Publications by authors named "Stefano Ghirardello"

40 Publications

Letter to the Editor RE: Implementation of Delayed Cord Clamping Into Neonatal Algorithms.

Pediatrics 2021 Mar 31. Epub 2021 Mar 31.

Neonatologist, Associated Professor of Pediatrics, Sharp Mary Birch Hospital for Women & Newborns.

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http://dx.doi.org/10.1542/peds.2020-049834ADOI Listing
March 2021

Viscoelastic Coagulation Monitor as a Novel Device to Assess Coagulation at the Bedside. A Single-Center Experience During the COVID-19 Pandemic.

ASAIO J 2021 03;67(3):254-262

From the Department of Anaesthesia and Critical Care, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.

Viscoelastic coagulation monitor (VCM) is a portable device developed to evaluate the viscoelastic properties of whole blood activated by contact with glass. In this study, VCM was employed to analyze the viscoelastic profiles of 36 COVID-19 intensive care patients. Full anticoagulant dose heparin (unfractionated [UFH]; low molecular weight [LMWH]) was administrated to all patients. The association between VCM and laboratory parameters was retrospectively analyzed. The administration of UFH-influenced VCM parameters prolonging clotting time (CT) and clot formation time (CFT) and reducing angle (alpha) and amplitudes of the VCM tracings (A10, A20, and maximum clot firmness [MCF]) compared with LMWH therapy. A tendency toward hypercoagulation was observed by short CT and CFT in patients receiving LMWH. Clotting time was correlated with UFH dose (Spearman's rho = 0.48, p ≤ 0.001), and no correlation was found between CT and LMWH. All VCM tracings failed to show lysis at 30 and 45 minutes, indicating the absence of fibrinolysis. A10, A20, and MCF exhibited very-good to good diagnostic accuracy for detecting platelet count and fibrinogen above the upper reference limit of the laboratory. In conclusion, VCM provided reliable results in COVID-19 patients and was easy to perform with minimal training at the bedside.
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http://dx.doi.org/10.1097/MAT.0000000000001380DOI Listing
March 2021

Assessment of Platelet Thrombus Formation under Flow Conditions in Adult Patients with COVID-19: An Observational Study.

Thromb Haemost 2021 Feb 5. Epub 2021 Feb 5.

Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Background:  Coronavirus disease 2019 (COVID-19) is associated with systemic inflammation, which may dysregulate platelet function. Total Thrombus-Formation Analysis System (T-TAS) is a flow-chamber device that analyses platelet-mediated thrombus formation in capillary channels through the following parameters: (1) the area under the flow-pressure curve (AUC), (2) occlusion start time (OST), time needed to reach OST, and (3) occlusion time (OT), time needed to reach the occlusion pressure.

Methods And Findings:  Sixty-one COVID-19 patients admitted to intensive, subintensive, and low intensive care were prospectively enrolled according to the time of admission: group A (up to 8 days) ( = 18); group B (from 9 to 21 days) ( = 19), and group C ( > 21 days) ( = 24). T-TAS measurements were performed at enrolment and after 7 days. Median OST was similar among groups. AUC was lower in group A compared to B ( = 0.001) and C ( = 0.033). OT was longer in group A compared to B ( = 0.001) and C ( = 0.028). Platelet count (PC) was higher in group B compared to A ( = 0.024). The linear regression showed that OT and AUC were independent from PC in group A (OT: 0.149 [95% confidence interval [CI]: -0.326 to 0.624],  = 0.513 and AUC: 0.005 [95% CI: -0.008 to 0.017],  = 0,447). In contrast, in group B, PC was associated with OT (-0.019 [-0.028 to 0.008],  = 0.023) and AUC (0.749 [0.358-1.139],  = 0,015), similarly to group C. Conversely, patients with different illness severity had similar T-TAS parameters.

Conclusion:  COVID-19 patients display an impaired platelet thrombus formation in the early phase of the disease compared to later stages and controls, independently from illness severity.
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http://dx.doi.org/10.1055/s-0041-1722919DOI Listing
February 2021

Red blood cell transfusions in preterm newborns and neurodevelopmental outcomes at 2 and 5 years of age.

Blood Transfus 2020 Dec 1. Epub 2020 Dec 1.

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan.

Background: Red blood cell (RBC) transfusion is often considered a life-saving measure in preterm neonates. However, it has been associated with detrimental effects on short-term morbidities and, recently, on brain development. The aim of the present study was to evaluate the association between RBC and long-term neurodevelopmental outcome in a cohort of preterm infants.

Materials And Methods: This retrospective cohort study was carried out in the period 2007-2013. Preterm infants with a gestational age (GA) ≤32 weeks and birthweight (BW) <1,500 g were included. Infants underwent Griffiths assessment at 24±6 months corrected age (CA) and at 5±1 years of age. We used a multivariate regression model to assess the association of RBC transfusions and long-term neurodevelopment after controlling for GA, being small for GA, major neonatal morbidities, and socio-economic status. We also evaluated the impact of early RBC administration (within the first 28 days of life) compared to those performed after the first month of life.

Results: We enrolled 644 preterm infants, among whom 54.3% were transfused during their stay in the neonatal intensive care unit (NICU). In infants with a longitudinal follow-up evaluation (n=360), each RBC transfusion was independently associated with a reduction in the Griffiths General Quotient (GQ) by -0.96 (p=0.002) at 24 months CA. Early RBC administration had the biggest impact, especially in children without brain lesions, where the reduction in Griffiths GQ for each additional transfusion was -2.12 (p=0.001) at 24 months CA and -1.31 (p=0.006) at 5 years of age, respectively.

Discussion: In preterm infants, RBC transfusions are associated with long-term neurodevelopmental outcome, with a cumulative effect. Early RBC administration is associated with a greater reduction in Griffiths scores. The impact of RBC transfusion on neurodevelopment is greater at 24 months CA, but persists, although to a lesser degree, at 5 years of age.
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http://dx.doi.org/10.2450/2020.0207-20DOI Listing
December 2020

In Reply to: A Risk Score for Predicting the Incidence of Hemorrhage in Critically Ill Neonates: Development and Validation Study.

Thromb Haemost 2020 Nov 19. Epub 2020 Nov 19.

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

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http://dx.doi.org/10.1055/s-0040-1721316DOI Listing
November 2020

The NeoAPACHE Study Protocol I: Assessment of the Radiographic Pulmonary Area and Long-Term Respiratory Function in Newborns With Congenital Diaphragmatic Hernia.

Front Pediatr 2020 30;8:581809. Epub 2020 Oct 30.

Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

In newborns with congenital diaphragmatic hernia (CDH), the radiographic lung area is correlated with functional residual capacity (FRC) and represents an alternative method to estimate lung hypoplasia. In a cohort of newborn CDH survivors, we retrospectively evaluated the relationship between radiographic lung area measured on the 1st day of life and long-term respiratory function. As a secondary analysis, we compared radiographic lung areas and respiratory function between patients undergoing fetal endoscopic tracheal occlusion (FETO) and patients managed expectantly (non-FETO). Total, ipsilateral, and contralateral radiographic areas were obtained by tracing lung perimeter as delineated by the diaphragm and rib cage, excluding mediastinal structures and herniated organs. Tidal volume (V), respiratory rate (RR), and their Z-Scores when compared to the norm were collected from pulmonary function tests (PFTs) performed at 12 ± 6 months of age. Linear regression analyses using the absolute Z-Score values for each parameter were performed. In CDH survivors, an increase in total and ipsilateral lung area measured at birth was related to a reduction in the absolute Z-Score for V in PFTs ( = 0.046 and = 0.023, respectively), indicating a trend toward an improvement in pulmonary volumes and V normalization. Radiographic lung areas were not significantly different between FETO and non-FETO patients, suggesting a volumetric lung increase due to prenatal intervention. However, the mean Z-Score value for RR was significantly higher in the FETO group ( < 0.001), probably due to impaired diaphragmatic motility in the most severe cases. Further analyses are necessary to better characterize the role of the radiographic pulmonary area in the prognostic evaluation of respiratory function in patients with CDH. This trial was registered at ClinicalTrials.gov with the identifier NCT04396028.
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http://dx.doi.org/10.3389/fped.2020.581809DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7661933PMC
October 2020

Thrombin Generation in Preterm Newborns With Intestinal Failure-Associated Liver Disease.

Front Pediatr 2020 26;8:510. Epub 2020 Aug 26.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Milan, Italy.

Intestinal failure-associated liver disease (IFALD) affects one-fifth of neonates receiving parenteral nutrition (PN) for more than 2 weeks. We aimed to define the effect of IFALD on hemostasis of preterm infants. This is an ancillary analysis of a prospective study aimed at defining coagulation in preterm infants. We included neonates exposed to PN (at least 14 days), in full-enteral feeding. We compared thrombin generation in the presence of thrombomodulin, defined as endogenous thrombin potential-ETP, PT, aPTT between infants with IFALD vs. those without (controls), at birth, and after 30 days. IFALD was defined as conjugated bilirubin ≥1 mg/dl. We enrolled 92 preterm infants (32 IFALD; 60 controls). Cholestatic patients had a lower birthweight, longer exposure to PN, and longer hospitalization. Infants with IFALD showed longer median PT (12.8-vs.-12 sec; = 0.02) and aPTT (39.2-vs.-36.5 sec; = 0.04) than controls, with no difference in ETP. Despite prolonged PTs and aPTTs infants with IFALD had similar ETP than those without.
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http://dx.doi.org/10.3389/fped.2020.00510DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479833PMC
August 2020

The Thromboelastographic Profile at Birth in Very Preterm Newborns with Patent Ductus Arteriosus.

Neonatology 2020 2;117(3):316-323. Epub 2020 Jun 2.

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Background: The role of hemostasis in the closure of patent ductus arteriosus (PDA) in preterm infants is controversial.

Objective: To assess thromboelastography (TEG) at birth in very-low-birth-weight (VLBW) infants affected by PDA.

Methods: This was an ancillary study of a prospective observational study aimed at defining the TEG profile in healthy VLBW infants in the first month of life. In this analysis, we included neonates of <33 weeks' gestational age (GA) with PDA and compared TEG traces based on (1) spontaneous closure versus the need for pharmacological treatment and (2) treatment response. We collected blood samples in the 1st day of life to perform recalcified native-blood TEG (reaction time, maximum amplitude, and lysis at 30 min [Ly30)]), standard coagulation tests, and a full blood count.

Results: We enrolled 151 infants with a PDA at the first echocardiogram; 111 experienced spontaneous PDA closure while 40 required treatment. Mean GA was 29.7 ± 1.7 and 27.6 ± 2.1 weeks, and birth weight was 1,158 ± 256 and 933 ± 263 g in the 2 groups, respectively (p < 0.001). The hemostatic profile was similar between groups. Median hematocrit (44.6 and 48.7%; p = 0.01) and platelet count (187 and 216 × 103/μL; p = 0.04) were lower in the treated group, although differences lost significance after controlling for GA and illness severity in the multivariate analysis. Responders to PDA treatment (n = 20) had a significantly lower median Ly30 than nonresponders (0 and 0.7%; p = 0.02).

Conclusion: TEG at birth does not predict spontaneous PDA closure in preterm newborns. Fibrinolysis is enhanced in nonresponders to PDA treatment; this observation warrants further investigation.
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http://dx.doi.org/10.1159/000507553DOI Listing
June 2020

Iron Homeostasis Disruption and Oxidative Stress in Preterm Newborns.

Nutrients 2020 May 27;12(6). Epub 2020 May 27.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, 20122 Milano, Italy.

Iron is an essential micronutrient for early development, being involved in several cellular processes and playing a significant role in neurodevelopment. Prematurity may impact on iron homeostasis in different ways. On the one hand, more than half of preterm infants develop iron deficiency (ID)/ID anemia (IDA), due to the shorter duration of pregnancy, early postnatal growth, insufficient erythropoiesis, and phlebotomy losses. On the other hand, the sickest patients are exposed to erythrocytes transfusions, increasing the risk of iron overload under conditions of impaired antioxidant capacity. Prevention of iron shortage through placental transfusion, blood-sparing practices for laboratory assessments, and iron supplementation is the first frontier in the management of anemia in preterm infants. The American Academy of Pediatrics recommends the administration of 2 mg/kg/day of oral elemental iron to human milk-fed preterm infants from one month of age to prevent ID. To date, there is no consensus on the type of iron preparations, dosages, or starting time of administration to meet optimal cost-efficacy and safety measures. We will identify the main determinants of iron homeostasis in premature infants, elaborate on iron-mediated redox unbalance, and highlight areas for further research to tailor the management of iron metabolism.
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http://dx.doi.org/10.3390/nu12061554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352191PMC
May 2020

Is placental blood a reliable source for the evaluation of neonatal hemostasis at birth?

Transfusion 2020 05 21;60(5):1069-1077. Epub 2020 Apr 21.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.

Background: Phlebotomy is among the main determinants of anemia of prematurity. Blood sparing policies endorsed umbilical cord blood (here called placental) as an alternative source for laboratory testing. Little is known on the suitability of placental blood to evaluate neonatal hemostasis of newborn infants. We aimed to compare the hemostatic profile of paired placental and infant venous blood, by means of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, antithrombin, protein C, thromboelastography (TEG) and thrombin generation assay (TGA).

Study Design: This was an observational single-center study.

Methods: We collected at birth venous citrated blood from both placental and infant venous source and performed PT, APTT, fibrinogen, antithrombin, protein C, TEG (reaction time-R; kinetics-K alpha angle-α, maximum amplitude-MA and lysis at 30 minutes-LY30), and TGA (endogenous thrombin potential-ETP).

Results: We enrolled 60 neonates with a median gestational age (range) of 37 weeks (28 -41) and birth-weight 2417 g (950-4170). Based on TEG and TGA, placental blood showed a procoagulant imbalance as indicated by lower median R (4.0 vs. 6.1 min; p < 0.001) and K (1.3 vs. 2.2 min; p < 0.001); higher α-angle (69.7 vs. 57.4°; p < 0.001) and ETP (1260 vs. 1078; p = 0.002) than those observed for infant venous blood. PT and APTT did not differ significantly between the two groups.

Conclusions: While placental and neonatal blood samples are equally suitable to measure the standard coagulation tests PT and APTT, placental blood leads to a procoagulant imbalance when testing is performed with TEG or TGA. These effects should be considered when interpreting results stemming from investigation of neonatal hemostasis.
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http://dx.doi.org/10.1111/trf.15785DOI Listing
May 2020

Procoagulant imbalance in preterm neonates detected by thrombin generation procedures.

Thromb Res 2020 01 15;185:96-101. Epub 2019 Nov 15.

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Preterm newborns are considered at risk of acquired coagulopathy and are often prophylactically infused with fresh frozen plasma (FFP) even in the absence of bleeding. To assess the coagulation asset of preterm neonates and the biological plausibility of such infusions, we investigated at birth 87 very low birth weight (≤1500 g) preterm (gestational age <35 weeks) newborns and 64 full-term newborns. Preterm neonates were also investigated at different time-points up to 30 days after birth. Plasma from preterm and full-term neonates were subjected to the measurement of prothrombin and activated partial thromboplastin time (PT, APTT), pro- and anticoagulant factors as well as to thrombin-generation procedures both with and without thrombomodulin. PT and APTT of preterm newborns were longer than those of full-term neonates [PT: 15.9 s (11.7-51.2)-vs-13.8 (11.0-25.4), p < 0.001. APTT: 59.0 (37.8-97.5)-vs- 47.3 (28.1-71.9), p < 0.001] and tended to shortening after 30 days from birth. Thrombin-generation defined as endogenous thrombin potential (ETP) was increased in preterm as compared to full-term neonates at birth [1322 nM·min (474-2384)-vs-1006 (697-1612), p < 0.001] and did not change appreciably over time up to 30 days from birth. In conclusion, plasma from preterm neonates displays a procoagulant imbalance at birth as shown by increasing ETP, despite the prolongation of PT and APTT. The results define preterm newborns as having hyper- rather than hypo-coagulability and argue against the infusion of FFP when given prophylactically and/or based solely on prolongation of PT or APTT.
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http://dx.doi.org/10.1016/j.thromres.2019.11.013DOI Listing
January 2020

Thromboelastographic profiles of healthy very low birthweight infants serially during their first month.

Arch Dis Child Fetal Neonatal Ed 2020 Jul 8;105(4):412-418. Epub 2019 Nov 8.

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Objective: We determined thromboelastographic (TEG) profiles of healthy very low birthweight infants (VLBWIs) of the day of birth and at set intervals during their first month.

Design: Prospective observational study with blinded clinical and laboratory follow-up.

Setting: Level III neonatal intensive care unit (June 2015 to June 2018).

Patients: Consecutive qualifying VLBWIs were enrolled at birth and followed up for 30 days.

Interventions And Main Outcomes Measures: Laboratory (citrated-native TEG, prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, blood count) and clinical variables were retrieved at birth, 3rd-5th, 10th and 30th day of life. Blood samples temporally related to events with a potential hemostatic impact (sepsis, bleeding, platelets/plasma transfusions, ibuprofen/indomethacin administration) were excluded from analysis.

Results: We enrolled 201 VLBWIs and 72 full-term neonates. Sixty-seven of the healthy VLBWIs completed the 30-day follow-up. 541 TEG traces were analysed.On day 1, the median (minimum-maximum) TEG values were as follows: reaction time (R), 8.2 min (1-21.8); kinetics (K), 2.8 min (0.8-16); α angle, 51° (14.2-80.6); maximum amplitude (MA), 54.9 mm (23.9-76.8). PT and APTT were 15.9 s (11.7-51.2) and 59 s (37.8-97.5), respectively. The above parameters suggest minor hypocoagulability compared with term infants. On day 30, the median (minimum-maximum) R was 5 (1-16.9), K 1 (0.8-4.1), α 74.7 (41.1-86.7) and MA 70.2 (35.8-79.7). PT and APTT were 12.1 (10.4-16.6) and 38.8 (29.6-51.4), respectively. Those parameters are consistent with a relatively hypercoagulable phenotype, compared with term infants.

Conclusions: Healthy VLBWIs have a prolonged PT and APTT, but their TEG profiles suggest a relatively balanced hemostatic system, with slight hypocoagulability initially (compared with term neonates), gradually evolving to a somewhat more procoagulant phenotype over the first month.
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http://dx.doi.org/10.1136/archdischild-2019-317860DOI Listing
July 2020

Delayed Cord Clamping in Twin Pregnancies: To Do or Not to Do?

Neonatology 2019 19;116(1):6-7. Epub 2019 Mar 19.

Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy.

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http://dx.doi.org/10.1159/000497327DOI Listing
December 2019

Oxidative Stress and Neonatal Respiratory Extracorporeal Membrane Oxygenation.

Front Physiol 2018 4;9:1739. Epub 2018 Dec 4.

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Oxidative stress is a frequent condition in critically ill patients, especially if exposed to extracorporeal circulation, and it is associated with worse outcomes and increased mortality. The inflammation triggered by the contact of blood with a non-endogenous surface, the use of high volumes of packed red blood cells and platelets transfusion, the risk of hyperoxia and the impairment of antioxidation systems contribute to the increase of reactive oxygen species and the imbalance of the redox system. This is responsible for the increased production of superoxide anion, hydrogen peroxide, hydroxyl radicals, and peroxynitrite resulting in increased lipid peroxidation, protein oxidation, and DNA damage. The understanding of the pathophysiologic mechanisms leading to redox imbalance would pave the way for the future development of preventive approaches. This review provides an overview of the clinical impact of the oxidative stress during neonatal extracorporeal support and concludes with a brief perspective on the current antioxidant strategies, with the aim to focus on the potential oxidative stress-mediated cell damage that has been implicated in both short and long-term outcomes.
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http://dx.doi.org/10.3389/fphys.2018.01739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288438PMC
December 2018

Italian Recommendations for Placental Transfusion Strategies.

Front Pediatr 2018 3;6:372. Epub 2018 Dec 3.

Department of Pediatric Sciences, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.

At delivery, if the cord is not clamped, blood continues to pass from the placenta to the newborn during the first minutes of life, allowing the transfer of 25-35 ml/kg of placental blood to the newborn, depending on gestational age, the timing of cord clamping, the position of the infant at birth, the onset of respiration, and administration of uterotonics to the mother. However, deriving benefits from delayed cord clamping (DCC) are not merely related to placental-to-fetal blood transfusion; establishing spontaneous ventilation before cutting the cord improves venous return to the right heart and pulmonary blood flow, protecting the newborn from the transient low cardiac output, and systemic arterial pressure fluctuations. Recent meta-analyses showed that delayed cord clamping reduces mortality and red blood cell transfusions in preterm newborns and increases iron stores in term newborns. Various authors suggested umbilical cord milking (UCM) as a safe alternative when delayed cord clamping is not feasible. Many scientific societies recommend waiting 30-60 s before clamping the cord for both term and preterm newborns not requiring resuscitation. To improve the uptake of placental transfusion strategies, in 2016 an Italian Task Force for the Management of Umbilical Cord Clamping drafted national recommendations for the management of cord clamping in term and preterm deliveries. The task force performed a detailed review of the literature using the GRADE methodological approach. The document analyzed all clinical scenarios that operators could deal with in the delivery room, including cord blood gas analysis during delayed cord clamping and time to cord clamping in the case of umbilical cord blood banking. The panel intended to promote a more physiological and individualized approach to cord clamping, specifically for the most preterm newborn. A feasible option to implement delayed cord clamping in very preterm deliveries is to move the neonatologist to the mother's bedside to assess the newborn's clinical condition at birth. This option could safely guarantee the first steps of stabilization before clamping the cord and allow DCC in the first 30 s of life, without delaying resuscitation. Contra-indications to placental transfusion strategies are clinical situations that may endanger mother 's health and those that may delay immediate newborn's resuscitation when required.
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http://dx.doi.org/10.3389/fped.2018.00372DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287578PMC
December 2018

Placental Circulation Intact Trial (PCI-T)-Resuscitation With the Placental Circulation Intact vs. Cord Milking for Very Preterm Infants: A Feasibility Study.

Front Pediatr 2018 27;6:364. Epub 2018 Nov 27.

Department of Neuroscience, Psychology, Drug Research and Child Health, Careggi University Hospital of Florence, Florence, Italy.

Preterm newborns receiving briefly delayed cord clamping or cord milking at birth have better neonatal outcomes. However, the time frame in which both these procedures are performed (< 60 s of life) is too short to explore the possible beneficial effects on early infant postnatal adaptation and outcomes of a prolonged transfusion strategy associated with neonatal respiration. We have designed a randomized, multicenter, controlled two-phase study: phase 1 to assess the feasibility of carrying out the protocol in a large randomized trial, and phase 2 to assess the efficacy of bedside assistance with intact placental circulation for 3 min in comparison to cord milking to improve outcome in the neonatal period; we present here the feasibility and safety phase of the study. Outcomes included feasibility (recruitment rate of two patients per month, compliance with the trial interventions, completeness of data collection, >90% of infants receiving echographic assessments in the first 24 h) and safety variables (5 min Apgar score, delivery room intubation rate, CRIB II score, admission temperature, maximum hemoglobin concentration and hematocrit in the first 24 h and maximum serum bilirubin value) in the two study groups. We also evaluated the same safety variables in infants delivered during the study period but not recruited. A total of 40 infants were enrolled. In all cases the protocol was completed and all feasibility outcomes were reached. Infants assisted with an intact placental circulation have a higher 5 min Apgar score but their admission temperature was lower than milked infants. Delivery room intubation rate, CRIB II score and peak serum bilirubin value were comparable in both groups. Infants who were not subjected to a placental transfusion strategy (excluded patients) had a higher delivery room intubation rate with respect to both study groups. Delaying cord clamping until 3 min of life was challenging but feasible and appeared to be safe. However, admission temperature must be strictly monitored and a more efficacious warming system could be implemented to prevent hypothermia during the procedure. Clinicaltrials,gov NCT02671305 (date of registration: 26 JAN 2016). https://clinicaltrials.gov/ct2/show/NCT02671305.
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http://dx.doi.org/10.3389/fped.2018.00364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6277460PMC
November 2018

Role of Lung Function Monitoring by the Forced Oscillation Technique for Tailoring Ventilation and Weaning in Neonatal ECMO: New Insights From a Case Report.

Front Pediatr 2018 1;6:332. Epub 2018 Nov 1.

Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milan, Italy.

Respiratory management during extracorporeal membrane oxygenation (ECMO) is complex. Assessment of lung mechanics might support a patient-tailored ventilatory strategy. We report, for the first time, the use of the forced oscillation technique (FOT) to evaluate lung function during neonatal ECMO to improve the individualization of respiratory support. The patient was a formerly preterm infant at a corrected age of 40 weeks (gestational age 32 weeks) undergoing veno-arterial ECMO for refractory respiratory failure secondary to influenza A (H1N1) pneumonia. We used the FOT as a bedside non-invasive tool for daily monitoring of lung mechanics, from ECMO day 6 (E6) until decannulation. A small-amplitude, 5-Hz oscillatory pressure was overimposed on the ventilation waveform at the airway opening during positive end-expiratory pressure (PEEP) trials. From E6 to E9, lung mechanics changes with PEEP indicated a largely de-recruited and easily over-distendable lung that was not recruitable by applying lung-protective PEEP values. After surfactant and steroid administration, oscillatory reactance (Xrs) values began improving, suggesting a more recruited and pressure-recruitable lung. On E11, despite the lack of improvement in the radiographic appearance of the thorax, the FOT measurements showed a more recruited lung. Weaning from ECMO was started, and the patient was extubated within 48 h. The decannulation was successful, and the patient was extubated within 48 h after ECMO weaning. First-year respiratory and neurodevelopmental follow-up evaluation was unremarkable. This report suggests the potential usefulness of the FOT for monitoring the lung mechanics of ventilated newborns during ECMO to achieve individualized respiratory management. Such tailoring might improve neonatal outcomes and support clinicians with the establishment of a timely and safer weaning approach. These findings need to be verified on a larger population.
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http://dx.doi.org/10.3389/fped.2018.00332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6221953PMC
November 2018

The intra-assay reproducibility of thromboelastography in very low birth weight infants.

Early Hum Dev 2018 12 9;127:48-52. Epub 2018 Oct 9.

Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Italy. Electronic address:

Background And Aims: Despite the potential benefits of thromboelastography (TEG) for bedside hemostatic assessment in critical care settings, its accuracy remains to be determined, especially in critically ill neonates. We determined the intra-assay reproducibility of TEG parameters: Reaction time (R), clot kinetics (K) and Maximum Amplitude (MA) in a cohort of very low birth weight (VLBW) infants.

Study Design: Observational study.

Subjects: One hundred VLBW newborns.

Outcome Measures: We performed TEG duplicate measurements for blood samples from VLBW newborns. To assess for correlation, we calculated the coefficients of correlation by plotting the values of the first vs the second measurement. Paired samples were compared with t-test and the coefficient of variation (CV) on paired results was also calculated as a measure of variability. To evaluate the agreement between duplicates, Bland-Altman (BA) analysis was performed.

Results: We evaluated 228 TEG pairs. Both the coefficient of correlation and the BA analysis showed an acceptable level of agreement between duplicates. TEG variability (CV, mean ± SD) was highest for K (10.4%, ±12.9), lowest for MA (3.6%, ±8.0) and moderate for R (7.9%, ±9.0). The results from ANOVA one-way analysis describe different variability trends: K-CV increased at higher values, while MA-CV and R-CV increased at lower values.

Conclusions: In VLBW newborns, the agreement between TEG duplicate measurements for R and MA parameters is adequate for clinical purposes. TEG is a promising tool to quickly assess hemostasis ensuring a significant blood sparing in critically ill neonates.
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http://dx.doi.org/10.1016/j.earlhumdev.2018.10.004DOI Listing
December 2018

Delayed Cord Clamping Increased the Need for Phototherapy Treatment in Infants With AB0 Alloimmunization Born by Cesarean Section: A Retrospective Study.

Front Pediatr 2018 19;6:241. Epub 2018 Sep 19.

Neonatal Intensive Care Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.

To compare the effect of Delayed Cord Clamping (DCC) to Immediate Cord Clamping (ICC) on phototherapy treatment in a cohort of cesarean-delivered newborns with AB0-alloimmunization. In a retrospective cohort study neonates with Gestational Age (GA) ≥ 35 weeks and diagnosed with AB0-alloimmunization before implementation of DCC (ICC group) were compared with neonates born after implementation (DCC group). The primary outcome was the need for phototherapy. Secondary outcomes included hospital stay, readmission rate, need for extra intravenous fluids, maximum bilirubin concentration, and hours of life at bilirubin peak. We used regression models to adjust for weight loss, type of feeding, birth weight, and gestational age. In total 336 neonates were included, of which 192 neonates in the ICC group and 144 in the DCC group. There were no differences in basic characteristics between the two groups except for birth weight (ICC 3193 ± 468 g vs. DCC 3053 ± 446 g, = 0.01) and GA (ICC 38.2 ± 1 weeks of GA, vs. DCC 37.9 ± 1 weeks of GA; = 0.01). When adjusted for confounding factors, after implementation of DCC, significantly more infants with AB0 alloimmunization needed phototherapy (22.4% vs. 36.8%, RR 1.61 CI: 1.15-2.28; = 0.006; Number Needed to Harm 7), needed to stay longer in hospital (20.3% vs. 30.5%, RR 1.53 CI: 1.05-2.23; = 0.03). The maximum bilirubin was higher (11.4 ± 4.0 mg/dl vs. 12.9 ± 3.5 mg/dl, < 0.001) and occurred later [74 (67-92) hours vs. 84 (70-103) hours; = 0.04]. There was no difference in the need for intravenous fluids (1.6% vs. 4.9%; not significant) and readmissions (1.6% vs. 3.5%; not significant). Infants with AB0 alloimmunization needed more often phototherapy and were admitted longer after implementation of DCC policy. Further studies are needed to see whether the benefit of DCC outweighs the increased morbidity, admission days, and related hospital costs.
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http://dx.doi.org/10.3389/fped.2018.00241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6157444PMC
September 2018

Is the new, noninvasive, continuous cardiorespiratory monitoring reliable during neonatal ECMO?

Heart Lung 2018 11 3;47(6):638-645. Epub 2018 Aug 3.

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milano, Italy. Electronic address:

Background: Advances in cardiorespiratory monitoring have made the extracorporeal membrane oxygenation (ECMO) technique safer for the patient. Noninvasive, continuous tools are available, although data on their applications in the neonatal ECMO setting are lacking.

Objective: We retrospectively described the neonatal clinical application of this continuous, noninvasive ECMO monitor and compared the analyzed parameters from those derived from blood gas analysis.

Materials And Methods: We performed 897 h of cardiorespiratory monitoring during neonatal venoarterial-ECMO (VA-ECMO) for four patients affected by (cardio-) respiratory failure, to compare the reliability of a noninvasive, continuous monitoring Spectrum M4® (M4) (Spectrum Medical, Gloucester, England) to an invasive, intermittent co-monitoring with blood gas analyzer (Radiometer Medical ApS, Brønshøj, Denmark).

Results: A range of 117 pairs (time-matched BGA-derived vs. M4-derived parameters) was retrospectively analyzed. T-test, linear regression and Bland-Altman analysis for hemoglobin, hematocrit, venous oxygen saturation, oxygen delivery, oxygen consumption, oxygen extraction ratio, oxygen partial pressure, and carbon dioxide partial pressure showed a strong relationship between the two monitors for all parameters analyzed (p < 0.0001).

Conclusions: Continuous, noninvasive cardiorespiratory monitoring appears to be feasible and reliable, although its accuracy needs to be verified in a more extensive cohort.
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http://dx.doi.org/10.1016/j.hrtlng.2018.06.007DOI Listing
November 2018

Start a Neonatal Extracorporeal Membrane Oxygenation Program: A Multistep Team Training.

Front Pediatr 2018 29;6:151. Epub 2018 May 29.

Neonatal Intensive Care Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.

Extracorporeal membrane oxygenation (ECMO) is a complex life-saving support for acute cardio-respiratory failure, unresponsive to medical treatment. Emergency events on ECMO are rare but require immediate and proficient management. Multidisciplinary ECMO team members need to acquire and maintain over time cognitive, technical and behavioral skills, to safely face life-threatening clinical scenarios. A multistep educational program was delivered in a 4-year period to 32 ECMO team members, based on guidelines from the Extracorporeal Life Support Organization. A first traditional module was provided through didactic lectures, hands-on water drills, and laboratory animal training. The second phase consisted of a multi-edition high-fidelity simulation-based training on a modified neonatal mannequin (SimNewB®). In each session, participants were called to face, in small groups, ten critical scenarios, followed by debriefing time. Trainees underwent a pre-test for baseline competency assessment. Once completed the full training program, a post-test was administered. Pre- and post-test scores were compared. Trainees rated the educational program through survey questionnaires. 28 trainees (87.5%) completed the full educational program. ECMO staff skills improved from a median pre-test score of 7.5/18 (IQR = 6-11) to 14/18 (IQR = 14-16) at post-test ( < 0.001, Wilcoxon rank test). All trainees highly rated the educational program and its impact on their practice. They reported high-fidelity simulations to be beneficial to novice learners as it increased self-confidence in ECMO-emergencies (according to 100% of surveyed), theoretical knowledge (61.5%) and team-work/communicative skills (58%). The multistep ECMO team training increased staff' knowledge, technical skills, teamwork, and self-confidence, allowing the successful development of a neonatal respiratory ECMO program. Conventional training was perceived as relevant in the early phase of the program development, while the active learning emerged to be more beneficial to master ECMO knowledge, specific skills, and team performance.
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http://dx.doi.org/10.3389/fped.2018.00151DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986935PMC
May 2018

Serum creatinine during physiological perinatal dehydration may estimate individual nephron endowment.

Eur J Pediatr 2018 Sep 1;177(9):1383-1388. Epub 2018 Feb 1.

Neonatal Intensive Care Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, University of Milan, via Commenda 12, 20122, Milan, Italy.

It is well known that the nephron endowment of healthy subjects is highly variable and that individual nephron mass has potentially important implications both in health and disease. However, nephron count is technically impossible in living subjects. Based on the observation of an increase in serum creatinine (sCr) in otherwise healthy newborns with solitary kidney during the physiological perinatal dehydration, we hypothesized that perinatal sCr might be helpful in identifying healthy subjects with a reduced nephron mass. In the framework of a study on blood pressure in babies (NeoNeph), sCr of normal Caucasian neonates was determined 48-96 h after birth and their association with a family history of arterial hypertension (AH) was analyzed. SCr was determined in 182 normal newborns (90 males) at a mean of 61 ± 8 h after birth (range 46-82). Newborns with paternal AH had a higher mean sCr (0.97 + 0.28 mg/dL) then newborns without paternal AH (0.73 + 0.28 mg/dL; p = 0.006). No differences in mean sCr were found in relation with mother or grandparent's history of AH.

Conclusion: The association between parental AH and high sCr during perinatal dehydration supports the hypothesis that the latter is a promising tool for identifying normal subjects with a reduced nephron mass with potential important implications in prevention and in understanding the individual outcome of renal and extrarenal diseases (including AH). What is Known: • Nephron endowment of healthy subjects is highly variable and individual nephron mass has potentially important implications both in health and disease however nephron count is not feasible in living subjects. What is New: • Serum creatinine during perinatal dehydration is a possible biomarker for identifying normal subjects with a reduced nephron mass.
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http://dx.doi.org/10.1007/s00431-018-3087-0DOI Listing
September 2018

Reference ranges of thromboelastography in premature neonates? Still a long way to go.

Early Hum Dev 2018 01 8;116:95-96. Epub 2017 Dec 8.

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Via Commenda 12, 20122 Milano, Italy.

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http://dx.doi.org/10.1016/j.earlhumdev.2017.12.005DOI Listing
January 2018

Placental Transfusion Strategies in Italy: A Nationwide Survey of Tertiary-Care Delivery Wards.

Am J Perinatol 2017 06 6;34(7):722-728. Epub 2017 Jan 6.

Neonatal Intensive Care Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milano, Italy.

 Delayed umbilical cord clamping and cord milking are placental transfusion strategies that produce higher iron stores and better hemodynamic conditions in a newborn. We aimed to evaluate their current practice in tertiary-care delivery wards in Italy.  A multiple-choice questionnaire was e-mailed to all the 101 Italian tertiary-care delivery wards. The comparative analysis between categorical variables was performed by the χ test.  We obtained an 85% (86/101) response rate. Where placental transfusion strategies were applied, in 61% of cases they were performed in less than half of deliveries. Obstetric-neonatal guidelines were available in 21% of the centers. Where they were available, application of delayed clamping and milking was significantly more frequent and clamping time was longer.  This first Italian nationwide survey on placental transfusion strategies showed low application rate and variability in knowledge and execution. Availability of obstetric-neonatal guidelines, knowledge of benefits, and cooperation within the delivery team were associated with enhanced implementation.
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http://dx.doi.org/10.1055/s-0036-1597995DOI Listing
June 2017

Effects of Red Blood Cell Transfusions on the Risk of Developing Complications or Death: An Observational Study of a Cohort of Very Low Birth Weight Infants.

Am J Perinatol 2017 01 1;34(1):88-95. Epub 2016 Jun 1.

Neonatal intensive Care Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milan, Italy.

 The aim of this study was to evaluate the association between red blood cell (RBC) transfusions on the risk of death, retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.  This is an observational study. Data were entered prospectively into the study database at the time of the first transfusion. Clinical characteristics, adverse events, and outcomes of the patients transfused in the first 28 days of life were compared with the population of VLBW infants not transfused during the same period. The association among birth weight, gestational age, comorbidities, and the number of transfusions was estimated with a Poisson regression model. The association between the composite outcome and the occurrence of death, ROP, or BPD separately considered and a set of covariates was estimated with a logistic regression model.  We enrolled 641 VLBW infants, 42% of whom were transfused. Transfusions were associated with the risk of developing the composite outcome, independently from other conditions; this risk correlated with several transfusions ≥ 3 (odds ratio: 5.88, 95% confidence interval: 2.74-12.6). ROP and BPD were associated with several transfusions ≥ 3.  We observed an association between RBC transfusions and the composite risk of death or ROP, BPD, and NEC.
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http://dx.doi.org/10.1055/s-0036-1584300DOI Listing
January 2017

Exchange Transfusion in the Treatment of Neonatal Septic Shock: A Ten-Year Experience in a Neonatal Intensive Care Unit.

Int J Mol Sci 2016 May 9;17(5). Epub 2016 May 9.

Neonatal Intensive Care Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Via della Commenda 12, 20122 Milan, Italy.

Septic shock, occurring in about 1% of neonates hospitalized in neonatal intensive care unit (NICU), is a major cause of death in the neonatal period. In the 1980s and 90s, exchange transfusion (ET) was reported by some authors to be effective in the treatment of neonatal sepsis and septic shock. The main aim of this retrospective study was to compare the mortality rate of neonates with septic shock treated only with standard care therapy (ScT group) with the mortality rate of those treated with ScT and ET (ET group). All neonates with septic shock admitted to our NICU from 2005 to 2015 were included in the study. Overall, 101/9030 (1.1%) neonates had septic shock. Fifty neonates out of 101 (49.5%) received one or more ETs. The mortality rate was 36% in the ET group and 51% in the ScT group (p = 0.16). At multivariate logistic regression analysis, controlling for potentially confounding factors significantly associated with death (gestational age, serum lactate, inotropic drugs, oligoanuria), ET showed a marked protective effect (Odds Ratio 0.21, 95% Confidence Interval: 0.06-0.71; p = 0.01). The lack of observed adverse events should encourage the use of this procedure in the treatment of neonates with septic shock.
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http://dx.doi.org/10.3390/ijms17050695DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881521PMC
May 2016

Cord blood platelet gel treatment of dystrophic recessive epidermolysis bullosa.

BMJ Case Rep 2015 Jan 8;2015. Epub 2015 Jan 8.

Neonatal Intensive Care Unit, Department of Clinical Science and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.

Epidermolysis bullosa (EB) is comprised of a group of hereditary mechanobullous disorders that are characterised by extremely fragile skin and mucous membranes. This results in blister formation and non-healing wounds. This case report describes the results of an innovative treatment of two large skin lesions in a newborn with dystrophic recessive EB (DEB) who experienced bacterial superinfections and progressive anaemisation. The lesions were treated with platelet gels derived from allogeneic cord blood (cord blood platelet gel, CBPGs). The skin lesions were clinically evaluated and treated with CBPG weekly until they completely healed. The first and second lesion required CBPG applications for 2 and 4 weeks, respectively. Both lesions were monitored weekly for 6 weeks after the last CBPG application, and no significant relapses were observed during the follow-up period. This case indicates that CBPG is an effective and safe therapeutic option for managing newborns with DEB, particularly as treatment and prevention of fluid loss and superinfection.
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http://dx.doi.org/10.1136/bcr-2014-207364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4289807PMC
January 2015

Congenital central diabetes insipidus and optic atrophy in a Wolfram newborn: is there a role for WFS1 gene in neurodevelopment?

Ital J Pediatr 2014 Sep 26;40:76. Epub 2014 Sep 26.

Neonatal Intensive Care Unit Department of Clinical Sciences and Community Health, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Background: Wolfram syndrome (WS) is an autosomal recessive neurodegenerative disorder characterized by diabetes mellitus (DM), optic atrophy (OA), central diabetes insipidus (CDI) and deafness (D). The phenotype of the disease has been associated with several mutations in the WFS1 gene, a nuclear gene localized on chromosome 4. Since the discovery of the association between WFS1 gene and Wolfram syndrome, more than 150 mutations have been identified in WS patients. We previously described the first case of perinatal onset of Wolfram syndrome newborn carrying a segmental uniparental heterodysomy affecting the short arm of chromosome 4 responsible for a significant reduction in wolframin expression. Here we review and discuss the pathophysiological mechanisms that we believe responsible for the perinatal onset of Wolfram syndrome as these data strongly suggest a role for WFS1 gene in foetal and neonatal neurodevelopment.

Case Presentation: We described a male patient of 30 weeks' gestation with intrauterine growth restriction and poly-hydramnios. During the first days of life, the patient showed a 19% weight loss associated with polyuria and hypernatremia. The presence of persistent hypernatremia (serum sodium 150 mEq/L), high plasma osmolarity (322 mOsm/L) and low urine osmolarity (190 mOsm/l) with a Uosm/Posm ratio < 1 were consistent with CDI. The diagnosis of CDI was confirmed by the desmopressin test and the brain magnetic resonance imaging (MRI) at 34 weeks of age, that showed the lack of posterior pituitary hyperintense signal. In addition, a bilateral asymmetrical optic nerve hypoplasia associated with right orbital bone hypoplasia was observed, suggesting the diagnosis of WF. During the five years follow-up the patient did not developed glucose intolerance or diabetes mellitus. By the end of the second year of life, primary non-autoimmune central hypothyroidism and mild neurodevelopment retardation were diagnosed.

Conclusions: The analysis of our case, in the light of the most recent literature, suggests a possible role for WFS1 gene in the development of certain brain structures during the fetal period. Wolfram syndrome should be considered in the differential diagnosis of the rare cases of congenital central diabetes insipidus developed in the neonatal period.
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http://dx.doi.org/10.1186/s13052-014-0076-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4422421PMC
September 2014

Fresh frozen plasma use in the NICU: a prospective, observational, multicentred study.

Arch Dis Child Fetal Neonatal Ed 2014 Jul 19;99(4):F303-8. Epub 2014 Mar 19.

Objectives: To examine the use of fresh frozen plasma (FFP) in Italian neonatal intensive care units (NICUs); specifically to quantify compliance with guideline recommendations and to evaluate the relationship between coagulation tests and subsequent bleeding episodes.

Design: Prospective, observational study.

Setting: Seventeen Italian NICUs.

Patients And Methods: Over a period of 12 months, for all neonates that received FFP we recorded specific characteristics, pretransfusion and post-transfusion laboratory test of haemostasis, and details of all haemorrhagic events.

Results: Among 3506 NICU admissions, 290 (8.2%) received one or more FFP transfusions during their hospital stay. Of these, 37% received FFP because of active bleeding and 63% received FFP prophylactically with the intention of preventing haemorrhage. A total of 609 FFP transfusions were administered (mean 2.1/transfused patient-range 1-25). Using previously agreed upon criteria, we judged that 60% of the 609 FFP transfusions were not compliant with guideline recommendations. By logistic regression, abnormalities in the prothrombin time, activated partial thromboplastin time, fibrinogen and platelet count were not independently associated with bleeding episodes.

Conclusions: FFP transfusion is a relatively frequent intervention in the NICU. In the present analysis, we found a remarkably high proportion of FFP transfusions given to non-bleeding neonates for indications not compliant with guideline recommendations. Platelet counts and coagulation studies were poor predictors of clinical bleeding.
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http://dx.doi.org/10.1136/archdischild-2013-304747DOI Listing
July 2014