Events In Newborns Research Articles

Maternal and fetal outcomes among pregnant women with endometriosis.

Endometriosis, a condition in which endometrial-like tissue grows outside of the uterus, is a common disorder among women of reproductive-age. The objective of the study is to examine the associations between endometriosis in pregnancy and adverse maternal and newborn events. Data from the 1999-2019 Healthcare Cost and Utilization Project, Nationwide Inpatient Sample, which is from the United States, were used to perform a retrospective cohort study. Associations between endometriosis and maternal and newborn outcomes were examined using multivariate logistic regression models adjusted for baseline maternal characteristics. We identified 14,956 individuals with endometriosis and 16,911,497 individuals without endometriosis. The prevalence of endometriosis in pregnancy rose substantially from 34.9 to 160.6 per 100,000 births between 1999 and 2019. Individuals with endometriosis were more likely older in age, of Caucasian ethnicity, belonged to higher income quartiles, had private insurance, smoked, and were obese. Endometriosis in pregnancy was associated with greater odds of pre-eclampsia, gestational diabetes, placenta previa, placental abruption, preterm birth, chorioamnionitis, and postpartum hemorrhage. Growth restriction and congenital anomalies were more frequent among newborns born to individuals with endometriosis. Endometriosis in pregnancy renders individuals and their newborns at greater risk for poor outcomes in pregnancy. Hence, it is prudent for obstetrical care providers to be aware of the adverse events associated with endometriosis and to closely follow the pregnancies of women with this condition.

The Risk of Withdrawal Seizures & Other Adverse Events in Newborns Associated with Levetiracetam Use as Monotherapy or in Combination Therapy for Seizures During Pregnancy - A Systematic Review

The Risk of Withdrawal Seizures & Other Adverse Events in Newborns Associated with Levetiracetam Use as Monotherapy or in Combination Therapy for Seizures During Pregnancy - A Systematic Review

The impact of shared governance on the adverse mood of parturients with gestational hypertension and perinatal indicators of newborns

This study aimed to investigate the effect of shared governance on the adverse mood of parturients with gestational hypertension and perinatal indicators of newborns. A total of 318 patients with gestational hypertension treated in our hospital were enrolled as study subjects and were divided into a study group (200 cases) and a control group (118 cases) using double-blind, controlled and randomised methods. Before intervention, the systolic blood pressure (SBP), diastolic blood pressure (DBP), Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD) and Quality of Life Scale (SF-36) scores did not differ significantly between the two groups (p>.05). After intervention, the study group had lower SBP, DBP, HAMA and HAMD scores and higher SF-36 scores than the control group (p<.05). The neonates in the study group experienced a lower incidence of adverse outcomes than those in the control group (p<.05). Shared governance can regulate blood pressure and improve mood and quality of life in parturients with gestational hypertension. It can also reduce the incidence of adverse events in newborns during the perinatal period. Impact Statement What is already known on this subject? Gestational hypertension is the development of hypertension in pregnant women after 2 or 20 weeks of gestation and is characterised by headache, dizziness, nausea and swelling of the lower legs. Early intervention is key to improving maternal and neonatal prognosis. Shared governance is an emerging model of participatory decision-making in which nurses are empowered to make decisions about clinical practice standards, quality improvement, staff and professional development, and research, aiming to cultivate the patients' sense of responsibility for their health. What do the results of this study add? This study demonstrated that shared governance can regulate maternal blood pressure and improve maternal adverse mood, maternal quality of life and reduce the incidence of perinatal adverse events in the newborn, indicating the potential of shared governance and may promote the clinical application of shared governance. What are the implications of these findings for clinical practice and/or further research? This study starts with adverse mood of parturients and perinatal outcomes of newborns, and demonstrates in detail the impact of shared governance in nursing interventions on parturients with gestational hypertension and neonates. The data are detailed and reliable, providing certain clinical references for follow-up research.

Pregnancy outcomes following maternal or paternal exposure to teriflunomide in the Danish MS population

Background Teriflunomide (TFL) is an oral drug used for treatment of multiple sclerosis (MS). Due to possible teratogenicity it is contraindicated in women of childbearing potential. Additionally, a low risk of male-mediated embryo-fetal toxicity has been described as the drug can be transmitted via semen. This study investigated the association of adverse perinatal outcomes in newborns with either maternal or paternal exposure to TFL.Methods The Danish Multiple Sclerosis Registry was used to identify all patients treated with teriflunomide from 1st of September 2013 to 31st of December 2018. Data were merged with other nationwide national registries to identify all pregnancies with potential exposure to TFL. Exposure was defined as conception occurring after at least 30 consecutive days of treatment either during treatment or within two years of treatment discontinuation. Exposed pregnancies were matched 1:4 with controls from the general population. Individual outcomes of adverse perinatal events, namely preterm birth, congenital malformations, small for gestational age (SGA), stillbirth or low Apgar score were used to form a composite outcome, any adverse event, which was used for the analysis. Logistic regression was used to estimate the association of having any adverse event in newborns with either maternal or paternal exposure to TFL.Results A total of 112 TFL-exposed pregnancies were included of which 49 had maternal exposure and 63 paternal exposure. Among women, 21/49 pregnancies were terminated – 18 electively and three spontaneously. The remaining 28 pregnancies resulted in healthy newborns of which ≤3 were preterm. None of the newborns presented with malformations, being SGA or with low Apgar score. Among men, all 63 pregnancies resulted in birth of which 4/63 (6.3%) were preterm. Major malformations were registered in ≤3 event, and no newborn presented with low Apgar score or being SGA. No increased association of any adverse event was found in newborns with TFL exposure relative to controls (OR 1.03, 95% CI 0.50–2.13).Conclusion We did not find an increased prevalence of spontaneous abortion, preterm birth, congenital malformations, low Apgar score of being SGA in newborns with maternal or paternal exposure to TFL when compared with the general population. However, the sample was too small to draw firm conclusions.

Multiscale Entropy Analysis of Heart Rate Variability in Neonatal Patients with and without Seizures.

The complex physiological dynamics of neonatal seizures make their detection challenging. A timely diagnosis and treatment, especially in intensive care units, are essential for a better prognosis and the mitigation of possible adverse effects on the newborn’s neurodevelopment. In the literature, several electroencephalographic (EEG) studies have been proposed for a parametric characterization of seizures or their detection by artificial intelligence techniques. At the same time, other sources than EEG, such as electrocardiography, have been investigated to evaluate the possible impact of neonatal seizures on the cardio-regulatory system. Heart rate variability (HRV) analysis is attracting great interest as a valuable tool in newborns applications, especially where EEG technologies are not easily available. This study investigated whether multiscale HRV entropy indexes could detect abnormal heart rate dynamics in newborns with seizures, especially during ictal events. Furthermore, entropy measures were analyzed to discriminate between newborns with seizures and seizure-free ones. A cohort of 52 patients (33 with seizures) from the Helsinki University Hospital public dataset has been evaluated. Multiscale sample and fuzzy entropy showed significant differences between the two groups (p-value < 0.05, Bonferroni multiple-comparison post hoc correction). Moreover, interictal activity showed significant differences between seizure and seizure-free patients (Mann-Whitney Test: p-value < 0.05). Therefore, our findings suggest that HRV multiscale entropy analysis could be a valuable pre-screening tool for the timely detection of seizure events in newborns.

New Perspectives and Challenges Regarding Fertility, Conception and Pregnancy in Hemoglobinopathies. a Multidisciplinary Report of 66 Outcomes

Introduction Major thalassemia (TM) and sickle cell disease (SCD), two common genetic hemoglobinopathies, were often fatal 50 years ago. Novel therapeutic and diagnostic methods are increasing lifespan and quality of life. Recent advances in iron chelation for transfusion-dependent hemoglobinopathies have significant improved patient prognosis. Young adult TM and SCD patients often ask about the possibility of conception and pregnancy. The increase in the worldwide movement of carriers and subjects has lead to new cultural, ethical and psychosocial aspects that must be taken into consideration. The present study investigated the fertility rate, maternity/paternity status, need for assisted reproductive techniques (ART), abortion rate, pregnancy/newborn complications in patients with hemoglobinopathies. Methods We followed 130 female (FPs) and male (MPs) patients (F:M=93:37); 75 with TM, 32 with thalassemia intermedia (TI), 13 with SCD and 10 with microdrepanocytosis (MDC). Median age is 55 yo (15-90) for TM+TI and 45 yo (18-79) for SCD+MDC. Pregnancy was reported in 37/52 FP of childbearing age (15-49 yo), and conception in 15 MP with fertility rates of 71% and 70%, respectively. Results We reviewed 66 conceptions from 1999 to 2020. Mother age at pregnancy was between 32-39 yo. Forty-seven pregnancies were spontaneous and 19 medically assisted. There were 3 ovodonations and 2 ICSI; 64% of pregnancies were planned. Pregnancy outcomes of 22 TM, 16 TI, 8 SCD and 3 MDC patients are described. There were 7 miscarriages in the first 12 weeks: 3 in TI, 1 in SCD FP; 1 in TM and 2 in SCD MP. Abortion rate was 9%, comparable to the general population. Intrauterine death at 24w occurred in a SCD FP for placental thrombosis and eclampsia. Sixty live healthy newborns were delivered;4 twin pregnancies occurred (1 TM MP, 3 TM FP). Only 1 malformation was observed, in an infant born after ovodonation in a TM FP who had minor gastroenteric and urinary malformations that were surgically corrected. Obstetric complications were eclampsia, disseminated intravascular coagulation, cardiac failure, and acute chest syndrome in SCD patients. One ovarian hyperstimulation syndrome in the 1st month of pregnancy with ascites and admission to the ER was reported. There were 30 (94%) caesarians (CD) and 3 vaginal deliveries (VG) in FP, with 7 preterm babies (22%). In partners of MPs there were 15 CD (56%), and 11 VG with 5 preterm babies (Table I). Births from MPs occurred between 34-40w with a median birth weight of 3 kg (2.17-4) and 30-41w in FPs with a median birth weight of 2,5 kg (1,1-3,4) . FPs were able to breast fed in 56% of cases for a medium time of 66 days (20-120), while female partners of MPs breastfed for 193 days (20-540). Newborn events includes 14 jaundices; 9 babies were placed in intensive care and required incubator use due to cerebral hemorrhage or infections requiring antibiotic therapy. Discussion Spontaneous pregnancies occur in well chelated and transfused patients but a relevant part of those patients are infertile due to hypogonadism due to transfusional hemosiderosis and may need ART. These patients present a base-line pro-coagulant state which can worsen during pregnancy, needing antithrombotic prophylaxis and require regular consultations, since pregnancies are considered high risk for both mother and baby. As osteopenia-osteoporosis are the common endocrine complications in hemoglobinopathies (67% of FPs), both cesarean delivery and breast feeding are strongly suggested. Even though chelating therapy during lactation does not alter iron excretion, our patients didn't receive chelating therapy when breastfeeding. Multidisciplinary programs including transfusions, cardiac and clinical evaluations should be monthly performed. Our Institution has a team of hematologists and other dedicated specialists that work together during the planning, conception, pregnancy, delivery and immediate post-delivery processes to assure best care to mother and child. Conclusions Survival of hemoglobinopathic patients in developed countries is improving and patients aspire to reproductive aims of their healthy peers. TM and SCD patients often request fertility and pregnancy information, including screening of partners. We provide insights regarding reproductive health experience of hemoglobinopathies in both genders. Detailed results, mothers and child follow up and practical management will be presented. Figure Disclosures Abruzzese: Incyte:Consultancy, Membership on an entity's Board of Directors or advisory committees;Pfizer:Consultancy, Membership on an entity's Board of Directors or advisory committees;Novartis:Consultancy, Membership on an entity's Board of Directors or advisory committees;Bms:Honoraria.

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial

ABSTRACT Vaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 − 7.7] vs. 3.4 [95% CI: 2.7 − 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 − 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.

Risk factors associated with adverse events in neonates with peripherally inserted central catheter

BackgroundPeripherally inserted central catheters have become a priority in infants who require long-term intravenous therapy, but their use involves certain risks. ObjectiveThe aim of the study was to describe the occurrence of adverse events in newborns with peripherally inserted central catheters and to determine the risk factors associated with them. MethodsA descriptive cross-sectional study was designed and performed. All neonates with peripherally inserted central catheters from October 1st, 2014 to September 30th, 2015 were included. The adverse events and sociodemographic and clinical variables related to neonates and analysed catheters were recorded. ResultsA total of 140 catheters were placed in 116 infants. All of them were analysed. Adverse events occurred in 16.4%: catheter-associated bacteraemia (5.7%), obstruction (5.7%), extravasation (2.1%) and phlebitis (2.1%), <27 weeks of pregnancy (OR=1.2, p=.02), birth weight <1000g (OR=6.7, p=.02), with catheters in situ for longer than one week (OR=9.8, p=.02) and with perfusion of antibiotics per catheter (OR=1.3, p<.01). Phlebitis is associated with the insertion of the catheter in LL and head (OR=1.1, p=.03). Factors associated with bacteraemia risk with adjusted prevalence odds ratio are extremely low birth weight neonates (OR=6.38; p=.03) and with a catheter in situ for longer than one week (OR=9.41; p=.04). ConclusionsThe periodic evaluation of catheter-related adverse events is very useful to prepare improvement plans. This will maximise safety for the most vulnerable newborns, especially those of extremely low birth weight that require very long treatments.

INTRAVENTRICULAR HEMORRHAGES IN NEONATOLOGY: PREDICTION OF THE LETHAL CASES IN PREMATURE INFANTS

Introduction. Severe intraventricular hemorrhages (IVH) in children born prematurely remain a significant problem of neonatal hospitals and intensive care units throughout the world. The incidence of GIII - IV degree in children with gestational age less than 32 weeks is 25%, the mortality rate among prematurely born children with IVH IV Art. - up to 60%. Previous studies indicate stable mortality rates in a cohort of newborns with severe IVH in the Poltava region during 2009–2017, they remain quite high in both children born with a weight <1000 and among children weighing 1000–1499. ., and significantly higher than in the developed countries of the world. Despite many different clinical studies on the problem of intraventricular hemorrhage, the causes of development, risk factors, as well as prediction of fatal cases in children born prematurely with existing severe IVH remain unclear and debatable.The aim of this work: was to determine the reliable risk factors for the occurrence of lethal cases among premature infants with IVHs and to develop a predictive model of lethal events in premature infants with severe IVH.Materials and methods. A multicentre study was conducted, which included children with III and IV grade of IVHs by Papile classification, the grade of IVHswasestablished during sonography up to 3 days of life. The study group consisted of 76 premature infants: 40 infants (body weight at birth 903,72 ± 56,61 g, GA 26,15 ± 0,34 weeks) who died, and 36 infants (body weight 1187,3 ± 58,0 g, GA 28.09 ± 0,37 weeks) who survived. The definition of risk factors, which are reliably associated with the development of lethal cases in newborns with IVHs, has been carried out. The simple logistic regression analysis was carried out to identify factors that are reliably associated with the development of IVHs in premature infants,these obtained data became a sound tool for inventing a predictive model using multiple logistic analysis and further evaluation of operational characteristics using the STATA 11.0 application package.Research results. Premature infants with IVHs, whosedisease courses ended in lethal cases, had significantly less gestational age (p = 0,001) and body weight at birth (p = 0,003) than prematuresurvivors. Due to the simple regression analysis, there were found associations between the occurrence of the lethal case and GA (OR = 0,66; p = 0,01); tracheal intubation (OR 0.4; p = 0,055); introduction of surfactant in the delivery room (OR = 0.16; p = 0,025); sepsis (OR 3,2; p = 0,027), severe RDS (OR 8,1; p = 0,001), infection (level of CRP) (OR 2.45; p = 0,072), number of WBC (OR1,1; p = 0,01) and platelets (OR 0,99; p = 0,007) on the 6th day of life.The prognostic model of the development of lethal cases was developed, which included the following variables: intubation during resuscitation, severe RDS, number of WBC (x109 / l) and platelets (x109 / l) on the6th day of life, sensitivity - 71,4 %, specificity – 100,0 %, positive predictive value is 100 %, negative predictive value is 76 % and area under the ROC curve is 0,9373.Conclusions. The prognostic model for the development of lethal events in newborns with IVHs, which includes: intubation during resuscitation (β = -4,16), presence of severe RDS (β = 4,4), platelets count (β = -0,02 ) and the level of WBC (β = 0,11) on the 6thday after birth has high operational characteristics.Conclusions. Prognostic model of development of deaths in newborns with IVH, which includes: intubation during resuscitation (β=-4.16), the presence of severe RDS (β=4.4), platelet count (β=-0.02) and the level of leukocytes (β=0.11) on day 6 after birth has high operational characteristics and may be recommended the use of this model in in neonatology practical.

Factores de riesgo asociados a eventos adversos en recién nacidos portadores de catéteres centrales de inserción periférica

BackgroundPeripherally inserted central catheters have become a priority in infants who require long-term intravenous therapy, but their use involves certain risks. ObjectiveThe aim of the study was to describe the occurrence of adverse events in newborns with peripherally inserted central catheters and to determine the risk factors associated with them. MethodsA descriptive cross-sectional study was designed and performed. All neonates with peripherally inserted central catheters from October 1st, 2014 to September 30th, 2015 were included. The adverse events and sociodemographic and clinical variables related to neonates and analyzed catheters were recorded. ResultsA total of 140 catheters were placed in 116 infants. All of them were analyzed. Adverse events occurred in 16.4%: catheter-associated bacteraemia (5.7%), obstruction (5.7%), extravasation (2.1%) and phlebitis (2.1%), <27weeks of pregnancy (OR=1.2, P=.02), birth weight <1000g (OR=6.7, P=.02), with catheters in situ for longer than one week (OR=9.8, P=.02) and with perfusion of antibiotics per catheter (OR=1.3, P<.01). Phlebitis is associated with the insertion of the catheter in LL and head (OR=1.1, P=.03). Factors associated with bacteraemia risk with adjusted prevalence odds ratio are extremely low birth weight neonates (OR=6.38; P=.03) and with a catheter in situ for longer than one week (OR=9.41; P=.04). ConclusionsThe periodic evaluation of catheter-related adverse events is very useful to prepare improvement plans. This will maximize safety for the most vulnerable newborns, especially those of extremely low birth weight that require very long treatments.

Health and gene polymorphisms of the hemostatic system in newborn with thrombotic and ischemic events

The purposeof this study is to reveal the peculiarities of the state, polymorphism of hemostatic genes in newborns with thrombotic and related ischemic events.Materials and methods. The analysis of 40 fixed cards for newborns with thrombosis and isschemic events who were in the offices of GBUZ NSO “Novosibirsk State regional clinical hospital”. A study of indicators of blood coagulation, defined by the carriage of thrombohemorrhagic gene polymorphic variants was conducted. The control group included 30 healthy newborns.Results. The structure of thrombotic complications was analyzed, and a number of ischemic complications were revealed in infants. A statistical analysis was carried out, which allowed the presence of features of hemostatic system in thrombotic and related ischemic events in newborns to be established. The most significant gene polymorphisms found with these complications in the neonatal period of life are revealed.Conclusion. The hemostatic system in children of the considered group is characterized by a high Level of d-dimers, in the neonatal period, Leiden mutation is the most important, thrombotic and ischemic events are more common in children with a combination of several polymorphisms of the genes of the hemostasis system.

Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial.

Background: Probiotic supplementation to women during pregnancy and lactation can modulate breast milk composition, with immune benefits being transferred to their infants. Aim: The aim of the study was to evaluate the effect of high-dose probiotic supplementation to women during late pregnancy and lactation on cytokine profile and secretory IgA (sIgA) in breast milk and thus to study if differences in breast milk composition can affect lactoferrin and sIgA levels in stool samples of newborns. The safety of maternal probiotic administration on neonatal growth pattern and gastrointestinal symptoms were also evaluated. Methods: In a double-blind, placebo-controlled, randomized trial, 66 women took either the probiotic (n = 33) or a placebo (n = 33) daily. Levels of interleukins (IL-6, IL-10 and IL-1β), transforming growth factor-β1 (TGF-β1), and sIgA in breast milk; and the level of sIgA and lactoferrin in newborn stool samples were analyzed at birth and then again at one month of life. Antropometrical evaluation and analysis of gastrointestinal events in newborns was also performed. Results: Probiotic maternal consumption had a significant impact on IL6 mean values in colostrum and on IL10 and TGF-β1 mean values in mature breast milk. Fecal sIgA mean values were higher in newborns whose mothers took the probiotic product than in the control group. Probiotic maternal supplementation seems to decrease incidence of infantile colic and regurgitation in infants. Conclusion: High-dose multi-strain probiotic administration to women during pregnancy influences breast milk cytokines pattern and sIgA production in newborns, and seems to improve gastrointestinal functional symptoms in infants.

Lipopolysaccharide exposure during the early postnatal period adversely affects the structure and function of the developing rat carotid body.

The carotid body (CB) substantially influences breathing in premature infants by affecting the frequency of apnea and periodic breathing. In adult animals, inflammation alters the structure and chemosensitivity of the CB, yet it is not known if this pertains to neonates. We hypothesized that early postnatal inflammation leads to morphological and functional changes in the developing rat CB, which persists for 1 wk after the initial provoking insult. To test our hypothesis, we exposed rat pups at postnatal day 2 (P2) to lipopolysaccharide (LPS; 100 μg/kg) or saline (SAL) intraperitoneally. At P9-10 (1 wk after treatment), LPS-exposed animals had significantly more spontaneous intermittent hypoxic (IH) events, attenuated ventilatory responses to changes in oxygen tension (measured by whole body plethysmography), and attenuated hypoxic chemosensitivity of the carotid sinus nerve (measured in vitro), compared with SAL-exposed controls. These functional changes were associated with the following: 1) increased inflammatory cytokine mRNA levels; 2) decreased volume of supportive type II cells; and 3) elevated dopamine levels (a major inhibitory neuromodulator) within the CB. These findings suggest that early postnatal inflammation in newborn rats adversely affects the structure and function of the CB and is associated with increased frequency of intermittent desaturations, similar to the phenomenon observed in premature infants. Furthermore, this is the first newborn model of spontaneous intermittent desaturations that may be used to understand the mechanisms contributing to IH events in newborns.

Nonepileptic paroxysmal event in newborn: A case report

Nonepileptic paroxysmal event in newborn: A case report

Lidocaine-Associated Cardiac Events in Newborns with Seizures: Incidence, Symptoms and Contributing Factors

Background: Lidocaine is an effective therapy for neonatal seizures; however, it is not widely used, presumably due to the risk of cardiac events. Objective: To investigate the incidence of cardiac events in full-term and preterm infants receiving lidocaine for seizures. Methods: Full-term (n = 368) and preterm (n = 153) infants, admitted to a level 3 neonatal intensive care unit from 1992 to 2012, who received lidocaine for seizures were retrospectively studied. The causal relation between reported cardiac events and lidocaine administration was evaluated based on expected plasma concentrations, symptoms and relevant interactions during cardiac events. Results: Cardiac events were reported in 11/521 infants (2.1%; 9 full-term, 2 preterm). In 7/11 infants the causal relation was considered plausible, in 3/11 questionable and in 1/11 implausible. The incidence was calculated to be 1.3-1.9% (n = 7-10/521), but was only 0.4% (n = 1/246, p = 0.02) when using reduced-dose regimens. Important risk factors for cardiac events were unstable potassium, (congenital) cardiac dysfunction and concurrent phenytoin use. Conclusions: Lidocaine-associated cardiac events were rare in our cohort, especially since the introduction of new reduced-dose regimens. This indicates that lidocaine is safe to use as an antiepileptic drug in full-term and preterm infants.

Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy.

A panel of experts convened by the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, developed proposed guidelines for the evaluation of adverse events in newborns of women participating in clinical trials of maternal immunization in the United States.

PS-054 Vsl#3 Supplementation To Mothers During Pregnancy And Breast Feeding Improves Colics And Regurgitation In Newborns, Perhaps By Tgf-b Modulation

<h3>Aim</h3> To evaluate the influence of maternal supplementation with VSL#3 on digestive events in newborns and cytokines levels in colostrum and mature breast milk. <h3>Methods</h3> This pilot double-blind, randomised, placebo-controlled clinical trial (clinicaltrials.gov:<b>NCT01367470</b>) enrolled four weeks before expected delivery healthy pregnant women that received daily oral VSL#3 (PTM) or placebo (CM) supplementation until four weeks after delivery. In milk samples we measured IL10 and TGFb (with commercial ELISA kits) at birth (T0) and after 30 (T30) days. Stool frequency and consistency (Bristol stool scale), regurgitation/vomiting, colics (Rome III criteria) in newborns were recorded in a weekly diary. Two-way ANOVA for repeated measures, Chi-square test and RR: evaluation of time effect and link between probiotic supplementation and colics/ regurgitation. <h3>Results</h3> 67 mothers/term newborns pairs were enrolled. In 44 milk samples we measured TGFb and IL10 with a significant increase in TGFb from T0 to T30 in PTM and a reduction in CM (interaction effect: F = 10.314 p = 0.005). IL10 was high at T0 and decreased in both groups at T30 (time effect: F = 25.808 p &lt; 0.001). We found an higher frequency of colics and regurgitation in CM with respect to PTM newborns (colics: c² = 7.2 p = 0.007; RR = 4; regurgitations:c² = 6.944 p = 0.008; RR = 2.43). A TGFb modulation of muscarinic receptor involved in controls of intestinal motility could be hypotized. Regarding colics, VSL#3 could be involved in pain perception. <h3>Conclusions</h3> VSL#3 supplementation to mothers during pregnancy and breast feeding may be a powerful immune modulator in terms of TGFb in breast milk, and can influence intestinal motility and pain perception in newborns.

Two cases of neonatal adrenal hemorrhage presenting with persistent jaundice

The adrenal hemorrhage is a relatively rare event in newborns but must be considered in the presence of a persistent unexplained jaundice, especially in presence of predisposing factors. Serial ultrasonography is the modality of choice for initial diagnosis and follow-up of neonatal adrenal hemorrhage. We report two cases of neonatal adrenal hemorrhage presenting with persistent jaundice. The causes of the neonatal adrenal hemorrhages were a difficult vaginal delivery in macrosomic infant and a neonatal infection.

C0160 Neonatal thrombosis: Influence of ethnicity on genetic risk factors

Thrombotic events in newborns (NB) are rare. The most important known risk factor is the presence of central line catheters. Factor V Leiden (FVL) is considered the most frequent genetic risk factor. Spontaneous thrombotic events are less frequent in NB and may involve CNS and Renal Veins (RV). There is no consensus on recommended laboratory workups nor on treatment protocols (Grade 2C). Different ethnic frequency of thrombophilic genetic factors may influence the incidence of thrombotic events in NB.

Congenital malaria in Urabá, Colombia

BackgroundCongenital malaria has been considered a rare event; however, recent reports have shown frequencies ranging from 3% to 54.2% among newborns of mothers who had suffered malaria during pregnancy. There are only a few references concerning the epidemiological impact of this entity in Latin-America and Colombia.ObjectiveThe aim of the study was to measure the prevalence of congenital malaria in an endemic Colombian region and to determine some of its characteristics.MethodsA prospective, descriptive study was carried out in the mothers who suffered malaria during pregnancy and their newborns. Neonates were clinically evaluated at birth and screened for Plasmodium spp. infection by thick smear from the umbilical cord and peripheral blood, and followed-up weekly during the first 21 days of postnatal life through clinical examinations and thick smears.Results116 newborns were included in the study and 80 umbilical cord samples were obtained. Five cases of congenital infection were identified (four caused by P. vivax and one by P. falciparum), two in umbilical cord blood and three in newborn peripheral blood. One case was diagnosed at birth and the others during follow-up. Prevalence of congenital infection was 4.3%. One of the infected newborns was severely ill, while the others were asymptomatic and apparently healthy. The mothers of the newborns with congenital malaria had been diagnosed with malaria in the last trimester of pregnancy or during delivery, and also presented placental infection.ConclusionsCongenital malaria may be a frequent event in newborns of mothers who have suffered malaria during pregnancy in Colombia. An association was found between congenital malaria and the diagnosis of malaria in the mother during the last trimester of pregnancy or during delivery, and the presence of placental infection.