Pediatric Academic Societies Research Articles

Acute harm: unplanned extubations and cardiopulmonary resuscitation in children and neonates

Dear Editor, Invasive mechanical ventilation is a common therapy used for children and infants in the intensive care unit (ICU). The impact of unplanned extubation (UE) on morbidity and mortality in adults is well described [1, 2]. There remains a paucity of data related to the cardiovascular morbidity associated with UE events in children. Following review and approval by the institutional review board in accordance and compliance with international ethics standards, we performed a retrospective database review of all UE events in patients admitted to the neonatal, pediatric or cardiac ICU at our institution between July 2011 and December 2012. UE was defined as the removal of an endotracheal tube in a mechanically ventilated patient which was not directed or ordered by a licenced independent practitioner. Cardiovascular collapse was defined as the need for cardiopulmonary resuscitation (e.g., external chest compressions) or circulatory dysfunction immediately following the UE event. Patients with tracheostomies were excluded from our analysis. Preliminary data were presented at the Pediatric Academic Societies’ and Asian Society for Pediatric Research Joint Meeting in Denver, Colorado in 2011 [3]. There were 119 UE events involving 95 unique patients, and the UE rate (events/100 ventilator days) was 0.5. Cardiovascular collapse occurred in 24 events (20 %), of which 20 involved initiation of cardiopulmonary resuscitation. Four events were characterized by circulatory dysfunction requiring immediate re-intubation without initiation of cardiopulmonary resuscitation. There was no immediate mortality associated with these events. We compared UE event characteristics stratified by presence or absence of cardiovascular collapse (Table 1). Immediate re-intubation was performed in 75 (63 %) events and was more likely in patients with cardiovascular collapse (p = 0.01). Cardiovascular collapse was more likely in younger patients (p = 0.048). It has been recognized for some time that UE carries with it significant morbidity increasing the risk of nosocomial infection and length of mechanical ventilation and ICU stay [1]. This is the first study that we are aware of that assesses the frequency of cardiovascular morbidity associated with UE in children. While much of the cardiovascular morbidity occurred in our neonatal population, our data suggest that unplanned extubations in critically ill children and neonates can lead to previously unrecognized morbidity. Despite recent advances in cardiopulmonary resuscitation and extracorporeal membrane oxygenation, in-hospital cardiac arrest portends poor outcomes with survival to discharge rates hovering around 25 % [4]. Our study is limited by the lack of long-term followup data to assess the impact of UE on mortality. However, our data do suggest there is potential for increased mortality associated with UE events. In conclusion, the frequency of cardiovascular morbidity in children

Lactase treated feeds to promote growth and feeding tolerance in preterm infants

Successful transition from parenteral nutrition to full enteral feedings during the immediate neonatal period is associated with improved growth in preterm infants. Lactase is the last of the major intestinal disaccharidases to develop in preterm infants. Because of inadequate lactase activity, preterm infants are unable to digest lactose. Lactase preparations could potentially be used to hydrolyse lactose in formulas and breast milk to minimize lactose malabsorption in preterm infants. To assess the effectiveness and safety of the addition of lactase to milk compared to placebo or no intervention for the promotion of growth and feeding tolerance in preterm infants. weight gain expressed as grams/kg/day, growth expressed as weight, length and head circumference percentile for postmenstrual age (PMA), assessed at birth and at 40 weeks PMA, days to achieve full enteral feeds. several common outcomes associated with preterm birth, and adverse effects. Electronic and manual searches were conducted in January 2005 of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2004, Issue 4), MEDLINE (1966 to Jan 2005), EMBASE (1980 to Jan 2005) and CINAHL (1982 to Jan 2005), personal files, bibliographies of identified trials and abstracts by the Pediatric Academic Societies' Meetings and the European Society of Pediatric Research Meetings published in Pediatric Research. The searches were repeated in May 2012 of The Cochrane Library, MEDLINE, EMBASE and CINAHL and abstracts from the Pediatric Academic Societies' Annual Meetings from 2000 to 2012 (Abstracts2View). The Web of Science was searched using the only previously identified trial by Erasmus 2002 as the starting point to search for additional trials that cited this trial. Types of studies: randomized or quasi-randomized controlled trials. preterm infants < 37 weeks PMA. addition of lactase to milk versus placebo or no intervention. The standard methods of the Cochrane Neonatal Review Group were followed independently by the review authors to assess study quality and report outcomes. Treatment effects, calculated using Review Manager 5, included risk ratio (RR), risk difference (RD) and mean difference (MD), all with 95% confidence intervals (CI). A fixed-effect model was used for meta-analyses. We did not perform heterogeneity tests as only one study was identified. The repeat searches conducted in May 2012 did not identify any additional studies for inclusion. One study enrolling 130 infants of 26 to 34 weeks PMA (mean postnatal age at entry 11 days) was identified and no identified study was excluded. The study was a double blind randomized controlled trial of high quality. Lactase treated feeds were initiated when enteral feedings provided > 75% of daily intake. None of the primary outcomes outlined in the protocol for this review and only one of the secondary outcomes, necrotizing enterocolitis (NEC) were reported on. The RR for NEC was 0.32 (95% CI 0.01 to 7.79); the RD was -0.02 (95% CI -0.06 to 0.03) (a reduction which was not statistically significant). There was a statistically significant increase in weight gain at study day 10 in the lactase treated feeds group but not at any other time points. Overall, there was not a statistically significant effect on weight gain. No adverse effects were noted. The only randomized trial to date provides no evidence of significant benefit to preterm infants from adding lactase to their feeds. Further research regarding effectiveness and safety are required before practice recommendations can be made. Randomized controlled trials comparing lactase versus placebo treated feeds and enrolling infants when enteral feeds are introduced are required. The primary and secondary outcomes for effectiveness and safety should include those identified in this review.

Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants

A patent ductus arteriosus (PDA) with significant left to right shunt increases morbidity and mortality in preterm infants. Early closure of the ductus arteriosus may be achieved pharmacologically or by surgery. The preferred initial treatment of a symptomatic PDA, surgical ligation or treatment with indomethacin, is not clear. To compare the effect of surgical ligation of PDA versus medical treatment with cyclooxygenase inhibitors (indomethacin, ibuprofen or mefenamic acid), each used as the initial treatment, on neonatal mortality in preterm infants with a symptomatic PDA. For this update we searched The Cochrane Library 2012, Issue 2, MEDLINE, EMBASE, CINAHL, Clinicaltrials.gov, Controlled-trials.com, Proceedings of the Annual Meetings of the Pediatric Academic Societies (2000 to 2011) (Abstracts2View(TM)) and Web of Science on 8 February 2012. Randomised or quasi-randomised trials in preterm or low birth weight neonates with symptomatic PDA and comparing surgical ligation with medical treatment with cyclooxygenase inhibitors, each used as the initial treatment for closure of PDA. The authors independently assessed methodological quality and extracted data for the included trial. We used RevMan 5.1 for analyses of the data. One study reporting on 154 neonates was found eligible. No significant difference between surgical closure and indomethacin treatment was found for in-hospital mortality, chronic lung disease, necrotising enterocolitis, sepsis, creatinine level or intraventricular haemorrhage. There was a significant increase in the surgical group in the incidence of pneumothorax (risk ratio (RR) 2.68; 95% confidence interval (CI) 1.45 to 4.93; risk difference (RD) 0.25; 95% CI 0.11 to 0.38; number needed to treat to harm (NNTH) 4 (95% CI 3 to 9)) and retinopathy of prematurity stage III and IV (RR 3.80; 95% CI 1.12 to 12.93; RD 0.11; 95% CI 0.02 to 0.20; NNTH 9 (95% CI 5 to 50)) compared to the indomethacin group. There was a statistically significant decrease in failure of ductal closure rate in the surgical group as compared to the indomethacin group (RR 0.04; 95% CI 0.01 to 0.27; RD -0.32; 95% CI -0.43 to -0.21, number needed to treat to benefit (NNTB) 3 (95% CI 2 to 4)). No new trials were identified for inclusion in the 2012 update. There are insufficient data to conclude whether surgical ligation or medical treatment with indomethacin is preferred as the initial treatment for symptomatic PDA in preterm infants.

Vasopressin and its analogues for the treatment of refractory hypotension in neonates

Neonatal hypotension that is refractory to volume expansion, catecholamines, or corticosteroids has a mortality of about 50%. Optimization of blood pressure and tissue perfusion in refractory hypotension may be crucial to improve clinical outcomes. Vasopressin, a neuropeptide hormone, or its analogue terlipressin has been used to treat refractory hypotension in neonates and may be effective. Our primary objective was to evaluate the efficacy and safety of vasopressin and its synthetic analogues (e.g. terlipressin) in decreasing mortality and adverse neurodevelopmental outcomes, and improving survival in neonates with refractory hypotension. Our secondary objectives were to determine the effects of vasopressin and its analogues (terlipressin) on improvement in blood pressure, increase in urine output, decrease in inotrope score, necrotizing enterocolitis (NEC), periventricular leukomalacia, intraventricular hemorrhage, chronic lung disease, and retinopathy of prematurity (ROP) in neonates with refractory hypotension. We searched the literature in January 2012, using the search strategy recommended by the Cochrane Neonatal Group. We searched electronic databases (CENTRAL (The Cochrane Library), MEDLINE, CINAHL, EMBASE), abstracts of the Pediatric Academic Societies, web sites for registered trials at www.clinicaltrials.gov and www.controlled-trials.com and in the reference list of identified articles. Randomized or quasi-randomized trials evaluating vasopressin or its analogues, at any dosage or duration used as an adjunct to standard therapy (any combination of volume expansion, inotropic agents and corticosteroids) to treat refractory hypotension in neonates. We followed the standard methods of The Cochrane Collaboration for conducting a systematic review. Two review authors (BS and MP) independently assessed the titles and abstracts of studies identified by the search strategy for eligibility for inclusion. We obtained the full text version if eligibility could not be done reliably by title and abstract. We resolved any differences by mutual discussion. We designed electronic forms for trial inclusion/exclusion, data extraction, and for requesting additional published information from authors of the original reports. Our search did not identify any completed or ongoing trials that met our inclusion criteria. Three studies that did not include neonates and one study where the objective was not to treat neonates with refractory hypotension were excluded. There is insufficient evidence to recommend or refute the use of vasopressin or its analogues in the treatment of refractory hypotension in neonates. Well-designed, adequately powered, randomized controlled studies are necessary to address efficacy, optimal dosing, safety and long-term neurodevelopmental and pulmonary outcomes.

NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials

The "synactive" theory of neurobehavioral development forms the basis of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). Our objective was to assess the effectiveness of NIDCAP in improving outcomes in preterm infants. Medline, CINAHL, Embase, PsychInfo, The Cochrane Library, Pediatric Academic Societies' Abstracts and Web of Science were searched in July 2010 and February 2012. The studies selected were randomized controlled trials testing the effectiveness of NIDCAP on medical and neurodevelopmental outcomes. The authors abstracted baseline characteristics of infants and outcomes. The risk of bias was assessed by using Cochrane criteria. RevMan 5.1 was used to synthesize data by the use of relative risk and risk difference for dichotomous outcomes and mean or standardized mean difference for continuous outcomes. Eleven primary and 7 secondary studies enrolling 627 neonates were included, with 2 of high quality. The composite primary outcomes of death or major sensorineural disability at 18 months corrected age or later in childhood (3 trials, 302 children; relative risk 0.89 [95% confidence interval 0.61 to 1.29]) and survival free of disability at 18 months corrected age or later in childhood (2 trials, 192 infants; relative risk 0.97 [95% confidence interval 0.69 to 1.35]), were not significantly different between the NIDCAP and control groups. With the sensitivity analysis that excluded the 2 statistically heterogeneous outlying studies, there were no significant differences between groups for short-term medical outcomes. This systematic review including 627 preterm infants did not find any evidence that NIDCAP improves long-term neurodevelopmental or short-term medical outcomes.

Jean-Pierre Chanoine: taking paediatric endocrinology global

Jean-Pierre Chanoine: taking paediatric endocrinology global

Qualitative Abstracts at the Pediatric Academic Societies Meeting: Are They Less Likely to be Accepted for Presentation?

ObjectiveTo determine the proportion of abstracts submitted to the 2010 Pediatric Academic Societies (PAS) meeting that were exclusively qualitative, and to examine whether these abstracts were more or less likely than all others to be designated as platform, poster, or publish only. MethodsThe database of abstracts submitted to the 2010 PAS meeting was searched using qualitative terms. Authors reviewed abstracts to identify exclusively qualitative abstracts. The proportions and mean score ± standard deviation for qualitative abstracts and those designated platform, poster, or publish only were calculated. Student's t test was used to analyze mean differences; pairwise comparisons and odds ratios (ORs) were used to examine differences in the disposition of qualitative versus all other abstracts. The main outcome was the proportion of abstracts designated as platform, poster, or publish only. ResultsOf 4057 abstracts, 1.6% used only qualitative methods. Scores for qualitative and all other abstracts were 4.26 ± 0.60 and 3.88 ± 0.92, respectively (P < .001). The disposition of qualitative abstracts among platform, poster, and publish only differed from all other abstracts (P = .04). Compared with all others, qualitative abstracts had lower odds of platform presentation (OR 0.36; 95% confidence interval [CI] 0.15–0.91), demonstrated a nonsignificant trend toward publish only (OR 1.6; 95% CI 0.95–2.7), and were equally likely to be posters (OR 1.1; 95% CI 0.65–1.8). ConclusionsCompared with all other abstracts, qualitative abstracts were about 3 times less likely to be chosen for platform presentations; in addition, they demonstrated a trend toward greater odds of publish only. These findings may be the result of inferior quality or an inadequate review process.

Clinical Detoxification: Elimination of Persistent Toxicants from the Human Body

Clinical Detoxification: Elimination of Persistent Toxicants from the Human Body

An Agenda for Children for the 113th Congress: Recommendations From the Pediatric Academic Societies

The 113th Congress of the United States begins in January 2013. With each new Congress, there are many changes, not only in the faces of the newly elected, but also in the membership of committees and the staff serving the members. As agendas for the session are set, there is a resurgence of conflicting priorities. In the past, when these conflicts were resolved, children were rarely at the top of the list. Given the numerous pressing national issues, both domestic and foreign, the same trend will likely occur.

Efficacy and Safety of Acupuncture in Preterm and Term Infants

The aim of the paper was to review the literature about safety and efficiency of acupuncture therapy in term and preterm infants. We searched Medline, EMBASE, and Cochrane Central Register of Controlled Trials using a predefined algorithm, reviewed abstracts from the Pediatric Academic Society annual meetings (2000–2012), and performed a manual search of references in narrative and systematic reviews. A total of 26 studies identified met our search criteria. Only 6 of these studies met our inclusion criteria; however, two studies had to be excluded because the manuscripts were published in Chinese. Hence, only four studies were included in our analysis. Three of the four studies evaluated the effects of acupuncture on infantile colic, and one assessed pain reduction during minor painful procedures in preterm babies. The limited data available suggests that acupuncture could be a safe nonpharmacologic treatment option for pain reduction in term and preterm infants and could also be a non-pharmacologic treatment option to treat infantile colic. Currently acupuncture in infants should be limited to clinical trials and studies evaluating short- and long-term effects and should be performed only by practitioners with adequate training and experience in neonatal/pediatric acupuncture.

Changing the Conversation Regarding Pediatric Cholesterol Screening

Changing the Conversation Regarding Pediatric Cholesterol Screening

Early versus late erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants

Low plasma levels of erythropoietin (EPO) in preterm infants provide a rationale for the use of EPO to prevent or treat anaemia. To assess the effectiveness and safety of early versus late initiation of EPO in reducing red blood cell (RBC) transfusions in preterm and/or low birth weight (LBW) infants. The standard search of the Cochrane Neonatal Review Group (CNRG) was performed in 2006 and updated in 2009. Updated search in September 2009 as follows: The Cochrane Library, MEDLINE (search via PubMed), CINAHL and EMBASE were searched from 2005 to September 2009. The searches were repeated in March 2012. The Pediatric Academic Societies' Annual meetings were searched electronically from 2000 to 2012 at Abstracts2View(TM) as were clinical trials registries (clinicaltrials.gov; controlled-trials.com; and who.int/ictrp). Randomised or quasi-randomised controlled trials enrolling preterm or LBW infants less than eight days of age. Early initiation of EPO (initiated at less than eight days of age) versus late initiation of EPO (initiated at eight to 28 days of age). The standard methods of the CNRG were followed. Weighted treatment effects included typical risk ratio (RR), typical risk difference (RD), number needed to treat to benefit (NNTB), number needed to treat to harm (NNTH) and mean difference (MD), all with 95% confidence intervals (CI). A fixed-effect model was used for meta-analyses and heterogeneity was evaluated using the I-squared (I(2)) test. No new trials were identified in March of 2012. Two high quality randomised double-blind controlled studies enrolling 262 infants were identified. A non-significant reduction in the 'Use of one or more RBC transfusions' [two studies 262 infants; typical RR 0.91 (95% CI 0.78 to 1.06); typical RD -0.07 (95% CI -0.18 to 0.04; I(2) = 0% for both RR and RD] favouring early EPO was noted. Early EPO administration resulted in a non-significant reduction in the "number of transfusions per infant" compared with late EPO [typical MD - 0.32 (95% CI -0.92 to 0.29)]. There was no significant reduction in total volume of blood transfused per infant or in the number of donors to whom the infant was exposed. Early EPO led to a significant increase in the risk of retinopathy of prematurity (ROP) (all stages) [two studies, 191 infants; typical RR 1.40 (95% CI 1.05 to 1.86); typical RD 0.16 (95% CI 0.03 to 0.29); NNTH 6 (95% CI 3 to 33)]. There was high heterogeneity for this outcome (I(2) = 86% for RR and 81% for RD). Both studies (191 infants) reported on ROP stage ≥ 3. No statistically significant increase in risk was noted [typical RR 1.56 (95% CI 0.71 to 3.41); typical RD 0.05 (-0.04 to 0.14)] There was no heterogeneity for this outcome (0% for both RR and RD). No other important favourable or adverse neonatal outcomes or side effects were reported. The use of early EPO did not significantly reduce the 'Use of one or more RBC transfusions' or the 'Number of transfusions per infant" compared with late EPO administration. The finding of a statistically significant increased risk of ROP (any grade) and a similar trend for ROP stage ≥ 3 with early EPO treatment is of great concern.

1376 Probiotics for Prevention of Necrotizing Enterocolitis in Preterm VLBW Neonates- Systematic Review of Randomised Controlled Trials. (Update 2011)

BackgroundSystematic reviews indicate significantly lower risk of NEC and mortality, and shorter time to full feeds after probiotic supplementation in preterm (Gestation < 33 weeks) VLBW neonates.1–3 Few more RCTs...

Haematological abnormalities in neonatal necrotizing enterocolitis

Objective: Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality in preterm infants born prior to 32 weeks gestation or with a birth weight less than 1500 grams. In this article, we review hematological abnormalities associated with NEC. Methods: A literature search was performed using the databases PubMed, EMBASE, and Scopus, and the electronic archive of abstracts presented at the annual meetings of the Pediatric Academic Societies. Results: Thrombocytopenia, disseminated intravascular coagulation, increased or decreased neutrophil counts, and hemolytic anemia are frequent events in NEC. Conclusions: NEC is associated with several hematological abnormalities, which may play a direct or indirect role in the pathogenesis of gut mucosal injury, and may also carry important prognostic information.

Surfactant for pulmonary haemorrhage in neonates

In the 1960s and 1970s, pulmonary haemorrhage (PH) occurred mainly in full-term infants with pre-existing illness with an incidence of 1.3 per 1000 live births. Risk factors for PH included severity of illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy and the need for assisted ventilation. Presently, PH occurs in 3% to 5% of preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. The cause of PH is thought to be due to rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a PDA and an increase in pulmonary blood flow. Retrospective case reports and one prospective uncontrolled study have shown promising results for surfactant in treating PH. To evaluate the effect of surfactant treatment compared to placebo or no intervention on mortality and morbidities in neonates with PH. For this update The Cochrane Library, Issue 2, 2012; MEDLINE; EMBASE; CINAHL; Clinicaltrials.gov; Controlled-trials.com; proceedings (2000 to 2011) of the Annual Meetings of the Pediatric Academic Societies (Abstracts2View) and Web of Science were searched on 8 February 2012. Randomised or quasi-randomised controlled trials that evaluated the effect of surfactant in the treatment of PH in intubated term or preterm (< 37 weeks) neonates with PH. Infants were included up to 44 weeks' postmenstrual age. The interventions studied were intratracheal instillation of surfactant (natural or synthetic, regardless of dose) versus placebo or no intervention. If studies were identified by the literature search, the planned analyses included risk ratio, risk difference, number needed to treat to benefit or to harm for dichotomous outcomes, and mean difference for continuous outcomes, with their 95% confidence intervals. A fixed-effect model would be used for meta-analyses. The risk of bias for included trials would be assessed. Heterogeneity tests, including the I(2) statistic, would be performed to assess the appropriateness of pooling the data and the results would be reported. No trials were identified. No randomised or quasi-randomised trials that evaluated the effect of surfactant in PH were identified. Therefore, no conclusions from such trials can be drawn. In view of the promising results from studies with less strict study designs than a randomised controlled trial, there is reason to conduct further trials of surfactant for the treatment of PH in neonates.

Rituximab for Children with Immune Thrombocytopenia: A Systematic Review

BackgroundRituximab has been widely used off-label as a second line treatment for children with immune thrombocytopenia (ITP). However, its role in the management of pediatric ITP requires clarification. To understand and interpret the available evidence, we conducted a systematic review to assess the efficacy and safety of rituximab for children with ITP.Methodology/Principal FindingsWe searched MEDLINE, EMBASE, Cochrane Library, CBM, CNKI, abstract databases of American Society of Hematology, American Society of Clinical Oncology and Pediatric Academic Society. Clinical studies published in full text or abstract only in any language that met predefined inclusion criteria were eligible. Efficacy analysis was restricted to studies enrolling 5 or more patients. Safety was evaluated from all studies that reported data of toxicity. 14 studies (323 patients) were included for efficacy assessment in children with primary ITP. The pooled complete response (platelet count ≥100×109/L) and response (platelet count ≥30×109/L) rate after rituximab treatment were 39% (95% CI, 30% to 49%) and 68% (95%CI, 58% to 77%), respectively, with median response duration of 12.8 month. 4 studies (29 patients) were included for efficacy assessment in children with secondary ITP. 11 (64.7%) of 17 patients associated with Evans syndrome achieved response. All 6 patients with systemic lupus erythematosus associated ITP and all 6 patients with autoimmune lymphoproliferative syndrome associated ITP achieved response. 91 patients experienced 108 adverse events associated with rituximab, among that, 91 (84.3%) were mild to moderate, and no death was reported.Conclusions/SignificanceRandomized controlled studies on effect of rituximab for children with ITP are urgently needed, although a series of uncontrolled studies found that rituximab resulted in a good platelet count response both in children with primary and children secondary ITP. Most adverse events associated with rituximab were mild to moderate, and no death was reported.

Fostering an Atmosphere of Professionalism in a Residency Program: Learning How to Address the Unprofessional Behavior of Colleagues Through OSCEs

Abstract Introduction Professionalism training and assessment have received much attention. Multiple strategies have been devised to help educational programs deal with unprofessional behavior, whi...

Recombinant human activated protein C for severe sepsis in neonates

Sepsis is a common problem in preterm and term infants. The incidence of neonatal sepsis has declined, but mortality remains high. Recombinant human activated protein C (rhAPC) possess a broad spectrum of activity modulating coagulation and inflammation. In septic adults it may reduce mortality, but no significant benefit has been reported in children with severe sepsis. To determine whether treatment with rhAPC reduces mortality and/or morbidity in neonatal sepsis. For this update searches were carried out in May 2011 of the Cochrane Central Register of Controlled Trials (The Cochrane Library), MEDLINE, EMBASE, CINAHL, and abstracts of annual meetings of the Pediatric Academic Societies. Doctoral dissertations, theses and the Science Citation Index for articles on activated protein C were searched. No language restriction was applied. Randomized or quasi-randomized trials, assessing the efficacy of rhAPC compared to placebo or no intervention as an adjunct to antibiotic therapy of suspected or confirmed severe sepsis in term and preterm infants less than 28 days old. Eligible trials should report at least one of the following outcomes: mortality during initial hospital stay, neurodevelopmental assessment at two years of age or later, length of hospital stay, duration of ventilation, chronic lung disease, periventricular leukomalacia, intraventricular haemorrhage, necrotizing enterocolitis, bleeding, and any other adverse events. Review authors were to independently evaluate the articles for inclusion criteria and quality, and abstract information for the outcomes of interest. Differences were to be resolved by consensus. The statistical methods were to include relative risk, risk difference, number needed to treat to benefit or number needed to treat to harm for dichotomous and weighed mean difference for continuous outcomes reported with 95% confidence intervals. A fixed effect model was to be used for meta-analysis. Heterogeneity tests, including the I(2) statistic, were to be performed to assess the appropriateness of pooling the data. No eligible trials were identified. In October 2011 rhAPC (Xigris®) was withdrawn from the market by Eli Lilly due to a higher mortality in a trial among adults. Xigris® (DrotAA)( rhAPC) should no longer be used in any age category and the product should be returned to the distributor. Despite the scientific rationale for its use, there is insufficient data to use rhAPC for the management of severe sepsis in newborn infants. Due to the results among adults with lack of efficacy, an increase in bleeding and resulting withdrawal of rhAPC from the market, neonates should not be treated with rhAPC and further trials should not be conducted.

Educator Evaluation Guidelines

Abstract Too often, educators are disadvantaged in the promotion and tenure process because their roles are not well understood by committees, and methods to evaluate educator performance have not ...

Corticosteroids for treating hypotension in preterm infants

Systemic hypotension is a relatively common complication of preterm birth and is associated with periventricular haemorrhage, periventricular white matter injury and adverse neurodevelopmental outcome. Corticosteroid treatment has been used as an alternative or an adjunct to conventional treatment with volume expansion and vasopressor/inotropic therapy. To determine the effectiveness and safety of corticosteroids used either as primary treatment of hypotension or for the treatment of refractory hypotension in preterm infants. Randomized or quasi-randomised controlled trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2011), MEDLINE (1996 to Jan 2011), EMBASE (1974 to Jan 2011), CINAHL (1981 to 2011), reference lists of published papers and abstracts from the Pediatric Academic Societies and the European Society for Pediatric Research meetings published in Pediatric Research (1995 to 2011). We included all randomised or quasi-randomised controlled trials investigating the effect of corticosteroid therapy in the treatment of hypotension in preterm infants (< 37 weeks gestation) less than 28 days old. Studies using corticosteroids as primary treatment were included as well as studies using corticosteroids in babies with hypotension resistant to inotropes/pressors and volume therapy. We included studies comparing oral/intravenous corticosteroids with placebo, other drugs used for providing cardiovascular support or no therapy in this review. Methodological quality of eligible studies was assessed according to the methods used for minimising selection bias, performance bias, attrition bias and detection bias. Studies that evaluated corticosteroids (1) as primary treatment for hypotension or (2) for refractory hypotension unresponsive to prior use of inotropes/pressors and volume therapy, were analysed using separate comparisons. Data were analysed using the standard methods of the Neonatal Review Group using Rev Man 5.1.2. Treatment effect was analysed using relative risk, risk reduction, number needed to treat for categorical outcomes and weighted mean difference for outcomes measured on a continuous scale, with 95% confidence intervals. Four studies were included in this review enrolling a total of 123 babies. In one study, persistent hypotension was more common in hydrocortisone treated infants as compared to those who received dopamine as primary treatment for hypotension (RR 8.2, 95% CI 0.47 to 142.6; RD 0.19, 95% CI 0.01 to 0.37). In two studies comparing steroid versus placebo, persistent hypotension (defined as a continuing need for inotrope infusion) was less common in steroid treated infants as compared to controls who received placebo for refractory hypotension (RR 0.35, 95% CI 0.19 to 0.65; RD -0.47, 95% CI - 0.68 to - 0.26; NNT = 2.1, 95% CI 1.47, 3.8). There were no statistically significant effects on any other short or long-term outcome. A further two studies that have only been published in abstract form to date, may be eligible for inclusion in a future update of this review. Hydrocortisone may be as effective as dopamine when used as a primary treatment for hypotension. But the long term safety data on the use of hydrocortisone in this manner is unknown.Steroids are effective in treatment of refractory hypotension in preterm infants without an increase in short term adverse consequences. However, long term safety or benefit data is lacking. With long term benefit or safety data lacking steroids cannot be recommended routinely for the treatment of hypotension in preterm infants.