Neonatal Adverse Events Research Articles

Caesarean risk in obese women at term: Aretrospective cohort analysis.

Obesity in pregnancy is a growing health problem conferring higher risk to both the woman and her infant. Internationally, peak bodies offer little guidance regarding the method and timing of delivery in these patients. Our hypothesis is that induction of labour (IOL) at term will not increase the caesarean section (CS) rate when compared to expectant management. To compare perinatal outcomes between IOL and expectant management in obese women at term. A retrospective cohort study of all term, singleton, vertex deliveries at the Townsville Hospital and Health Service from January 2011 to June 2015 in women with a body mass index (BMI) ≥35. Women undergoing IOL at 37weeks were compared with women expectantly managed at that gestational age. Similar comparisons were made at 38, 39 and 40weeks. χ2 tests and binary logistic regression were used for statistical comparison. The primary outcome measure was mode of delivery, with secondary measures of perinatal morbidity also considered. There was no difference in outcome of CS, or other maternal secondary outcomes. There was no difference in rates of neonatal nursery admission. Expectant management at 38weeks was associated with lower odds of post-partum haemorrhage (odds ratio 0.371; 95% confidence interval 0.163-0.845). In women with a BMI ≥35, IOL does not affect the CS rate, or the risk of neonatal adverse events, but may increase the rate of postpartum haemorrhage when compared with expectant management.

Ceftriaxone-Associated Biliary and Cardiopulmonary Adverse Events in Neonates: A Systematic Review of the Literature.

Ceftriaxone is a third-generation cephalosporin with broad-spectrum activity against both Gram-positive and Gram-negative bacteria. Despite its effectiveness, its use for the treatment of infections in neonatal patients has been limited because of concern about its potential toxicity. Our aim was to review the literature for an association between ceftriaxone and cardiopulmonary events, hyperbilirubinemia, and pseudolithiasis among neonates. We searched PubMed and EMBASE and included studies that evaluated ceftriaxone safety in neonates. Study bias was evaluated in the following domains: exposure measurement, outcome measurement, attrition, generalizability, confounding, statistical analysis, and reporting. We included nine studies regarding ceftriaxone side effects, primarily spontaneous reports, published case reports, and small case series. Reports of bilirubin displacement attributed to ceftriaxone included increases in serum bilirubin necessitating antibiotic change in a subset of infants after administration of ceftriaxone. One study described self-resolving biliary sludge after ceftriaxone administration in six of 80 infants. Cardiopulmonary adverse events included a report of eight cardiopulmonary events related to concomitant ceftriaxone-calcium infusion, including seven infant deaths. Additional cardiopulmonary events reported included perinatal asphyxia, pulmonary hypertension, and thrombocytosis. However, the available literature had small sample sizes, poor external validity, and inconsistent outcome ascertainment methods, which made it impossible to estimate the magnitude of risk. Concomitant administration of intravenous ceftriaxone and calcium-containing solutions should be avoided in neonates. However, further controlled studies are needed to assess whether bilirubin displacement associated with the use of ceftriaxone is clinically relevant, particularly in healthy term and near-term neonates with mild hyperbilirubinemia.

Collaborative Care for Perinatal Depression Among Socioeconomically Disadvantaged Women: Adverse Neonatal Birth Events and Treatment Response.

The study examined the effectiveness of a perinatal collaborative care intervention in moderating the effects of adverse neonatal birth events on risks of postpartum depressive symptoms and impaired functioning among women of lower socioeconomic status with antenatal depression. A randomized controlled trial with blinded outcome assessments was conducted in ten public health centers, comparing MOMCare (choice of brief interpersonal psychotherapy, pharmacotherapy, or both) with intensive maternity support services (MSS-Plus). Participants had probable diagnoses of major depressive disorder or dysthymia during pregnancy. Generalized estimating equations estimated differences in depression and functioning measures between groups with and without adverse birth events within the treatment arms. A total of 160 women, 43% of whom experienced at least one adverse birth event, were included in the analyses. For women who received MOMCare, postpartum depression scores (measured with the Symptom Checklist-20) did not differ by whether or not they experienced an adverse birth event (mean±SD scores of .86±.51 for mothers with an adverse birth event and .83±.56 for mothers with no event; p=.78). For women who received MSS-Plus, having an adverse birth event was associated with persisting depression in the postpartum period (mean scores of 1.20±.0.61 for mothers with an adverse birth event and .93±.52 for mothers without adverse birth event; p=.04). Similar results were seen for depression response rates and functioning. MOMCare mitigated the risk of postpartum depressive symptoms and impaired functioning among women of low socioeconomic status who had antenatal depression and who experienced adverse birth events.

Ceftriaxone adverse events in neonates

Ceftriaxone adverse events in neonates

Neonatal Adaptation Issues After Maternal Exposure to Prescription Drugs: Withdrawal Syndromes and Residual Pharmacological Effects.

Exposure to drugs during pregnancy has the potential to harm offspring. Teratogenic effects are the most feared adverse outcomes in newborns; however, a wide spectrum of less known, usually reversible and often acute, neonatal adverse events can also occur due to drug intake by mothers during pregnancy, particularly in close proximity to delivery. This narrative review is aimed at the description of drugs and drug classes for which licit maternal use in the predelivery period has been associated with neonatal non-teratogenic disorders. For each drug class, epidemiology, clinical features, biological mechanism and management of these adverse reactions have been discussed in detail. Although these adverse reactions have been described mainly for substances used illicitly for recreational purposes, several prescription drugs have also been involved; these include mainly psychotropic medications such as opioids, antidepressants, antiepileptics and antipsychotics. These effects can be partly explained by withdrawal syndromes (defined also as 'neonatal abstinence syndrome') caused by the delivery-related discontinuation of the drug disposition from the mother to the fetus, with symptoms that may include feeding disorders, tremors, irritability, hypotonia/hypertonia, vomiting and persistent crying, occurring a few hours to 1month after delivery. Otherwise, neonatal neurological and behavioral effects can also be caused by a residual pharmacological effect due to an accumulation of the drug in the blood and tissues of the newborn, with various symptoms related to the toxic effects of the specific drug class, usually developing a few hours after birth. With few exceptions, validated protocols for the assessment and management of withdrawal or residual pharmacological effects of these drugs in neonates are often lacking or incomplete. Spontaneous reporting of these adverse reactions seems limited, although it might represent a useful tool for improving our knowledge about drug-induced neonatal syndromes.

Use of intravenous immunoglobulin in neonates at a tertiary academic hospital: a retrospective 11-year study.

Intravenous immunoglobulin (IVIG) is used to treat a variety of diseases in the neonatal intensive care unit (NICU). Although audits have reported on the spectrum of IVIG use in adults, the indications and utilization in neonates has not been investigated. The objectives of this study were to describe the usage pattern of and indications for IVIG in a tertiary care NICU. A retrospective chart review was performed of all neonates who received IVIG in the NICU from January 2003 to December 2013. Data collected included patient demographic features, antenatal maternal details, neonatal laboratory results, treatment details, adverse events, and patient outcome. Thirty-seven neonates received IVIG over the 11-year period. Twenty-three (67%) were treated for hemolytic disease of the newborn (HDN); 13 treatments were ABO related, six were anti-D related, and four were for clinically significant antibodies. Fourteen (33%) were treated for non-HDN causes, including eight for septic neonates, two for neonates with necrotizing enterocolitis, two for neonates with a clinically significant antibody but without evidence of hemolysis, and two for neonates with glucose 6-phosphate dehydrogenase deficiency. A complete hemolytic workup was not performed consistently before the receipt of IVIG. This novel assessment of IVIG use in the NICU revealed the spectrum of disease for which IVIG is ordered. This study also found that key diagnostic tests needed to confirm an immune etiology for idiopathic jaundice are not performed routinely before IVIG receipt. Neonatal transfusion-related databases are needed to carry out pragmatic clinical trials to establish better evidence-based guidelines for IVIG therapy in the NICU.

A new predictive tool for the early risk assessment of gestational diabetes mellitus

AimsThe Italian National Institute of Health has recently introduced a selective screening based on the risk profile of pregnant women, which while recommending against screening of women at low risk (LR) for GDM, it recommends an early test for women at high risk (HR) for GDM. Herein, we assessed the accuracy and cost-effectiveness of this screening and developed a new index that improves these requirements. MethodsWe retrospectively enrolled 3974 pregnant women. GDM was diagnosed with a 2h 75-g OGTT at 16–18 weeks (early test) or 24–28 weeks of gestation, according to the IADPSG guidelines. Results55.6% of HR women had GDM, although only 38.4% underwent early screening. Among 2654 women at medium risk, 20.9% had GDM; paradoxically, among 770 LR women, that would not have been screened, 26.6% received a GDM diagnosis. Based on these unsatisfactory results, we elaborated the Capula's index, that reduced both screening tests (p<0.001) and potentially undetected GDM cases (p<0.001), and corrected the paradoxical prevalence estimates of GDM obtained with the current Italian guidelines. Also, Capula's index improved correlation of GDM risk profile with obstetric and neonatal adverse events. ConclusionsCapula's index improves accuracy of selective screening for GDM.

A meta-analysis of neonatal health outcomes from oocyte donation.

Donated oocytes are a treatment modality for female infertility which is also associated with increased risks of preeclampsia. Subsequently it is important to evaluate if there is concomitant increased risks for adverse neonatal events in donated oocyte neonates. A structured search of the literature using PubMed, EMBASE and Cochrane Reviews was performed to investigate the perinatal health outcomes of offspring conceived from donor oocytes compared with autologous oocytes. Meta-analysis was performed on comparable outcomes data. Twenty-eight studies were eligible and included in the review, and of these, 23 were included in a meta-analysis. Donor oocyte neonates are at increased risk of being born with low birth weight (&lt;2500 g) [risk ratio (RR): 1.18, 95% confidence interval (CI): 1.14-1.22, P-value (P)&lt;0.00001], very low birth weight (&lt;1500 g) (RR: 1.24, CI: 1.15-1.35, P&lt;0.00001), preterm (&lt;37 weeks) (RR: 1.26, CI: 1.23-1.30, P&lt;0.00001), of lower gestational age (mean difference -0.3 weeks, CI: -0.35 weeks to -0.25 weeks, P&lt;0.00001), and preterm with low birth weight (RR: 1.24, CI: 1.19-1.29, P&lt;0.00001), when compared with autologous oocyte neonates. Conversely, low birth weight outcomes were improved in term donor oocyte neonates (RR: 0.86, CI: 0.8-0.93, P=0.0003). These negative outcomes remained significant when controlling for multiple deliveries. The donor oocyte risk rates are higher than those found in general ART outcomes, are important considerations for the counselling of infertile patients and may also influence the long term health of the offspring.

Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia

BackgroundSystemic glucocorticoids reduce the incidence of bronchopulmonary dysplasia among extremely preterm infants, but they may compromise brain development. The effects of inhaled glucocorticoids on outcomes in these infants are unclear.MethodsWe randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to early (within 24 hours after birth) inhaled budesonide or placebo until they no longer required oxygen and positive-pressure support or until they reached a postmenstrual age of 32 weeks 0 days. The primary outcome was death or bronchopulmonary dysplasia, confirmed by means of standardized oxygen-saturation monitoring, at a postmenstrual age of 36 weeks.ResultsA total of 175 of 437 infants assigned to budesonide for whom adequate data were available (40.0%), as compared with 194 of 419 infants assigned to placebo for whom adequate data were available (46.3%), died or had bronchopulmonary dysplasia (relative risk, stratified according to gestational age, 0.86; 95% confidence interval [CI], 0.75 to 1.00; P=0.05). The incidence of bronchopulmonary dysplasia was 27.8% in the budesonide group versus 38.0% in the placebo group (relative risk, stratified according to gestational age, 0.74; 95% CI, 0.60 to 0.91; P=0.004); death occurred in 16.9% and 13.6% of the patients, respectively (relative risk, stratified according to gestational age, 1.24; 95% CI, 0.91 to 1.69; P=0.17). The proportion of infants who required surgical closure of a patent ductus arteriosus was lower in the budesonide group than in the placebo group (relative risk, stratified according to gestational age, 0.55; 95% CI, 0.36 to 0.83; P=0.004), as was the proportion of infants who required reintubation (relative risk, stratified according to gestational age, 0.58; 95% CI, 0.35 to 0.96; P=0.03). Rates of other neonatal illnesses and adverse events were similar in the two groups.ConclusionsAmong extremely preterm infants, the incidence of bronchopulmonary dysplasia was lower among those who received early inhaled budesonide than among those who received placebo, but the advantage may have been gained at the expense of increased mortality. (Funded by the European Union and Chiesi Farmaceutici; ClinicalTrials.gov number, NCT01035190.)

Can maternal DHA supplementation offer long-term protection against neonatal hyperoxic lung injury?

The effect of adverse perinatal environment (like maternal infection) has long-standing effects on many organ systems, including the respiratory system. Use of maternal nutritional supplements is an exciting therapeutic option that could be used to protect the developing fetus. In a recent issue of the journal, Ali and associates (Ali M, Heyob KM, Velten M, Tipple TE, Rogers LK. Am J Physiol Lung Cell Mol Physiol 309: L441-L448, 2015) specifically look at maternal docosahexaenoic acid (DHA) supplementation and its effect on chronic apoptosis in the lung in a mouse model of perinatal inflammation and postnatal hyperoxia. Strikingly, the authors show that pulmonary apoptosis was augmented even 8 wk after the hyperoxia-exposed mice had been returned to room air. This effect was significantly attenuated in mice that were subjected to maternal dietary DHA supplementation. These findings are novel, significantly advance our understanding of chronic effects of adverse perinatal and neonatal events on the developing lung, and thereby offer novel therapeutic options in the form of maternal dietary supplementation with DHA. This editorial reviews the long-term effects of adverse perinatal environment on postnatal lung development and the protective effects of dietary supplements such as DHA.

Magnetoencephalography: Neurophysiologic Imaging for Perinatal Brain Development

Magnetoencephalography (MEG) is a brain imaging modality with considerable promise for understanding early neonatal brain development and its alteration in clinical populations, together with the long-term consequences of premature birth and adverse neonatal events. This article discusses present and potential contributions of MEG to neonatology and neonatal follow-up. We give a brief overview of MEG and discuss its advantages and capabilities. We review fetal MEG and neonatal MEG, including the recent introduction of dedicated neonatal MEG systems. The use of MEG for understanding long-term neurocognitive outcome in populations such as school-aged children born very preterm will be discussed, as well as recent advances in MEG that represent significant opportunities for understanding neonatal brain development. In summary, MEG provides a powerful method to create a noninvasive record of neuronal activity throughout fetal development, neonatal life, and childhood.

Goal-directed fluid therapy may improve hemodynamic stability in parturient women under combined spinal epidural anesthesia for cesarean section and newborn well-being.

To investigate whether goal-directed fluid therapy (GDFT) with the LiDCOrapid system can reduce the incidence of maternal hypotension and improve neonatal outcome. One hundred healthy term parturient women scheduled for elective cesarean section were recruited. After loading with 10 mL/kg Lactated Ringer's solution, parturient women were randomized to the GDFT and control group. In the GDFT group, individualized fluid therapy was implemented to optimize stroke volume, guided by the LiDCOrapid system. The control group received routine fluid therapy. Primary endpoints included onset of maternal hypotension, and vasopressor doses prior to delivery. The secondary endpoints included umbilical blood gas abnormalities and neonatal adverse events. Incidence of hypotension and mean phenylephrine dose administered prior to delivery were significantly higher in the control group than in the GDFT group (P < 0.01). There was no difference in Apgar score between the two groups. In the control group, mean umbilical artery and vein blood pH were significantly lower, corresponding to significantly higher incidences of neonatal hypercapnia and hypoxemia, compared with the GDFT group (P < 0.05). LiDCOrapid -guided GDFT may provide benefit to healthy parturient women and their newborns.

Mechanical labor induction in the obese population: a secondary analysis of a prospective randomized trial.

The objective of this study was to estimate the influence of maternal body mass index (BMI) on progress and outcomes of labor induction using mechanical devices. This study was a secondary analysis of data collected during the Cook Catheter vs. Foley Catheter study, a series of prospective randomized trials of women requiring cervical ripening for labor induction. The duration, characteristics, and outcomes of labor were analyzed after stratification by BMI categories. Outcomes assessed included time from device insertion to delivery, successful ripening, cesarean delivery rates, and any maternal and neonatal adverse events. One hundred and eighty-one patients were stratified according to BMI categories, with 102 study participants classified as normal weight (BMI ≤30) and 79 as obese (BMI >30). Maternal satisfaction from the induction process was significantly lower in the obese group compared to the normal weight group (5.95 ± 3.14 vs. 7.58 ± 2.7, respectively, in a 1-10 scale, p = 0.009). The cesarean delivery rate was similar in the normal weight and the obese groups (17.6 vs. 25.3 %, respectively, p = 0.27). No statistical differences were found in all other outcomes evaluated, including a sub-analysis of the different mechanical devices. During the process of mechanical cervical ripening, maternal satisfaction, but not objective obstetrical parameters, was influenced by increased maternal BMI. The trial is registered at ClinicalTrials.gov, no: NCT00604487. Trial registry name is "Induction of Labor in Patients with Unfavorable Cervical Conditions."

The effectiveness of tranexamic acid at reducing postoperative blood loss following cesarean section: a systematic review of quantitative evidence protocol.

REVIEW QUESTION / OBJECTIVE The quantitative objective is to identify the effectiveness of tranexamic acid on reducing blood loss in women undergoing cesarean section up to twenty four hours postoperatively. INCLUSION CRITERIA Types of participants This review will consider studies that include women of any age undergoing cesarean section Types of intervention(s)/phenomena of interest This review will consider studies that evaluate administration of tranexamic Acid compared to administration of a placebo or no therapy. Types of outcomes This review will consider studies that include the following outcome measures: blood loss measured in milliliters within 24 hours postoperatively. Secondary outcomes of interest will include side effects of tranexamic acid, maternal adverse events, neonatal adverse events, and changes in hemoglobin or hematocrit.

The effectiveness of tranexamic acid at reducing postoperative blood loss following cesarean section: a systematic review of quantitative evidence protocol

The effectiveness of tranexamic acid at reducing postoperative blood loss following cesarean section: a systematic review of quantitative evidence protocol

Decreasing intrapartum malpractice: Targeting the most injurious neonatal adverse events.

Medical malpractice expenditures are mainly due to the occurrence of preventable harm with some of the highest liability rates in obstetrics. Establishing delivery system models which decrease preventable harm and malpractice risk have had varied results over the last decade. We conducted a case study of a risk reduction labor and delivery model at 5 demonstration sites. The model included standardized protocols for the most injurious events, training teams in labor and delivery emergencies, rapid reporting with cause analysis for all unplanned events, and disclosing unexpected occurrences to patients using coordinated communication and documentation. Each of the model's components required buy in from the hospital's clinical and administrative leadership, and it also required collaboration, training, and continual feedback to labor and delivery nurses, doctors, midwives, and risk managers. The case study examined the key elements in the development of the model based on interviews of all team members and document review. We also completed data analysis pre and post implementation of the new model to assess the impact on event reporting and high liability occurrence rates. After 27 months post implementation, reporting of unintended events increased significantly (43 vs 84 per 1000 births, p < .01) while high-risk malpractice events decreased significantly (14 vs 7 per 1000 births, p < .01). This decrease enabled money allotted for malpractice claims to be reallocated for the implementation of the new model at 42 additional labor and delivery sites. Due to these results, this multilevel integrated model showed promise.

Prenatal diagnosis and management of monoamniotic twins.

The purpose of this article is to investigate the perinatal outcomes of monoamniotic twins under current standards of prenatal management involving intensive fetal surveillance. The incidence of perinatal mortality in monoamniotic twins has fallen over the last 2 decades. Umbilical cord entanglement has long been considered one of the main causes of poor outcome among monoamniotic twins; however, new evidence shows that it appears to be less important than prematurity and congenital anomalies. If intensive fetal surveillance is provided, the risk of perinatal mortality is acceptably low regardless of setting. In uncomplicated monoamniotic twin pregnancies, delivery at around 33 weeks of gestation might reduce the risk of neonatal adverse events without increasing the risk of perinatal death. Perinatal outcome in monoamniotic twins improved if intensive fetal surveillance was performed under either outpatient or inpatient management. Planned delivery in uncomplicated monoamniotic twin pregnancies can be considered at around 33 weeks of gestation.

The safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review.

The present study provides a comprehensive review of the existing literature on the safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and lactation. Studies published in English, reporting the use of SNRIs in pregnant and/or breastfeeding women, were identified by searching MEDLINE/Pubmed, PsycINFO, and EMBASE. Twenty-nine studies were included in the review. Altogether, the initial evidence coming from the reviewed studies suggests a lack of association between SNRIs and an increased risk of major congenital malformations. Conversely, exposure to SNRIs seems to be significantly associated with an increased risk of some perinatal complications. No neonatal adverse events emerged, so far, in the few studies concerning the safety of SNRIs during breastfeeding. Available data suggest that venlafaxine is relatively safe during pregnancy, in particular as far as major malformations are concerned, whereas considering the small number of studies published, no definitive conclusions can be drawn on its safety during breastfeeding. Because of the few studies so far published, the safety of duloxetine during pregnancy and breastfeeding remains to be well established.

A risk calculator predicting postoperative adverse events in neonates undergoing major abdominal or thoracic surgery

PurposeThis study sought to demonstrate the feasibility of a risk calculator for neonates undergoing major abdominal or thoracic surgery with good discriminative ability. MethodsThe American College of Surgeons' National Surgical Quality Improvement Program Pediatric (ACS-NSQIP-P) 2011–12 data were queried for neonates who underwent major abdominal or thoracic surgery. The outcome of interest was the occurrence of any adverse event, including mortality, within 30-days postoperatively. The preoperative clinical characteristics significantly associated with any adverse event were used to build a multivariate model. The model's discriminative ability was assessed with the area under the receiver operating characteristic curve (AUROC). The model was split-set validated with 2013 data. ResultsA total of 2967 neonates undergoing major abdominal or thoracic surgery were identified. The overall rate of adverse events was 23.3%. Sixteen variables were found to be associated with adverse events. Four variables increased the odds of adverse events at least two-fold: dirty or infected wound class [odds ratio (OR)=2.1] dialysis (OR=3.8), hepatobiliary disease (OR=2.1), and inotropic agent use (OR=2.6). The AUROC=0.79 for development data and 0.77 on split-set validation. ConclusionPreoperatively estimating the probability of postoperative adverse events in neonates undergoing major abdominal or thoracic surgery with good discrimination is feasible.

Gestational diabetes mellitus screening and outcomes.

To verify the usefulness of the World Health Organization criteria for the diagnosis of gestational diabetes mellitus in pregnant women and its effectiveness in the prevention of maternal and neonatal adverse results in women younger than 35 years without apparent risk factors for gestational diabetes mellitus. This is a retrospective study based on population involving 1360 pregnant women who delivered and who were followed-up in a university hospital in Istanbul. All women underwent the 75-g oral glucose tolerance test screening, usually in between the 24(th)-28(th) weeks of pregnancy. In all cases, the identification of gestational diabetes mellitus was determined in accordance with the World Health Organization criteria. Approximately 28% of the pregnant women aged younger than 35 years with no risk factors for gestational diabetes mellitus were diagnosed with the oral glucose tolerance test in this study. In the gestational diabetes mellitus group, the primary cesarean section rate was importantly higher than that in the non-gestational diabetes mellitus group. Preterm delivery was also associated with gestational diabetes mellitus. The diagnosis of gestational diabetes mellitus was strongly associated with admittance to the neonatal intensive care unit. Neonatal respiratory problems didn't showed any significant deviation between the groups. There was a moderate association between gestational diabetes mellitus and metabolic complications. Pregnant women with no obvious risk factors were diagnosed with gestational diabetes mellitus using the World Health Organization criteria. The treatment of these women potentially reduced their risk of adverse maternal and neonatal hyperglycemia-related events, such as cesarean section, polyhydramnios, preterm delivery, admission to neonatal intensive care unit, large for gestational age, and higher neonatal weight.