Publications by authors named "Silvia Martini"

110 Publications

Probiotics for Preventing Necrotizing Enterocolitis in Preterm Infants: A Network Meta-Analysis.

Nutrients 2021 Jan 9;13(1). Epub 2021 Jan 9.

Neonatal Intensive Care Unit, AOU Bologna, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, 40138 Bologna, Italy.

Background: Recent evidence supports a role of probiotics in preventing necrotizing enterocolitis (NEC) in preterm infants.

Methods: A systematic review and network meta-analysis of randomized controlled trials (RCTs) on the role of probiotics in preventing NEC in preterm infants, focusing on the differential effect of type of feeding, was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A random-effects model was used; a subgroup analysis on exclusively human milk (HM)-fed infants vs. infants receiving formula (alone or with HM) was performed.

Results: Fifty-one trials were included (10,664 infants, 29 probiotic interventions); 31 studies (19 different probiotic regimens) were suitable for subgroup analysis according to feeding. In the overall analysis, LB revealed the most promising effect for reducing NEC risk (odds ratio (OR), 0.03; 95% credible intervals (CrIs), 0.00-0.21). The subgroup analysis showed that Bb-12/B94 was associated with a reduced risk of NEC stage ≥2 in both feeding type populations, with a discrepancy in the relative effect size in favour of exclusively HM-fed infants (OR 0.04; 95% CrIs <0.01-0.49 vs. OR 0.32; 95% CrIs 0.10-0.36).

Conclusions: Bb-12/B94 could reduce NEC risk with a different size effect according to feeding type. Of note, most probiotic strains are evaluated in few trials and relatively small populations, and outcome data according to feeding type are not available for all RCTs. Further trials are needed to confirm the present findings.
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http://dx.doi.org/10.3390/nu13010192DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7827781PMC
January 2021

Equivocal, explicit and emergent actions of PKC isoforms in cancer.

Nat Rev Cancer 2021 01 11;21(1):51-63. Epub 2020 Nov 11.

Protein Phosphorylation Laboratory, Francis Crick Institute, London, UK.

The maturing mutational landscape of cancer genomes, the development and application of clinical interventions and evolving insights into tumour-associated functions reveal unexpected features of the protein kinase C (PKC) family of serine/threonine protein kinases. These advances include recent work showing gain or loss-of-function mutations relating to driver or bystander roles, how conformational constraints and plasticity impact this class of proteins and how emergent cancer-associated properties may offer opportunities for intervention. The profound impact of the tumour microenvironment, reflected in the efficacy of immune checkpoint interventions, further prompts to incorporate PKC family actions and interventions in this ecosystem, informed by insights into the control of stromal and immune cell functions. Drugging PKC isoforms has offered much promise, but when and how is not obvious.
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http://dx.doi.org/10.1038/s41568-020-00310-4DOI Listing
January 2021

Can Plasma Rich in Growth Factors Expedite Healing of Postextraction Tooth Sockets in Patients Undergoing Urgent Liver Transplantation?

J Oral Maxillofac Surg 2021 02 24;79(2):305-312. Epub 2020 Sep 24.

Department Head, Department of Surgical Sciences of the Dental School of the University of Torino, Turin, Italy.

Purpose: Infections foster morbidity and mortality after liver transplantation (LT). Pre-LT eradication of oral infectious foci is not always possible for patients needing an urgent LT because postextraction sockets must be healed before the patient is operated, and this requires at least 3 weeks. To accelerate healing, we tested the effect of plasma-rich growth factor (PRGF), a highly concentrated form of autogenous platelets on healing.

Materials And Methods: Prospective case-control split-mouth study for more than 100 candidates for LT needing routine extractions of 2 homologous teeth: a socket was to be treated with PRGF, whereas its match (control [CTRL]) was to undergo natural healing. The outcome of interest was the socket size derived from the measurements on the transversal diameters and deepest level of penetration on the PRGF and CTRL sides after extraction and on day 7, 14, and 21 postextraction. The primary predictor was treatment status (PRGF vs CTRL); secondary predictors, the tooth extracted and patient's features. The statistical analysis used nonparametric tests and best subset regression.

Results: All measurements evidenced a significantly (P < .0001) more advanced closure on the PRGF side than the CTRL side. One week after extraction, PRGF sockets were reduced to 12% (molars) and 6% (nonmolars) of the original wound versus 32 and 20% for CTRL, respectively. The percentage of PRGF sockets with size less than or equal to 5% was 7% for molars and 44% for nonmolars versus 0 and 12% for CTRL (P < .0001), respectively. The percentages with size less than or equal to 10% were 37% for molars and 81% for nonmolars on the PRGF side versus 2 and 26% on the CTRL side, respectively. These percentages showed a significant decrease for smoking patients.

Conclusions: The outcome of our trial showed that PRGF significantly accelerates closure of postextraction sockets. Its use, at least in patients who occupy top positions in the LT waiting list, is recommended.
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http://dx.doi.org/10.1016/j.joms.2020.09.033DOI Listing
February 2021

A cancer-associated, genome protective programme engaging PKCε.

Adv Biol Regul 2020 12 7;78:100759. Epub 2020 Oct 7.

Protein Phosphorylation Laboratory, Francis Crick Institute, London, NW1 1AT, UK.

Associated with their roles as targets for tumour promoters, there has been a long-standing interest in how members of the protein kinase C (PKC) family act to modulate cell growth and division. This has generated a great deal of observational data, but has for the most part not afforded clear mechanistic insights into the control mechanisms at play. Here, we review the roles of PKCε in protecting transformed cells from non-disjunction. In this particular cell cycle context, there is a growing understanding of the pathways involved, affording biomarker and interventional insights and opportunities.
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http://dx.doi.org/10.1016/j.jbior.2020.100759DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689578PMC
December 2020

Selinexor Sensitizes TRAIL-R2-Positive TNBC Cells to the Activity of TRAIL-R2xCD3 Bispecific Antibody.

Cells 2020 10 2;9(10). Epub 2020 Oct 2.

Biomarkers Unit, Department of Applied Research and Technical Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy.

Triple-negative breast cancer (TNBC) is an aggressive disease with poor prognosis and limited therapeutic options. Recent advances in the immunotherapy field have enabled the development of new treatment strategies, among which the use of bispecific antibodies (BsAbs), able to redirect T cells against tumors, has shown promising results. In particular, a BsAb that uses TNF-related apoptosis-inducing ligand receptor 2 (TRAIL-R2) as a target was constructed and demonstrated good results in redirecting CD3 T cells to kill TRAIL-R2-expressing TNBC cells. In the present study, we investigated whether treatment with selinexor, a selective inhibitor of nuclear export (SINE) targeting exportin-1/chromosome maintenance protein 1 (XPO1/CRM1), could potentiate the antitumor activity of this BsAb. In combination experiments, we found that selinexor-exposed TNBC cells exhibited greater growth inhibition when treated with the TRAIL-R2xCD3 BsAb than that expected by simple additivity. Similarly, the apoptosis rate in selinexor/TRAIL-R2xCD3 BsAb-treated TNBC cells was significantly higher than that observed after exposure to either single agent. Together, our results suggest that the combination of selinexor and TRAIL-R2xCD3 BsAb can be a viable anticancer strategy and indicate this treatment as a promising therapeutic option for TNBC patients.
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http://dx.doi.org/10.3390/cells9102231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7599683PMC
October 2020

Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section.

Eur J Pediatr 2021 Mar 19;180(3):869-876. Epub 2020 Sep 19.

Neonatal Intensive Care Unit, AOU Bologna, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

We aimed to evaluate the reliability of lung ultrasound (LU) to predict admission to the neonatal intensive care unit (NICU) for transient neonatal tachypnoea or respiratory distress syndrome in infants born by caesarean section (CS). A prospective, observational, single-centre study was performed in the delivery room and NICU of Sant'Orsola-Malpighi Hospital in Bologna, Italy. Term and late-preterm infants born by CS were included. LU was performed at 30' and 4 h after birth. LU appearance was graded according to a previously validated three-point scoring system (3P-LUS: type-1, white lung; type-2, black/white lung; type-3, normal lung). Full LUS was also calculated. One hundred infants were enrolled, and seven were admitted to the NICU. The 5 infants with bilateral type-1 lung at birth were all admitted to the NICU. Infants with type-2 and/or type-3 lung were unlikely to be admitted to the NICU. Mean full-LUS was 17 in infants admitted to the NICU, and 8 in infants not admitted. In two separate binary logistic regression models, both the 3P- and the full LUS proved to be independently associated with NICU admission (OR [95% CI] 0.001 [0.000-0.058], P = .001, and 2.890 [1.472-5.672], P = .002, respectively). The ROC analysis for the 3P-LUS yielded an AUC of 0.942 (95%CI, 0.876-0.979; P<.001), while ROC analysis for the full LUS yielded an AUC of 0.978 (95%CI, 0.926-0.997; P<.001). The AUCs for the two LU scores were not significantly different (p = .261).Conclusion: the 3P-LUS performed 30 min after birth proved to be a reliable tool to identify, among term and late preterm infants born to CS, those who will require NICU admission for transient neonatal tachypnoea or respiratory distress syndrome. What is known • Lung ultrasound (LU) has become an attractive diagnostic tool in neonatal settings, and guidelines on point-of-care LU in the neonatal intensive care unit (NICU) have been recently issued. • LU is currently used for diagnosing several neonatal respiratory morbidities and has been also proposed for predicting further intervention, such as NICU admission, need for surfactant treatment or mechanical ventilation in preterm infants. What is new • LU performed 30' after birth and evaluated through a simple three-point scoring system represents a reliable tool to identify, among term and late preterm infants born to caesarean section, those with transient neonatal tachypnoea or respiratory distress syndrome who will require NICU admission. • LU performed in the neonatal period confirms its potential role in ameliorating routine neonatal clinical management.
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http://dx.doi.org/10.1007/s00431-020-03789-zDOI Listing
March 2021

Teaching NeuroImages: Neurovascular features of suspected antenatal-onset Sturge-Weber syndrome without skin involvement.

Neurology 2020 12 4;95(22):e3070-e3071. Epub 2020 Sep 4.

From the Neonatal Intensive Care Unit (S.M., V.P., L.C.), S. Orsola-Malpighi University Hospital; Department of Medical and Surgical Sciences (DIMEC) (S.M., L.C., D.M.C.), University of Bologna; IRCCS Istituto delle Scienze Neurologiche di Bologna (F.T.), UOC Neuroradiologia; and Child Neurology and Psychiatry Unit (D.M.C.), S. Orsola-Malpighi University Hospital, Bologna, Italy.

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http://dx.doi.org/10.1212/WNL.0000000000010759DOI Listing
December 2020

Carrying on with liver transplantation during the COVID-19 emergency: Report from piedmont region.

Clin Res Hepatol Gastroenterol 2020 Aug 7:101512. Epub 2020 Aug 7.

General Surgery 2U, Liver Transplantation Center, AOU Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy.

Background: The COVID-19 pandemic is an emergency worldwide. In Italy, liver transplant activity was carried on, but despite all efforts, a 25% reduction of procured organs has already been observed during the first 4 weeks of the outbreak.

Aims: To analyze if our strategy and organization of LT pathway during the first two months of the COVID-19 emergency succeeded in keeping a high level of LT activity, comparing the number of LT in the first two months with the same period of time in 2019.

Methods: We compared the liver transplants performed in our Center between February 24th and April 17th, 2020 with liver transplants performed in the same period in 2019.

Results: In 2020, 21 patients underwent liver transplantation from deceased donors, exactly as the year before, without statistically significant difference. All patients survived in both groups, and the rate of early graft dysfunction was 24% in 2020 and 33% in 2019. In 2020 Median MELD was higher (17 vs 13). We were able to perform 3 multiorgan transplants and one acute liver failure. Nobody died on waiting list. The performance of our Center, despite the maxi-emergency situation, was steady and this was the result of a tremendous team working within the hospital and in our region.

Conclusions: Team working allowed our Center to maintain its activity level, taking care of patients before and after liver transplantation. Sharing our experience, we hope to be helpful to other Centers that are facing the pandemic and, if another pandemic comes, to be more prepared to deal with it.
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http://dx.doi.org/10.1016/j.clinre.2020.07.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413117PMC
August 2020

Urgent liver transplantation soon after recovery from COVID-19 in a patient with decompensated liver cirrhosis.

Hepatol Commun 2020 Jul 14. Epub 2020 Jul 14.

General Surgery 2U - Liver Transplant Unit AOU Città della Salute e della Scienza di Torino University of Turin Turin Italy.

Italy has been the first Western nation facing COVID-19 outbreak. Despite the emergency situation, all efforts have been done to preserve liver transplant (LT) activity and to minimize the impact of current scenario on transplant waiting list time and mortality. Little is known about COVID-19 consequences in transplant candidates, especially those with limited life expectancy due to the severity of their baseline disease. We report here the case of a young patient requiring inpatient care due to severe decompensated liver disease (MELD 24), justifying her referral from her local hospital to our high-volume LT unit, despite the unfavourable COVID-19 epidemiology in our Region. She was quickly listed for liver transplant (MELD 26), but 5 days later she was incidentally diagnosed with COVID-19 in the setting of our surveillance program for very sick patients and, despite her underlying condition, had an indolent course of the viral disease. Concerns about potential COVID-19 consequences in a LT candidate were overruled by the severity of liver disease (MELD 36), forcing our team to proceed with an urgent successful LT as soon as 9 days after the COVID-19 diagnosis, 2 days after the first negative SARS-CoV-2 RNA by a nasopharyngeal swab and 1 day after the confirmation of its negativity on bronchoalveolar lavage. The patient was discharged on day 9 after LT. In conclusion, to the best of our knowledge, this is the first report of a LT candidate recovering from a mild form of COVID19 and undergoing a successful LT shortly after. Aggressive care should be maintained in SARS-CoV-2-positive patients with decompensated cirrhosis in order to overcome viral infection and to proceed as soon as possible with life-saving treatment.
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http://dx.doi.org/10.1002/hep4.1580DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404870PMC
July 2020

Cerebral Oxygenation and Autoregulation in Very Preterm Infants Developing IVH During the Transitional Period: A Pilot Study.

Front Pediatr 2020 15;8:381. Epub 2020 Jul 15.

Neonatal Intensive Care Unit, S. Orsola-Malpighi University Hospital, Bologna, Italy.

The transitional period, defined as the first 72 h after preterm birth, is often characterized by a significant hemodynamic instability, which represents an important risk factor for such neurological complications of prematurity as intraventricular hemorrhage (IVH). The impairment of cerebral autoregulation plays a key role in the pathogenesis of IVH, whose incidence is highest during the transitional period. This pilot study aimed to evaluate whether patterns of cerebral autoregulation and oxygenation differ in relation to IVH development in very preterm infants during the transitional period. Infants <32 weeks' gestation were enrolled within 12 h from birth. A simultaneous monitoring of cerebral oxygenation (CrSO) by near-infrared spectroscopy and of heart rate and peripheral oxygen saturation by pulse oximetry was performed over the first 72 h. Cerebral fractional oxygen extraction (cFTOE) and tissue oxygenation-heart rate reactivity index (TOHRx), which represents a marker of cerebrovascular reactivity, were calculated. Daily cranial and cardiac ultrasound scans were performed, in order to assess the hemodynamic status and to detect a possible IVH onset. CrSO and cFTOE, clustered on 6-hour epochs, were compared between infants who developed IVH during the study period and those who did not. A between-group comparison of TOHRx before and after IVH detection was also performed. Twenty preterm infants with a median gestational age of 27 weeks (interquartile range, IQR: 25-30 weeks) and median birth weight of 895 g (IQR: 822-1208 g) were enrolled. Of these, 8 developed IVH. The median age at IVH detection was 40 h (IQR: 30-48 h). Pre-IVH TOHRx was significantly higher compared to matched control periods ( <0.001). CrSO was significantly lower from 12 to 30 h and from 42 h onwards in cases compared to controls; however, a temporary CrSO rise preceded IVH detection. Similarly, cFTOE was significantly higher in IVH infants from 12 to 30 h and from 48 to 72 h, with a transient decrease between the two periods. In preterm infants during the transitional period, the development of IVH is preceded by transient changes in cerebral oxygenation and oxygen extraction which, in turn, may underlie an early impairment of cerebral autoregulation. Larger studies are needed to confirm these preliminary findings.
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http://dx.doi.org/10.3389/fped.2020.00381DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373744PMC
July 2020

Seroprevalence of Hepatitis E Virus in liver transplant patients in Turin, Italy.

Panminerva Med 2020 Jul 22. Epub 2020 Jul 22.

Microbiology and Virology Unit, University Hospital Città della Salute e della Scienza di Torino, Turin, Italy -

Background: Acute E hepatitis is usually a self-limited non-progressive disease; however, acute liver failure and death can occur in the presence of particular conditions such as pregnancy and chronic liver diseases. In immunocompromised individuals, such as transplant patients, acute hepatitis E virus (HEV) infection may evolve to chronic hepatitis with rapid progression to liver decompensation. At our center, serology for HEV is not routinely performed in transplant patients and serological status is investigated only on the basis of clinical judgement.

Methods: In this study, seroprevalence of HEV was evaluated in 217 patients (120 liver transplant recipients and 97 individuals diagnosed with acute or chronic hepatitis). Molecular evaluation of HEV-RNA was also performed.

Results: Thirteen patients (6%) showed positivity for HEV-IgG; in particular, 10/120 (8.3%), with concomitant presence of IgM and IgG in six and 3/97 (3.1%). None of the plasma samples tested by HEV-RNA was positive.

Conclusions: As the detectable RNA window is narrow and an undetectable HEVRNA result does not exclude recent infection and the transplant context per se represents a risk factor for chronic infection in patients infected with HEV, a routine diagnostic workflow including HEV should be taken into consideration, increasing awareness and knowledge of the basic and clinical aspects of the disease.
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http://dx.doi.org/10.23736/S0031-0808.20.03877-XDOI Listing
July 2020

Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial.

Lancet Oncol 2020 07;21(7):947-956

Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.

Background: Indications for liver transplantation for hepatocellular carcinoma are evolving and so-called expanded criteria remain debated. Locoregional therapies are able to downstage hepatocellular carcinoma from beyond to within the Milan criteria. We aimed to investigate the efficacy of liver transplantation after successful hepatocellular carcinoma downstaging.

Methods: We did an open-label, multicentre, randomised, controlled trial designed in two phases, 2b and 3, at nine Italian tertiary care and transplantation centres. Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision. After an observation period of 3 months, during which sorafenib was allowed, patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors were randomly assigned (1:1) by an interactive web-response system to liver transplantation or non-transplantation therapies (control group). A block randomisation (block size of 2), stratified by centre and compliance to sorafenib treatment, was applied. Liver transplantation was done with whole or split organs procured from brain-dead donors. The control group received sequences of locoregional and systemic treatment at the time of demonstrated tumour progression. The primary outcomes were 5-year tumour event-free survival for phase 2b and overall survival for phase 3. Analyses were by intention to treat. Organ allocation policy changed during the course of the study and restricted patient accrual to 4 years. This trial is registered with ClinicalTrials.gov, NCT01387503.

Findings: Between March 1, 2011, and March 31, 2015, 74 patients were enrolled. Median duration of downstaging was 6 months (IQR 4-11). 29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group. At data cutoff on July 31, 2019, median follow-up was 71 months (IQR 60-85). 5-year tumour event-free survival was 76·8% (95% CI 60·8-96·9) in the transplantation group versus 18·3% (7·1-47·0) in the control group (hazard ratio [HR] 0·20, 95% CI 0·07-0·57; p=0·003). 5-year overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035). The most common registered grade 3-4 serious adverse events were hepatitis C virus recurrence (three [13%] of 23 patients) and acute transplant rejection (two [9%]) in the transplantation group, and post-embolisation syndrome (two [9%] of 22 patients) in the control group. Treatment-related deaths occurred in four patients: two (8%) of 23 patients in the transplantation group (myocardial infarction and multi-organ failure) versus two (9%) of 22 patients in the control group (liver decompensation).

Interpretation: Although results must be interpreted with caution owing to the early closing of the trial, after effective and sustained downstaging of eligible hepatocellular carcinomas beyond the Milan criteria, liver transplantation improved tumour event-free survival and overall survival compared with non-transplantation therapies Post-downstaging tumour response could contribute to the expansion of hepatocellular carcinoma transplantation criteria.

Funding: Italian Ministry of Health.
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http://dx.doi.org/10.1016/S1470-2045(20)30224-2DOI Listing
July 2020

Cardiovascular and cerebrovascular responses to cardio-respiratory events in preterm infants during the transitional period.

J Physiol 2020 09 23;598(18):4107-4119. Epub 2020 Jul 23.

Neonatal Intensive Care Unit, The Rosie Hospital, Cambridge University Hospitals, Cambridge, UK.

Key Points: Non-invasive simultaneous multiparametric monitoring allows the in vivo evaluation of cerebral and cardiovascular haemodynamic responses to different types of recurrent episodes of intermittent hypoxia and/or bradycardia, also defined as cardio-respiratory events (CRE), in preterm neonates during postnatal transition. By decreasing left cardiac output, bradycardia further contributes to cerebral hypoxia during CRE. The presence of a haemodynamically significant patent ductus arteriosus results in a deeper impairment of cerebral oxygen status in response to CRE, whereas the brain-sparing remodelling of the fetal circulation resulting from placental insufficiency is associated with more favourable haemodynamic responses to intermittent hypoxia. During transition, the haemodynamic impact of CRE is influenced not only by the event type, but also by specific clinical features; this highlights the importance of developing individualized approaches to reduce the hypoxic burden in this delicate phase.

Abstract: The present observational prospective study aimed to investigate cerebral and cardiovascular haemodynamic responses to different types of cardio-respiratory events (CRE) in preterm infants during postnatal transition, as well as evaluate the impact of relevant clinical characteristics. Infants with gestational age (GA) <32 weeks and/or birth weight <1500 g were enrolled after birth. Cerebral oxygenation index (cTOI), fractional oxygen extraction (cFTOE), cardiac output (CO), cardiac contractility (iCON) and systemic vascular resistances (sVR) were simultaneously monitored over the first 72 h by near-infrared spectroscopy and electrical velocimetry. CRE were clustered into isolated bradycardia (IB), isolated desaturation (ID) and combined desaturation/bradycardia (DB). For each parameter, percentage changes from baseline (%Δ) were calculated. The impact of different CRE types and clinical variables on %Δ was evaluated with generalized estimating equations. In total, 1426 events were analysed. %ΔcTOI significantly differed among ID, IB and DB (P < 0.001), with the latter showing the greatest drop. %ΔcFTOE decreased significantly during DB (P < 0.001) and ID (P < 0.001) compared to IB. DB and IB were associated with more negative %ΔCO (P < 0.001) and more positive %ΔsVR (P < 0.001) compared to ID. A slight iCON reduction was observed during DB compared to ID (P = 0.043). Antenatal umbilical Doppler impairment, GA and the presence of a haemodynamically significant patent ductus arteriosus had a significant independent impact on %ΔcTOI, %ΔcFTOE and %ΔCO. During the transitional period, the haemodynamic responses to CRE are influenced by the event type and by specific neonatal characteristics, suggesting the importance of targeted individualized approaches for minimizing the risk of cerebral injury in the preterm population.
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http://dx.doi.org/10.1113/JP279730DOI Listing
September 2020

Author Correction: The Aurora B specificity switch is required to protect from non-disjunction at the metaphase/anaphase transition.

Nat Commun 2020 06 3;11(1):2884. Epub 2020 Jun 3.

Protein Phosphorylation Laboratory, Francis Crick Institute, 1 Midland Rd, London, NW1 1AT, UK.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41467-020-16468-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7271126PMC
June 2020

Cardiorespiratory Events in Infants Born Preterm during the Transitional Period.

J Pediatr 2020 06;221:32-38.e2

Neonatal Intensive Care Unit, St Orsola-Malpighi University Hospital, Bologna, Italy; Department of Medical and Surgical Sciences (DIMEC).

Objective: To investigate the features of cardiorespiratory events in infants born preterm during the transitional period, and to evaluate whether different neonatal characteristics may correlate with event type, duration, and severity.

Study Design: Infants with gestational age (GA) <32 weeks and/or birth weight <1500 g were enrolled in this observational prospective study. Heart rate (HR) and peripheral oxygen saturation (SpO) were recorded continuously over the first 72 hours. Cardiorespiratory events of ≥10 seconds were clustered into isolated desaturation (SpO <85%), isolated bradycardia (HR <100 bpm or <70% of baseline), or combined desaturation/bradycardia and classified as mild, moderate, or severe. The daily incidences of isolated desaturation, isolated bradycardia, and combined desaturation and bradycardia were analyzed. The effects of relevant clinical variables on cardiorespiratory event type and severity were assessed using generalized estimating equations.

Results: Among the 1050 events analyzed, isolated desaturations were the most frequent (n = 625) and isolated bradycardias the least common (n = 171). The number of cardiorespiratory events increased significantly from day 1 to day 2 (P = .028). One in 5 events had severe characteristics; event severity was highest for combined desaturation and bradycardia (P < .001). Compared with other event types, the incidence of combined desaturation and bradycardia was inversely correlated with GA (P = .029) and was higher with the use of continuous positive airway pressure (P = .002). The presence of a hemodynamically significant patent ductus arteriosus was associated with the occurrence of isolated desaturations (P = .001) and with a longer duration of cardiorespiratory events (P = .003).

Conclusions: Cardiorespiratory events during transition exhibit distinct types, duration, and severity. Neonatal characteristics are associated with the clinical features of these events, indicating that a tailored clinical approach may reduce the hypoxic burden in preterm infants aged 0-72 hours.
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http://dx.doi.org/10.1016/j.jpeds.2020.02.037DOI Listing
June 2020

Targeting Orthosteric and Allosteric Pockets of Aromatase via Dual-Mode Novel Azole Inhibitors.

ACS Med Chem Lett 2020 May 23;11(5):732-739. Epub 2020 Mar 23.

CNR-IOM Democritos c/o International School for Advanced Studies (SISSA), Via Bonomea 265, 34136 Trieste, Italy.

Breast cancer (BC) is the most diffused cancer type in women and the second leading cause of death among the female population. Effective strategies to fight estrogen responsive (ER+) BC, which represents 70% of all BC cases, rely on estrogen deprivation, via the inhibition of the aromatase enzyme, or the modulation of its cognate estrogen receptor. Current clinical therapies significantly increased patient survival time. Nevertheless, the onset of resistance in metastatic BC patients undergoing prolonged treatments is becoming a current clinical challenge, urgently demanding to devise innovative strategies. In this context, here we designed, synthesized, and performed in vitro inhibitory tests on the aromatase enzyme and distinct ER+/ER- BC cell line types of novel azole bridged xanthones. These compounds are active in the low μM range and behave as dual-mode inhibitors, targeting both the orthosteric and the allosteric sites of the enzyme placed along one access channel. Classical and quantum-classical molecular dynamics simulations of the new compounds, as compared with selected steroidal and nonsteroidal inhibitors, provide a rationale to the observed inhibitory potency and supply the guidelines to boost the activity of inhibitors able to exploit coordination to iron and occupation of the access channel to modulate estrogen production.
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http://dx.doi.org/10.1021/acsmedchemlett.9b00591DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236249PMC
May 2020

Red blood cell transfusions alter splanchnic oxygenation response to enteral feeding in preterm infants: an observational pilot study.

Transfusion 2020 Aug 1;60(8):1669-1675. Epub 2020 May 1.

Neonatal Intensive Care Unit, S. Orsola-Malpighi University Hospital, Bologna, Italy.

Background: Preterm infants often require red blood cell (RBC) transfusions, which may impair splanchnic hemodynamics, thus predisposing to necrotizing enterocolitis (NEC). The aim of this study was to evaluate whether RBC transfusions alter splanchnic oxygenation patterns in response to enteral feeding in this population.

Materials And Methods: Preterm neonates (gestational age < 32 weeks and/or birth weight < 1500 g) requiring RBC transfusions for anemia underwent a 12-hour Near Infrared Spectroscopy monitoring of splanchnic (SrSO ) and cerebral (CrSO ) oxygenation, including the transfusion period, one feed before and one after. Splanchnic-cerebral oxygenation ratio (SCOR) was also calculated. Patterns of CrSO , SrSO , and SCOR changes from baseline (Δ) in response to feed before and after transfusion were analyzed.

Results: Twenty neonates were enrolled; none of them developed any gastrointestinal complication within 48 hours after transfusion. Pre-transfusion ΔSrSO and ΔSCOR increased significantly in response to feeding; on the contrary, a significant post-prandial decrease of ΔSrSO and ΔSCOR occurred after transfusion (p < 0.05). No difference in pre- and post-transfusion ΔCrSO patterns was observed.

Conclusions: In preterm infants, RBC transfusions may alter splanchnic oxygenation response to enteral feeds. Whether these changes are involved in the pathogenesis of transfusion-associated NEC has to be evaluated in further larger trials.
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http://dx.doi.org/10.1111/trf.15821DOI Listing
August 2020

Biomarkers of Kidney Injury in Very-low-birth-weight Preterm Infants: Influence of Maternal and Neonatal Factors.

In Vivo 2020 May-Jun;34(3):1333-1339

Department of Experimental Diagnostic and Specialty Medicine (DIMES), Nephrology, Dialysis and Renal Transplant Unit, St. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy

Background/aim: Acute kidney injury is an important cause of mortality in very-low-birth-weight (VLBW) preterm infants. As in the general population, the detection of renal damage cannot rely on the measurement of serum creatinine, since it has been demonstrated to be a weak predictor and a delayed indicator of kidney function deterioration. However, several candidate biomarkers have failed to prove sufficient specificity and sensitivity for a routine clinical use because of the poor awareness of their biological role. This study was aimed to investigate the impact of different maternal and neonatal conditions on several renal biomarkers in VLBW preterm infants during the first week of life.

Patients And Methods: Preterm infants<32 weeks' gestation and <1500g were enrolled. We measured urinary biomarkers kidney injury molecule 1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, epidermal growth factor (EGF) and osteopontin (OPN) on the 1, 3, and 7 day after birth.

Results: Thirty-tree infants were included. The multivariate analysis showed a significant association between gestational age, the presence of patent ductus arteriosus, antenatal maternal hypertension and the levels of urinary biomarkers.

Conclusion: There is a possible relation between early biomarkers of renal injury and antenatal, perinatal and post-natal characteristics in VLBW preterm infants during the first week of life.
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http://dx.doi.org/10.21873/invivo.11910DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7279835PMC
February 2021

GMMA and Glycoconjugate Approaches Compared in Mice for the Development of a Vaccine against Serotype 6.

Vaccines (Basel) 2020 Apr 3;8(2). Epub 2020 Apr 3.

GSK Vaccines Institute for Global Health (GVGH) S.r.l., via Fiorentina 1, 53100 Siena, Italy.

infections are one of the top causes of diarrhea throughout the world, with being predominant in developing countries. Currently, no vaccines are widely available and increasing levels of multidrug-resistance make a high priority for vaccine development. The serotype-specific O-antigen moiety of lipopolysaccharide has been recognized as a key target for protective immunity, and many O-antigen based candidate vaccines are in development. Recently, the Generalized Modules for Membrane Antigens (GMMA) technology has been proposed as an alternative approach to traditional glycoconjugate vaccines for O-antigen delivery. Here, these two technologies are compared for a vaccine against serotype 6. Genetic strategies for GMMA production, conjugation approaches for linkage of the O-antigen to CRM carrier protein, and a large panel of analytical methods for full vaccine characterization have been put in place. In a head-to-head immunogenicity study in mice, GMMA induced higher anti-O-antigen IgG than glycoconjugate administered without Alhydrogel. When formulated on Alhydrogel, GMMA and glycoconjugate elicited similar levels of persistent anti-O-antigen IgG with bactericidal activity. Glycoconjugates are a well-established bacterial vaccine approach, but can be costly, particularly when multicomponent preparations are required. With similar immunogenicity and a simpler manufacturing process, GMMA are a promising strategy for the development of a vaccine against .
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http://dx.doi.org/10.3390/vaccines8020160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7349896PMC
April 2020

The Aurora B specificity switch is required to protect from non-disjunction at the metaphase/anaphase transition.

Nat Commun 2020 03 13;11(1):1396. Epub 2020 Mar 13.

Protein Phosphorylation Laboratory, Francis Crick Institute, 1 Midland Rd, London, NW1 1AT, UK.

The Aurora B abscission checkpoint delays cytokinesis until resolution of DNA trapped in the cleavage furrow. This process involves PKCε phosphorylation of Aurora B S227. Assessing if this PKCε-Aurora B module provides a more widely exploited genome-protective control for the cell cycle, we show Aurora B phosphorylation at S227 by PKCε also occurs during mitosis. Expression of Aurora B S227A phenocopies inhibition of PKCε in by-passing the delay and resolution at anaphase entry that is associated with non-disjunction and catenation of sister chromatids. Implementation of this anaphase delay is reflected in PKCε activation following cell cycle dependent cleavage by caspase 7; knock-down of caspase 7 phenocopies PKCε loss, in a manner rescued by ectopically expressing/generating a free PKCε catalytic domain. Molecular dynamics indicates that Aurora B S227 phosphorylation induces conformational changes and this manifests in a profound switch in specificity towards S29 TopoIIα phosphorylation, a response necessary for catenation resolution during mitosis.
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http://dx.doi.org/10.1038/s41467-020-15163-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7070073PMC
March 2020

Outcomes of Liver Transplant for Adults With Wilson's Disease.

Liver Transpl 2020 04 23;26(4):507-516. Epub 2020 Feb 23.

Multivisceral Transplant Unit, Department of Surgery, Oncology, and Gastroenterology, Padua University Hospital, Padua, Italy.

Wilson's disease (WD) is a rare genetic disorder with protean manifestations. Even if liver transplantation (LT) could represent an effective therapeutic option for patients with end-stage liver disease, it has remained controversial in the presence of neuropsychiatric involvement. This study aimed to examine the frequency of adult LT for WD in Italy, focusing on the disease phenotype at the time of LT. A retrospective, observational, multicenter study was conducted across Italy exploring the frequency and characteristics of adults transplanted for WD between 2006 and 2016. A total of 29 adult WD patients underwent LT during the study period at 11 Italian LT centers (accounting for 0.4% of all LTs performed), and 27 of them were considered in this analysis (male/female, n = 9/18; age at LT, 29 years [19-60 years]; median Model for End-Stage Liver Disease score at LT, 27 [6-49]). Isolated hepatic phenotype was the indication for LT in 17 (63%) patients, whereas 2 (7%) patients underwent LT for neurological impairment on compensated liver disease. Overall 1- and 5-year patient survival was excellent (88% and 83%, respectively). Neuropsychiatric symptoms early after LT completely recovered in only a few patients. In conclusion, WD remains an uncommon, unusual indication for LT in Italy, displaying good post-LT graft and patient survival. Because isolated neuropsychiatric involvement represents a rare indication to LT, more data are needed to properly assess the value of LT for WD in this subset of patients.
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http://dx.doi.org/10.1002/lt.25714DOI Listing
April 2020

To Feed or Not to Feed: A Critical Overview of Enteral Feeding Management and Gastrointestinal Complications in Preterm Neonates with a Patent Ductus Arteriosus.

Nutrients 2019 Dec 27;12(1). Epub 2019 Dec 27.

Neonatal Intensive Care Unit, S. Orsola-Malpighi University Hospital, Department of Medical and Surgical Sciences, University of Bologna, 40138 Bologna, Italy.

The management of enteral feeds in preterm infants with a hemodynamically significant patent ductus arteriosus (hs-PDA) is a major challenge for neonatologists due to the fear of gastrointestinal (GI) complications. This review aims to analyze the available evidence on the complex relation between the presence and management of PDA, enteral feeding practices, and GI outcomes in the preterm population. There is limited evidence, based on small and heterogeneous trials, that hs-PDA may affect the splanchnic hemodynamic response to enteral feeds. While the presence of PDA seems a risk factor for adverse GI outcomes, the benefits of feeding withholding during pharmacological PDA treatment are controversial. The lack of robust evidence in support of or against a timely feeding introduction or feeding withholding during pharmacological PDA closure in preterm neonates does not allow to draw any related recommendation. While waiting for further data, the feeding management of this population should be carefully evaluated and possibly individualized on the basis of the infants' hemodynamic and clinical characteristics. Large, multicentric trials would help to better clarify the physiological mechanisms underlying the development of gut hypoperfusion, and to evaluate the impact of enteral feeds on splanchnic hemodynamics in relation to PDA features and treatment.
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http://dx.doi.org/10.3390/nu12010083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019993PMC
December 2019

Effect of Alternative Pasteurization Techniques on Human Milk's Bioactive Proteins.

J Pediatr Gastroenterol Nutr 2020 04;70(4):508-512

Department of Medical and Surgical Sciences, Neonatal Intensive Care Unit, AOU Bologna, University of Bologna, Bologna.

Objectives: Human milk (HM) feeding leads to improved outcome for preterm infants. When mother's milk is unavailable, pasteurized donor HM (DHM) is the recommended alternative over formula. The Holder pasteurization (HoP) method is universally performed in HM banks; however, it is known to impair several functional HM components. The aim of this study was to compare the efficacy of HoP with 2 innovative processing methods (high-temperature short-time [HTST] pasteurization and high-pressure processing [HPP]) in preserving some bioactive HM protein components.

Methods: HM samples from donors of the Bologna HM bank were collected and divided into 4 subsamples: 1 was kept raw, and each of the others was processed using a different technique (HoP, HTST, and HPP at 600 MPa for 3 minutes). Total protein content, secretory immunoglobulin A (sIgA), and lactoferrin contents were compared.

Results: Both HM lactoferrin and sIgA content were negatively affected, but to a different extent, by each method: sIgA was preserved by HTST, with only HPP leading to a significant reduction (-38.8%); lactoferrin content was strongly reduced by HoP (-87.5%) and HTST (-83.5%), and preserved by HPP. Variations in protein profile were seen for all processing methods, being more relevant for HoP, followed by HTST and, finally, by HPP. All the 3 methods lowered the untreated HM microbial counts to undetectable levels, in accordance with national guidelines.

Conclusions: Both HTST and HPP better preserved the original HM protein profile, compared to HoP. They, however, affected differently some bioactive HM components involved in immune response and antibacterial activity.
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http://dx.doi.org/10.1097/MPG.0000000000002598DOI Listing
April 2020

Human Milk's Hidden Gift: Implications of the Milk Microbiome for Preterm Infants' Health.

Nutrients 2019 Dec 4;11(12). Epub 2019 Dec 4.

Neonatal Intensive Care Unit, AOU Bologna, Department of Medical and Surgical Sciences (DIMEC), University of Bologna. via Massarenti, 11-40138 Bologna, Italy.

Breastfeeding is considered the gold standard for infants' nutrition, as mother's own milk (MOM) provides nutritional and bioactive factors functional to optimal development. Early life microbiome is one of the main contributors to short and long-term infant health status, with the gut microbiota (GM) being the most studied ecosystem. Some human milk (HM) bioactive factors, such as HM prebiotic carbohydrates that select for beneficial bacteria, and the specific human milk microbiota (HMM) are emerging as early mediators in the relationship between the development of GM in early life and clinical outcomes. The beneficial role of HM becomes even more crucial for preterm infants, who are exposed to significant risks of severe infection in early life as well as to adverse short and long-term outcomes. When MOM is unavailable or insufficient, donor human milk (DHM) constitutes the optimal nutritional choice. However, little is known about the specific effect of DHM on preterm GM and its potential functional implication on HMM. The purpose of this narrative review is to summarize recent findings on HMM origin and composition and discuss the role of HMM on infant health and development, with a specific focus on preterm infants.
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http://dx.doi.org/10.3390/nu11122944DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6950588PMC
December 2019

Free radicals and neonatal encephalopathy: mechanisms of injury, biomarkers, and antioxidant treatment perspectives.

Pediatr Res 2020 04 26;87(5):823-833. Epub 2019 Oct 26.

Neonatology and Neonatal Intensive Care Unit, St. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Neonatal encephalopathy (NE), most commonly a result of the disruption of cerebral oxygen delivery, is the leading cause of neurologic disability in term neonates. Given the key role of free radicals in brain injury development following hypoxia-ischemia-reperfusion, several oxidative biomarkers have been explored in preclinical and clinical models of NE. Among these, antioxidant enzyme activity, uric acid excretion, nitric oxide, malondialdehyde, and non-protein-bound iron have shown promising results as possible predictors of NE severity and outcome. Owing to high costs and technical complexity, however, their routine use in clinical practice is still limited. Several strategies aimed at reducing free radical production or upregulating physiological scavengers have been proposed for NE. Room-air resuscitation has proved to reduce oxidative stress following perinatal asphyxia and is now universally adopted. A number of medications endowed with antioxidant properties, such as melatonin, erythropoietin, allopurinol, or N-acetylcysteine, have also shown potential neuroprotective effects in perinatal asphyxia; nevertheless, further evidence is needed before these antioxidant approaches could be implemented as standard care.
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http://dx.doi.org/10.1038/s41390-019-0639-6DOI Listing
April 2020

NMR Assays for Estimating the -Acetyl Content of Meningococcal Polysaccharide Serogroup A in Quadrivalent Conjugate Vaccine Formulation.

ACS Omega 2019 Jul 29;4(7):12827-12832. Epub 2019 Jul 29.

Technical R&D, GSK Vaccines S.r.l., Via Fiorentina 1, 53100, Siena, Italy.

The use of multivalent glycoconjugate vaccines has dramatically contributed to reduce the incidence of meningococcal infectious disease. The advanced structural characterization of polysaccharide conjugates leads to enhancements in the quality and control of the products. Here, we report a novel nuclear magnetic resonance (NMR) method to confirm the identity and structural conformity (e.g., -acetyl content) of saccharide antigens that comprise a licensed tetravalent meningococcal serogroups A, C, W, and Y vaccine. For the first time, the NMR methodology is applied on a formulation (licensed vaccine) containing a large excess of excipient (i.e., sucrose) without analytical sample pretreatment. This work confirms the applicability of a rapid and easy NMR assay on a multivalent conjugate vaccine, which might be extended to other combination vaccines that are already licensed or in clinical development.
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http://dx.doi.org/10.1021/acsomega.9b01678DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681974PMC
July 2019

Cerebral Oxygenation Patterns during Electroclinical Neonatal Seizures.

Neuropediatrics 2019 12 26;50(6):408-409. Epub 2019 Jul 26.

Intensive Care Unit, Division of Neonatology, St. Orsola-Malpighi University Hospital, Bologna, Italy.

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http://dx.doi.org/10.1055/s-0039-1693058DOI Listing
December 2019

Hypothermic Oxygenated Machine Perfusion of Liver Grafts from Brain-Dead Donors.

Sci Rep 2019 06 27;9(1):9337. Epub 2019 Jun 27.

General Surgery 2U - Liver Transplant Unit, A.O.U. Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy.

Hypothermic oxygenated machine perfusion (HOPE) was introduced in liver transplantation (LT) to mitigate ischemia-reperfusion injury. Available clinical data mainly concern LT with donors after circulatory-determined death, whereas data on brain-dead donors (DBD) are scarce. To assess the impact of end-ischemic HOPE in DBD LT, data on primary adult LTs performed between March 2016 and June 2018 were analyzed. HOPE was used in selected cases of donor age >80 years, apparent severe graft steatosis, or ischemia time ≥10 hours. Outcomes of HOPE-treated cases were compared with those after static cold storage. Propensity score matching (1:2) and Bayesian model averaging were used to overcome selection bias. During the study period, 25 (8.5%) out of 294 grafts were treated with HOPE. After matching, HOPE was associated with a lower severe post-reperfusion syndrome (PRS) rate (4% versus 20%, p = 0.13) and stage 2-3 acute kidney injury (AKI) (16% versus 42%, p = 0.046). Furthermore, Bayesian model averaging showed lower transaminases peak and a lower early allograft dysfunction (EAD) rate after HOPE. A steeper decline in arterial graft resistance throughout perfusion was associated with lower EAD rate. HOPE determines a significant reduction of ischemia reperfusion injury in DBD LT.
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http://dx.doi.org/10.1038/s41598-019-45843-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6597580PMC
June 2019

Effect of Patent Ductus Arteriosus on Splanchnic Oxygenation at Enteral Feeding Introduction in Very Preterm Infants.

J Pediatr Gastroenterol Nutr 2019 10;69(4):493-497

Neonatal Intensive Care Unit, St Orsola-Malpighi University Hospital.

Because of its possible effect on mesenteric blood flow, the presence of a hemodynamically significant patent ductus arteriosus (PDA) is often of concern for the introduction of enteral feeds in preterm neonates. Near-infrared spectroscopy allows a continuous monitoring of splanchnic oxygenation (SrSO2) and may provide useful hemodynamic information. This observational study evaluated SrSO2 patterns in response to first feed administration in 50 preterm infants <32 weeks' gestation with different ductal status. According to their echocardiographic characteristics, the enrolled infants were divided into the following groups: pulsatile PDA with hemodynamically significant features, restrictive PDA, and no evidence of PDA. The presence of PDA, either with restrictive or hemodynamically significant characteristics, does not significantly affect SrSO2 response to enteral feeding introduction and is not associated with increased rates of gut complications. This finding may provide encouraging evidence in support of early enteral nutrition in very preterm infants with PDA.
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http://dx.doi.org/10.1097/MPG.0000000000002420DOI Listing
October 2019