities were used to measure a single cardinal value between 0 and 1.0 (0 = all-worst health state; 1 = perfect health) to reflect the global HRQL for that child. Mean HRQL scores and range of scores of children and youth with FASD were calculated. A one-sample t-test was used to compare mean HRQL scores of children and youth with FASD to those from the Canadian population. RESULTS: Mean HRQL score of children and youth with FASD was 0.47 (95% CI: 0.42 to 0.52) as compared to a mean score of 0.93 (95% CI: 0.92 to 0.94) in those from the general Canadian population (p < 0.001). Children demonstrated moderate to severe dysfunction on the single-attributes of cognition and emotion. CONCLUSION: Children and youth with FASD have significantly lower HRQL than children and youth from the general Canadian population. This finding has significant implications for practice, policy development, and research.

Folic acid transport to the human fetus is decreased in pregnancies with chronic alcohol exposure.

BACKGROUND: During pregnancy, the demand for folic acid increases since the fetus requires this nutrient for its rapid growth and cell proliferation. The placenta concentrates folic acid into the fetal circulation; as a result the fetal levels are 2 to 4 times higher than the maternal level. Animal and in vitro studies have suggested that alcohol may impair transport of folic acid across the placenta by decreasing expression of transport proteins. We aim to determine if folate transfer to the fetus is altered in human pregnancies with chronic alcohol consumption. METHODOLOGY/PRINCIPAL FINDINGS: Serum folate was measured in maternal blood and umbilical cord blood at the time of delivery in pregnancies with chronic and heavy alcohol exposure (n = 23) and in non-drinking controls (n = 24). In the alcohol-exposed pairs, the fetal:maternal serum folate ratio was ≤ 1.0 in over half (n = 14), whereas all but one of the controls were >1.0. Mean folate in cord samples was lower in the alcohol-exposed group than in the controls (33.15 ± 19.89 vs 45.91 ± 20.73, p = 0.04). CONCLUSIONS/SIGNIFICANCE: Our results demonstrate that chronic and heavy alcohol use in pregnancy impairs folate transport to the fetus. Altered folate concentrations within the placenta and in the fetus may in part contribute to the deficits observed in the fetal alcohol spectrum disorders.

Feeling different: the experience of living with fetal alcohol spectrum disorder.

BACKGROUND: In Canada the incidences of Fetal Alcohol Spectrum Disorder (FASD) is estimated to be in 1 in 100 live births caused by prenatal exposure to alcohol, the disorder is the leading cause of developmental and cognitive disabilities among Canadian children and its effects are life lasting. No research has attempted to describe the experience of living with FASD from the perspective of Canadian children. PURPOSE: The main purpose of this study was to describe the children's experience of living with FASD. METHODS: A qualitative method was used to examine the children's experiences. Twenty-two (22) children, aged 6 to 18 years, living in urban and rural communities across Canada participated in an unstructured in-depth interview. Data was analysed using Colaizzi's qualitative method. RESULTS: For all children in this study, living day-to-day with FASD meant feeling different. Within this construct knowing the disability; feeling alone-feeling supported, and overcoming the disability were dominant themes which emerged. CONCLUSION: Implications for practice and research have been described. KEYWORDS: Fetal Alcohol Spectrum Disorder, children's experience, qualitative research.

Transcutaneous bilirubin measurement at the time of hospital discharge in a multiethnic newborn population.

BACKGROUND: Severe neonatal hyperbilirubinemia continues to occur in healthy newborns. Recent guidelines have supported using transcutaneous devices in estimating bilirubin levels. Previous studies using these devices are limited. METHODS: Newborns requiring serum bilirubin level measurements before hospital discharge were recruited prospectively. The agreement between a transcutaneous bilirubin (TCB) and total serum bilirubin (TSB) level was assessed. Sensitivity analysis was conducted. RESULTS: A total of 430 infants were enrolled. Correlation between the values was high (Pearson's correlation coefficient 0.83; Lin's concordance coefficient 0.81 [95% CI 0.77 to 0.84]; P<0.001). The mean (± SD) TSB level was 194±60 µmol/L. The TCB measurement tended to overestimate the value (mean difference 12.7), with wide 95% limits of agreement (-52 µmol/L to 77 µmol/L). Sensitivity and specificity analysis of TCB values allowed estimation of clinically important TSB levels. CONCLUSIONS: The TCB correlated, but was imprecise in predicting TSB. TCB values can be used at the time of discharge to safely plan care for jaundiced infants if the limits of agreement are considered and clinical judgment is maintained.

The burden of prenatal exposure to alcohol: revised measurement of cost.

BACKGROUND: In Canada the incidence of Fetal Alcohol Spectrum Disorder (FASD) is estimated to be 1 in 100 live births. FASD is the leading cause of developmental and cognitive disabilities in Canada. Only one study has examined the cost of FASD in Canada. In that study we did not include prospective data for infants under the age of one year, costs for adults beyond 21 years or costs for individuals living in institutions. OBJECTIVE: To calculate a revised estimate of direct and indirect costs associated with FASD at the patient level. METHODS: Cross-sectional study design was used. Two-hundred and fifty (250) participants completed the study tool. Participants included caregivers of children, youth and adults, with FASD, from day of birth to 53 years, living in urban and rural communities throughout Canada participated. Participants completed the Health Services Utilization Inventory (HSUI). Key cost components were elicited: direct costs: medical, education, social services, out-of-pocket costs; and indirect costs: productivity losses. Total average costs per individual with FASD were calculated by summing the costs for each in each cost component, and dividing by the sample size. Costs were extrapolated to one year. A stepwise multiple regression analysis was used to identify significant determinants of costs and to calculate the adjusted annual costs associated with FASD. RESULTS: Total adjusted annual costs associated with FASD at the individual level was $21,642 (95% CI, $19,842; $24,041), compared to $14,342 (95% CI, $12,986; $15,698) in the first study. Severity of the individual's condition, age, and relationship of the individual to the caregiver (biological, adoptive, foster) were significant determinants of costs (p < 0.001). Cost of FASD annually to Canada of those from day of birth to 53 years old, was $5.3 billion (95% CI, $4.12 billion; $6.4 billion). CONCLUSIONS: Study results demonstrated the cost burden of FASD in Canada was profound. Inclusion of infants aged 0 to 1 years, adults beyond the age of 21 years and costs associated with residing in institutions provided a more accurate estimate of the costs of FASD. Implications for practice, policy, and research are discussed. Key words: Alcohol, pregnancy, cost, economic burden, fetal alcohol spectrum disorder.

Cultural differences and parental responses to the preterm infant at risk: strategies for supporting families.

Parenting a preterm infant at risk for developmental disabilities can be a profoundly stressful experience. For parents from minority cultures, language barriers and cultural differences can increase feelings of uncertainty and inability to cope. Research suggests that cultural differences influence not only parents' emotional responses to and perceptions of disability, but also their utilization of services and their interaction with health professionals. The Neonatal Intensive Care Unit of Mount Sinai Hospital (MSH), Toronto, provides care to a culturally diverse community, and approximately 45 percent of patients receiving care represent minority ethnic groups. Although efforts to provide culturally sensitive care have been made, they have tended to be isolated initiatives lacking consistency and coordination. This article describes the initiation and development of a multicultural program at MSH to support families of infants at risk for developmental disabilities. This article provides valuable guidance to other neonatal units that are attempting to support parents from diverse cultural groups.