Publications by authors named "Giovanni Vento"

129 Publications

Reply to: The need for evidence-based treatment decisions in spinal muscular atrophy type 0.

Ann Clin Transl Neurol 2021 Sep 21. Epub 2021 Sep 21.

Neonatology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

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http://dx.doi.org/10.1002/acn3.51458DOI Listing
September 2021

Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial.

Trials 2021 Jul 26;22(1):492. Epub 2021 Jul 26.

Dipartimento Universitario Scienze della Vita e Sanità Pubblica. Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.

Background: Tactile maneuvers stimulating spontaneous respiratory activity in preterm infants are recommended since birth, but data on how and how often these maneuvers are applied in clinical practice are unknown. In the last years, most preterm newborns with respiratory failure are preferentially managed with non-invasive respiratory support and by stimulating spontaneous respiratory activity from the delivery room and in neonatal intensive care unit (NICU), in order to avoid the risks of intubation and prolonged mechanical ventilation.

Methods: Preterm infants with gestational age < 31 weeks not intubated in the delivery room and requiring non-invasive respiratory support at birth will be eligible for the study. They will be randomized and allocated to one of two treatment groups: (1) the study group infants will be subject to the technique of respiratory facilitation within the first 24 h of life, according to the reflex stimulations, by the physiotherapist. The newborn is placed in supine decubitus and a slight digital pressure is exerted on a hemithorax. The respiratory facilitation technique will be performed for about three minutes and repeated for a total of 4/6 times in sequence, three times a day until spontaneous respiratory activity is achieved; thus, no respiratory support is required; (2) the control group infants will take part exclusively in the individualized postural care program. They will perform the technique of respiratory facilitation and autogenous drainage.

Objective: To evaluate the efficacy of early respiratory physiotherapy in reducing the incidence of intubation and mechanical ventilation in the first week of life (primary outcome).

Discussion: The technique of respiratory facilitation is based on reflex stimulations, applied early to preterm infant. Slight digital pressure is exerted on a "trigger point" of each hemithorax, to stimulate the respiratory activity with subsequent increase of the ipsilateral pulmonary minute ventilation and to facilitate the contralateral pulmonary expansion. This mechanism will determine the concatenation of input to all anatomical structures in relation to the area being treated, to promote spontaneous respiratory activity and reducing work of breathing, avoiding or minimizing the use of invasive respiratory support.

Trial Registration: UMIN-CTR Clinical Trial UMIN000036066. Registered on March 1, 2019. Protocol 1. https://www.umin.ac.jp/ctr.
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http://dx.doi.org/10.1186/s13063-021-05446-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314465PMC
July 2021

Neonatal Lung Ultrasound and Surfactant Administration: A Pragmatic, Multicenter Study.

Chest 2021 Jul 19. Epub 2021 Jul 19.

Neonatal Intensive Care Unit, Vittore Buzzi Children's Hospital, Milan, Italy.

Background: Previous research shows that a lung ultrasound score (LUS) can anticipate CPAP failure in neonatal respiratory distress syndrome.

Research Question: Can LUS also predict the need for surfactant replacement?

Study Design And Methods: Multicenter, pragmatic study of preterm neonates who underwent lung ultrasound at birth and those given surfactant by masked physicians, who also were scanned within 24 h from administration. Clinical data and respiratory support variables were recorded. Accuracy of LUS, oxygen saturation to Fio ratio, Fio, and Silverman score for surfactant administration were evaluated using receiver operating characteristic curves. The simultaneous prognostic values of LUS and oxygen saturation to Fio ratio for surfactant administration, adjusting for gestational age (GA), were analyzed through a logistic regression model.

Results: Two hundred forty infants were enrolled. One hundred eight received at least one dose of surfactant. LUS predicted the first surfactant administration with an area under the receiver operating characteristic curve (AUC) of 0.86 (95% CI, 0.81-0.91), cut off of 9, sensitivity of 0.79 (95% CI, 0.70-0.86), specificity of 0.83 (95% CI, 0.76-0.89), positive predictive value of 0.79 (95% CI, 0.71-0.87), negative predictive value of 0.82 (95% CI, 0.75-0.89), positive likelihood ratio of 4.65 (95% CI, 3.14-6.89), and negative likelihood ratio of 0.26 (95% CI, 0.18-0.37). No significant difference was shown among different GA groups: 25 to 27 weeks' GA (AUC, 0.91; 95% CI, 0.84-0.99), 28 to 30 weeks' GA (AUC, 0.81; 95% CI, 0.72-0.91), and 31 to 33 weeks' GA (AUC, 0.88; 95% CI, 0.79-0.95), respectively. LUS declined significantly within 24 h in infants receiving one surfactant dose. When comparing Fio, oxygen saturation to Fio ratio, LUS, and Silverman scores as criteria for surfactant administration, only the latter showed a significantly poorer performance. The combination of oxygen saturation to Fio ratio and LUS showed the highest predictive power, with an AUC of 0.93 (95% CI, 0.89-0.97), regardless of the GA interval.

Interpretation: LUS is a reliable criterion to administer the first surfactant dose regardless of GA. Its association with oxygen saturation to Fio ratio significantly improves the prediction power for surfactant need.
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http://dx.doi.org/10.1016/j.chest.2021.06.076DOI Listing
July 2021

A novel homozygous variant in JAM3 gene causing hemorrhagic destruction of the brain, subependymal calcification, and congenital cataracts (HDBSCC) with neonatal onset.

Neurol Sci 2021 Nov 22;42(11):4759-4765. Epub 2021 Jul 22.

Università Cattolica del Sacro Cuore, Rome, Italy.

Background: JAM3 gene, located on human chromosome 11q25, encodes a member of the junctional adhesion molecule (JAM) family. Mutations of this gene are associated with hemorrhagic destruction of the brain, subependymal calcification, and congenital cataracts (HDBSCC).

Case Report: Herein, we present a newborn male with a prenatal suspicion of bilateral cataracts but without fetal ultrasound findings of cortical malformations. He was postnatally diagnosed with a clinical picture of HDBSCC and Early-onset Developmental and Epileptic Encephalopathy (DEE), associated to a homozygous variant of JAM3 gene.

Conclusion: Identification of this variant in affected individuals has implications for perinatal and postnatal management and genetic counseling. To the best of our knowledge, this is the first case reported of a child with a JAM3 variant in Italy, from a different ethnic background than the other reported children until now (Saudi Arabian, Turkish, Afghani, and Moroccan origin). JAM3 screening could be requested in prenatal diagnosis of fetal congenital cataracts and included in Next-Generation DNA Sequencing panels.
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http://dx.doi.org/10.1007/s10072-021-05480-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295029PMC
November 2021

Extra-uterine growth restriction in preterm infants: Neurodevelopmental outcomes according to different definitions.

Eur J Paediatr Neurol 2021 Jul 24;33:135-145. Epub 2021 Jun 24.

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy; Università Cattolica Del Sacro Cuore, Rome, Italy.

Aim: Extra-uterine Growth Restriction (EUGR) is common among preterm infants. Two types of EUGR definitions are still now available: cross-sectional definitions and longitudinal ones. In a cohort of very preterm infants, we aimed to evaluate which definition could better predict neurodevelopmental outcomes at 2 years of corrected age. We used Italian Neonatal Study Charts (INeS) growth charts and INTERGROWTH-21st (IG-21) standard charts and compared results.

Method: We restrospectively collected data from clinical charts of 324 preterm newborns with a gestational age ≤30 weeks born from 2012 to 2017. Then we compared forty-eight definitions (24 cross-sectional and 24 longitudinal) of EUGR, in term of neurodevelopmental outcomes at 2 years of corrected age.

Results: We included in the study 254 preterm infants, whose clinical information met the enrolment criteria. Nineteen out of 48 definitions of EUGR were significantly predictive both for Griffith's Development Quotient (GDQ) and Neurodevelopment Impairment (NDI). Among these, longitudinal definitions appeared to have a higher negative predictive value for NDI than cross-sectional ones. Furthermore, infants with EUGR appeared to have a lower cognitive score than their peers without EUGR.

Interpretation: A loss of Zs > 1 SDS in weight and head circumference, calculated from when physiological weight loss is over and identified as soon as possible rather than at discharge, better predicts neurodevelopmental outcomes of preterm infants.
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http://dx.doi.org/10.1016/j.ejpn.2021.06.004DOI Listing
July 2021

Refining the mutational spectrum and gene-phenotype correlates in pontocerebellar hypoplasia: results of a multicentric study.

J Med Genet 2021 Mar 5. Epub 2021 Mar 5.

Unit of Neuromuscular and Neurodegenerative Diseases, Department of Neuroscience and Neurorehabilitation, IRCCS Bambino Gesù Children's Hospital, Roma, Italy.

Background: Pontocerebellar hypoplasias (PCH) comprise a group of genetically heterogeneous disorders characterised by concurrent hypoplasia of the pons and the cerebellum and variable clinical and imaging features. The current classification includes 13 subtypes, with ~20 known causative genes. Attempts have been made to delineate the phenotypic spectrum associated to specific PCH genes, yet clinical and neuroradiological features are not consistent across studies, making it difficult to define gene-specific outcomes.

Methods: We performed deep clinical and imaging phenotyping in 56 probands with a neuroradiological diagnosis of PCH, who underwent NGS-based panel sequencing of PCH genes and MLPA for rearrangements. Next, we conducted a phenotype-based unsupervised hierarchical cluster analysis to investigate associations between genes and specific phenotypic clusters.

Results: A genetic diagnosis was obtained in 43 probands (77%). The most common causative gene was , which accounted for nearly half cases (45%) and was mutated in females and occasionally in males. The European founder mutation p.Ala307Ser in and pathogenic variants in accounted for 18% and 9% of cases, respectively. , and were mutated in single patients. We were able to confirm only few previously reported associations, including jitteriness and clonus with and lower motor neuron signs with . When considering multiple features simultaneously, a clear association with a phenotypic cluster only emerged for .

Conclusion: represents the major PCH causative gene in Italy. Phenotypic variability associated with the most common genetic causes of PCH is wider than previously thought, with marked overlap between and -associated disorders.
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http://dx.doi.org/10.1136/jmedgenet-2020-107497DOI Listing
March 2021

Strict glycaemic control in very low birthweight infants using a continuous glucose monitoring system: a randomised controlled trial.

Arch Dis Child Fetal Neonatal Ed 2021 May 26. Epub 2021 May 26.

Child Health Area, University Hospital Agostino Gemelli Department of Woman and Child Health Sciences, Rome, Lazio, Italy.

Objective: To evaluate the efficacy of a strict glycaemic control protocol using a continuous glucose monitoring (CGM) in infants at high risk of dysglycaemia with the aim of reducing the number of dysglycaemic episodes.

Design: Randomised controlled trial.

Setting: Neonatal intensive care unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome.

Patients: All infants <1500 g fed on parental nutrition (PN) since birth were eligible. A total of 63 infants were eligible and 48 were randomised.

Intervention: All participants wore a CGM sensor and were randomised in two arms with alarms set at different cut-off values (2.61-10 mmol/L (47-180 mg/dL) vs 3.44-7.78 mmol/L (62-140 mg/dL)), representing the operative threshold requiring modulation of glucose infusion rate according to an innovative protocol.

Main Outcome Measures: The primary outcome was the number of severe dysglycaemic episodes (<2.61 mmol/L (47 mg/dL) or >10 mmol/L (180 mg/dL)) in the intervention group versus the control group, during the monitoring time.

Results: We enrolled 47 infants, with similar characteristics between the two arms. The number of dysglycaemic episodes and of infants with at least one episode of dysglycaemia was significantly lower in the intervention group (strict group): respectively, 1 (IQR 0-2) vs 3 (IQR 1-7); (p=0.005) and 12 (52%) vs 20 (83%); p=0.047. Infants managed using the strict protocol had a higher probability of having normal glycaemic values: relative risk 2.87 (95% CI 1.1 to 7.3). They spent more time in euglycaemia: 100% (IQR 97-100) vs 98% (IQR 94-99), p=0.036. The number needed to treat to avoid dysglycaemia episodes is 3.2 (95% CI 1.8 to 16.6).

Conclusion: We provide evidence that CGM, combined with a protocol for adjusting glucose infusion, can effectively reduce the episodes of dysglycaemia and increase the percentage of time spent in euglycaemia in very low birthweight infants receiving PN in the first week of life.
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http://dx.doi.org/10.1136/archdischild-2020-320540DOI Listing
May 2021

Ventriculosubgaleal shunt and neuroendoscopic lavage: refining the treatment algorithm of neonatal post-hemorrhagic hydrocephalus.

Childs Nerv Syst 2021 May 20. Epub 2021 May 20.

Pediatric Neurosurgery, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Agostino Gemelli, 8, 00168, Rome, Italy.

Background: The optimal management of neonatal post-hemorrhagic hydrocephalus (PHH) is still debated, though several treatment options have been proposed. In the last years, ventriculosubgaleal shunt (VSgS) and neuroendosdcopic lavage (NEL) have been proposed to overcome the drawbacks of more traditional options, such as external ventricular drainage and ventricular access device.

Methods: We retrospectively reviewed neonates affected by PHH treated at our institution since September 2012 to September 2020. Until 2017 patients received VSgS as initial treatment. After the introduction of NEL, this treatment option was offered to patients with large intraventricular clots. After NEL, VSgS was always placed. Primary VSgS was reserved to patients without significant intraventricular clots and critically ill patients that could not be transferred to the operating room and undergo a longer surgery.

Results: We collected 63 babies (38 males and 25 females) with mean gestational age of 27.8 ± 3.8SD weeks (range 23-38.5 weeks) and mean birthweight of 1199.7 ± 690.6 SD grams (range 500-3320 g). In 6 patients, hemorrhage occurred in the third trimester of gestation, while in the remaining cases hemorrhage complicated prematurity. This group included 37 inborn and 26 outborn babies. Intraventricular hemorrhage was classified as low grade (I-II according to modified Papile grading scale) in 7 cases, while in the remaining cases the grade of hemorrhage was III to IV. Mean age at first neurosurgical procedure was 32.2 ± 3.6SD weeks (range 25.4-40 weeks). Death due to prematurity occurred in 5 patients. First-line treatment was VSgS in 49 patients and NEL in the remaining 14 cases. Mean longevity of VSgS was 30.3 days (range 10-97 days) in patients finally requiring an additional treatment of hydrocephalus. Thirty-two patients required one to three redo VSgS. Interval from initial treatment to permanent shunt ranged from 14 to 312 days (mean 70.9 days). CSF infection was observed in 5 patients (7.9%). Shunt dependency was observed in 51 out of 58 surviving patients, while 7 cases remained shunt-free at the last follow-up. Multiloculated hydrocephalus was observed in 14 cases. Among these, only one patient initially received NEL and was complicated by isolated trapped temporal horn.

Conclusions: VSgS and NEL are two effective treatment options in the management of PHH. Both procedures should be part of the neurosurgical armamentarium to deal with PHH, since they offer specific advantages in selected patients. A treatment algorithm combining these two options may reduce the infectious risk and the risk of multiloculated hydrocephalus.
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http://dx.doi.org/10.1007/s00381-021-05216-6DOI Listing
May 2021

Letter to the Editor concerning the manuscript: Lung recruitment prior to IN-SUR-E procedure-Safe and effective?

Authors:
Giovanni Vento

Acta Paediatr 2021 08 24;110(8):2473-2474. Epub 2021 May 24.

Dipartimento Universitario Scienze della Vita e Sanità Pubblica, Unità Operativa Complessa di Neonatologia, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

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http://dx.doi.org/10.1111/apa.15910DOI Listing
August 2021

Securement of central venous catheters by subcutaneously anchored suturless devices in neonates.

J Matern Fetal Neonatal Med 2021 May 9:1-4. Epub 2021 May 9.

Department of Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy.

Background: Accidental dislodgement of central venous catheters is a frequent complication in NICU and it often requires catheter replacement. Subcutaneously anchored sutureless devices (SAS) have been recently introduced in clinical practice for securement of different types of central catheters, but they have never been used in neonates. We evaluated safety and efficacy of SAS in neonates.

Methods: All neonates who required central venous catheters inserted ultrasound-guided cannulation during 12 months of clinical practice in our NICU. We adopted SAS for securement of all central venous catheters inserted in neonates ultrasound guided cannulation either of the brachio-cephalic vein (centrally inserted central catheters: CICC) or the femoral vein (femorally inserted central catheters: FICC). Results: seventy-two central catheters were inserted in 70 preterm and term neonates (3-4 Fr power injectable polyurethane catheters; 62 CICC + 10 FICC) and they were all secured with SAS. Mean postmenstrual age at the time of insertion was 31 weeks and mean weight was 1400 g. SAS was easy to place in all cases. The median duration of the line was 6 weeks. No accidental dislodgement of CICC or FICC was recorded. All SAS but one were left in place until elective removal of the catheter. In all patients, SAS removal was easy and uneventful, and it did not require any sedation or local anesthesia. Conclusions: SAS was effective in preventing accidental catheter dislodgement in 100% of cases. Complications during insertion, maintenance and removal were negligible.
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http://dx.doi.org/10.1080/14767058.2021.1922377DOI Listing
May 2021

Continuous glucose monitoring in the neonatal intensive care unit: need for practical guidelines.

Lancet Child Adolesc Health 2021 05;5(5):e15

Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Rome 00168, Italy.

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http://dx.doi.org/10.1016/S2352-4642(21)00096-1DOI Listing
May 2021

Oxidative and Proteolytic Inactivation of Alpha-1 Antitrypsin in Bronchopulmonary Dysplasia Pathogenesis: A Top-Down Proteomic Bronchoalveolar Lavage Fluid Analysis.

Front Pediatr 2021 23;9:597415. Epub 2021 Mar 23.

Dipartimento di Scienze della Vita e Sanità Pubblica, Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

The study investigates the role of the oxidative and proteolytic inactivation of alpha-1 antitrypsin (AAT) in the pathogenesis of bronchopulmonary dysplasia (BPD) in premature infants. Bronchoalveolar lavage fluid (BALF) samples were collected on the 3rd day of life from mechanically ventilated neonates with gestational age ≤ 30 weeks and analyzed without previous treatment (top-down proteomics) by reverse-phase high-performance liquid chromatography-electrospray ionization mass spectrometry. AAT fragments were identified by high-resolution LTQ Orbitrap XL experiments and the relative abundances determined by considering the extracted ion current (XIC) peak area. Forty preterm neonates were studied: 20 (50%) did not develop BPD (no-BPD group), 17 (42.5%) developed mild or moderate new-BPD (mild + moderate BPD group), and 3 (7.5%) developed severe new-BPD (severe BPD group). Eighteen fragments of AAT and a fragment of AAT oxidized at a methionine residue were identified: significantly higher values of AAT fragments 25-57, 375-418, 397-418, 144-171, and 397-418 with oxidized methionine were found in the severe BPD group. The significantly higher levels of several AAT fragments and of the fragment 397-418, oxidized in BALF of preterm infants developing BPD, underlie the central role of an imbalance between proteases and protease inhibitors in exacerbating lung injury and inducing most severe forms of BPD. The study has some limitations, and between them, the small sample size implies the need for further confirmation by larger studies.
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http://dx.doi.org/10.3389/fped.2021.597415DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021761PMC
March 2021

Use of cyanoacrylate glue for the sutureless securement of epicutaneo-caval catheters in neonates.

J Vasc Access 2021 Apr 8:11297298211008103. Epub 2021 Apr 8.

Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Introduction: Epicutaneo-caval catheters (ECC) are pivotal for drug and fluid infusion in neonates. Given the intrinsic importance of the catheter for the patients' health and the need to avoid stressful and painful procedures on premature or critically ill newborns with fragile and poor vein asset, it is clearly necessary an accurate bundle for ECC insertion and management to avoid complications that may lead to non-elective ECC removal. Among others, dislodgment is an acknowledged complication, and conventionally adopted fixing devices seem alone unsatisfying in relation to ECC securement.

Object: To evaluate the usefulness of medical Cyanoacrylate Glue (CG) as a solution to strengthen conventional ECC securement.

Methods: Since the use of CG has become part of our ECC insertion bundle in 2018, the present study compares all term and preterm neonates admitted in our NICU in 2018 who required an ECC for any cause (92 cases) with an historical cohort formed by all neonates who required an ECC in 2017 (80 patients).

Results: CG added to usual securement devices is effective in reducing ECC accidental dislodgment. Moreover, it is easy and safe to apply and remove, limits bleeding and oozing at the puncture site, and may also be an effective antimicrobial mechanical barrier.
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http://dx.doi.org/10.1177/11297298211008103DOI Listing
April 2021

Real-time ultrasound for tip location of umbilical venous catheter in neonates: a pre/post intervention study.

Ital J Pediatr 2021 Mar 18;47(1):68. Epub 2021 Mar 18.

Neonatal Intensive Care Unit, Infermi Hospital, Rimini, AUSL of Romagna, Italy.

Background: Recent guidelines advocate the use of real-time ultrasound to locate umbilical venous catheter tip. So far, training programs are not well established.

Methods: A pre/post interventional study was carried out in our tertiary neonatal intensive care unit centre to evaluate the efficacy of a training protocol in the use of real-time ultrasound. Primary outcome was the percentage in the use of real-time ultrasound.

Results: Fifty-four patients were enrolled. The use of real-time ultrasound for tip location significantly increased after the training program (15.3% vs 89.2%, p <  0.0001). After the training the tip of the catheters was more frequently placed at the junction of the inferior vena cava and right atrium (75% vs 30.7%, p = 0.0023). Twenty-two catheters were also evaluated with serial scans during the intervention phase to assess migration rate which was 50%.

Conclusion: a multimodal, targeted training on the use of real-time ultrasound for umbilical venous catheter placement is feasible. Real-time ultrasound is easily teachable, increases the number of umbilical venous catheters placed in a correct position, reduces the number of line manipulations and the need of chest-x-rays.
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http://dx.doi.org/10.1186/s13052-021-01014-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7977571PMC
March 2021

Incidence and risk factors of retinopathy of prematurity in an Italian cohort of preterm infants.

Ital J Pediatr 2021 Mar 12;47(1):64. Epub 2021 Mar 12.

Division of Neonatology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Catholic University of Sacred Heart, Rome, Italy.

Objective: Non-negligible differences in retinopathy of prematurity (ROP) and its risk factors between different neonatal intensive care units (NICUs) are reported. Our aim was to assess the incidence and risk factors for ROP development in a large cohort of very preterm infants who were assisted in two Italian NICUs.

Methods: Preterm infants with gestational age between 23 and 29 weeks were stratified into subgroups of infants who developed ROP and those who did not; their clinical characteristics were compared with univariate and multivariable logistic regression analyses.

Results: We studied a total of 178 infants of whom 67 (38%) developed ROP (stage 1: n = 12; stage 2: n = 41; stage 3: n = 14). Regression analysis demonstrated that maternal milk (OR 0.979, 95% Cl 0.961-0.998) decreased the risk of developing ROP, while intraventricular hemorrhage (IVH) (OR 2.055, 95% Cl 1.120-3.772) increased it. Moreover, maternal milk was found to decrease (OR 0.981, 95% Cl 0.964-0.997) the risk of ROP at discharge, while RBC transfusion increased it (OR 1.522, 95% Cl 1.208-1.916).

Conclusions: In our cohort the occurrence of ROP was similar to that previously reported. Strategies for promoting the use of mother's own milk, preventing IVH, and standardizing the approach to RBC transfusions could contribute to decreasing the risk of ROP in very preterm infants.
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http://dx.doi.org/10.1186/s13052-021-01011-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953747PMC
March 2021

Lung Ultrasound Score Progress in Neonatal Respiratory Distress Syndrome.

Pediatrics 2021 04 9;147(4). Epub 2021 Mar 9.

NICU, Vittore Buzzi Children's Hospital, Milan, Italy.

Background And Objectives: The utility of a lung ultrasound score (LUS) has been described in the early phases of neonatal respiratory distress syndrome (RDS). We investigated lung ultrasound as a tool to monitor respiratory status in preterm neonates throughout the course of RDS.

Methods: Preterm neonates, stratified in 3 gestational age cohorts (25-27, 28-30, and 31-33 weeks), underwent lung ultrasound at weekly intervals from birth. Clinical data, respiratory support variables, and major complications (sepsis, patent ductus arteriosus, pneumothorax, and persistent pulmonary hypertension of the neonate) were also recorded.

Results: We enrolled 240 infants in total. The 3 gestational age intervals had significantly different LUS patterns. There was a significant correlation between LUS and the ratio of oxygen saturation to inspired oxygen throughout the admission, increasing with gestational age (b = -0.002 [ < .001] at 25-27 weeks; b = -0.006 [ < .001] at 28-30 weeks; b = -0.012 [ < .001] at 31-33 weeks). Infants with complications had a higher LUS already at birth (12 interquartile range 13-8 vs 8 interquartile range 12-4 control group; = .001). In infants 25 to 30 weeks' gestation, the LUS at 7 days of life predicted bronchopulmonary dysplasia with an area under the curve of 0.82 (95% confidence interval 0.71 to 93).

Conclusions: In preterm neonates affected by RDS, the LUS trajectory is gestational age dependent, significantly correlates with the oxygenation status, and predicts bronchopulmonary dysplasia. In this population, LUS is a useful, bedside, noninvasive tool to monitor the respiratory status.
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http://dx.doi.org/10.1542/peds.2020-030528DOI Listing
April 2021

Contactless: a new personalised telehealth model in chronic pediatric diseases and disability during the COVID-19 era.

Ital J Pediatr 2021 Feb 12;47(1):29. Epub 2021 Feb 12.

Pediatric Neurology Unit, Fondazione Policlinico A Gemelli -IRCCS, Università Cattolica del Sacro Cuore, Largo Gemelli 8, 00168, Rome, Italy.

Background: Suspending ordinary care activities during the COVID-19 pandemic made it necessary to find alternative routes to comply with care recommendations not only for acute health needs but also for patients requiring follow-up and multidisciplinary visits. We present the 'Contactless' model, a comprehensive operational tool including a plurality of services delivered remotely, structured according to a complexity gradient, aimed to cover diagnostic procedures and monitor disease progression in chronic pediatric patients.

Methods: A multidisciplinary and multiprofessional project team was recruited, in collaboration with patients' associations, to map a panel of available Evidence-Based solutions and address individual needs in full respect of the concept of personalized medicine. The solutions include a number of services from videoconsultations to more structure videotraining sessions.

Results: A modular framework made up of four three Macro-levels of complexity - Contactless Basic, Intermediate and Advanced - was displayed as an incremental set of services and operational planning establishing each phase, from factors influencing eligibility to the delivery of the most accurate and complex levels of care.

Conclusion: The multimodal, multidisciplinary 'Contactless' model allowed the inclusion of all Units of our Pediatric Department and families with children with disability or complex chronic conditions. The strengths of this project rely on its replicability outside of pediatrics and in the limited resources needed to practically impact patients, caregivers and professionals involved in the process of care. Its implementation in the future may contribute to reduce the duration of hospital admissions, money and parental absence from work.
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http://dx.doi.org/10.1186/s13052-021-00975-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880513PMC
February 2021

Caution advised regarding lung recruitment before surfactant - Authors' reply.

Authors:
Giovanni Vento

Lancet Respir Med 2021 02;9(2):e12

Dipartimento Universitario Scienze della Vita e Sanità Pubblica, Unità Operativa Complessa di Neonatologia, Fondazione Policlinico Universitario A Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Rome 00168, Italy. Electronic address:

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http://dx.doi.org/10.1016/S2213-2600(21)00037-0DOI Listing
February 2021

Time to Positivity of Blood Cultures Could Inform Decisions on Antibiotics Administration in Neonatal Early-Onset Sepsis.

Antibiotics (Basel) 2021 Jan 28;10(2). Epub 2021 Jan 28.

Neonatology Unit, Department of Woman and Child Health and Public Health-Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, 00168 Rome, Italy.

(1) Background: Empirical antibiotics for suspected neonatal early-onset sepsis are often prolonged administered, even in the absence of clinical signs of infection, while awaiting the blood cultures results. The C-reactive protein is widely used to guide antibiotic therapy, although its increase in the first hours of life is not always evidence of infection. The aim of this study was to evaluate the time to positivity (TTP) of blood cultures (BC) that develop pathogens in our population of neonates and determine whether TTP could safely inform the decisions on empirical antibiotic discontinuation in neonatal early-onset sepsis and reduce the use of unnecessary antibiotics. (2) Methods: We retrospectively collected data of all newborns ≥ 34 weeks admitted to the Neonatal Intermediate-Care Unit at Policlinico "A. Gemelli" University Hospital (Rome, Italy) from 2014 to 2018, with suspected early-onset sepsis (EOS). The TTP was the time in hours from the first BC inoculation to the bacterial growth. We defined as positive BC only those with a pathogenic organism. (3) Results: In total, 103 out of 20,528 infants born in the five-year study period were admitted to our Neonatal Intermediate-Care Unit because of a suspected EOS and enrolled into the study. The mean TTP of pathogenic organisms was 17.7 ± 12.5 h versus 80.5 ± 55.8 h of contaminants ( 0.00). We found ten positive BCs. The TTP of BC was lower than 12, 36, and 48 h in 80%, 90%, and 100% of cases, respectively. CRP levels on admission were similar in infants with a positive and negative BC ( = 0.067). The discontinuation of therapy in asymptomatic infants 48 h after initiation would have resulted in a saving of 217 days of antibiotics (31.1% of total days administered). (4) Conclusion: From our data, the TTP of blood cultures that develop pathogens is less than 48 h in 100% of cases. Therefore, in late preterm and full-term infants with suspected EOS, stopping empiric antibiotics 48 h after initiation may be a safe practice to reduce unnecessary antibiotic use, when blood cultures are negative and infants asymptomatic.
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http://dx.doi.org/10.3390/antibiotics10020123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910918PMC
January 2021

Hammersmith Infant Neurological Examination for infants born preterm: predicting outcomes other than cerebral palsy.

Dev Med Child Neurol 2021 08 18;63(8):939-946. Epub 2020 Dec 18.

Pediatric Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Aim: We explored the ability of the Hammersmith Infant Neurological Examination (HINE) to identify typical and delayed cognitive performance in a large population of infants born preterm, both with and without cerebral palsy (CP).

Method: We conducted a retrospective study of infants born preterm who had repeated HINEs between 3 and 12 months corrected age. At 2 years, cognition was assessed using the Mental Development Index (MDI; from the Bayley Scales of Infant Development, Second Edition) and the presence and severity of CP was determined. All children were classified as cognitively typical/mildly delayed or significantly delayed (MDI <70) and CP. The predictive validity of HINE scores for significantly delayed cognitive performance, in children with and without CP, was calculated using specific cut-off scores according to age at assessment.

Results: Of 1229 eligible infants (gestational age 25-36wks, mean [SD] 34.9 [2.3]; 646 males, 583 females), 1108 did not develop CP, 891 had an MDI that was typical/mildly delayed, and 217 had an MDI less than 70. Of the 121 infants who developed CP, the MDI was typical in 28, mildly delayed in 27, and less than 70 in 66. HINE scores showed a good sensitivity and specificity, especially after 3 months, for detecting significantly delayed cognitive performance in infants without CP. In those who developed CP, the score was associated with their cognitive level.

Interpretation: The HINE provides information about the risk of delayed cognitive performance in infants born preterm with and without CP. What this paper adds The Hammersmith Infant Neurological Examination (HINE) can be used in the first year to identify infants born preterm at risk for delayed cognitive performance. Age-dependent HINE cut-off scores are proposed for detecting increased risk of delayed cognitive performance.
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http://dx.doi.org/10.1111/dmcn.14768DOI Listing
August 2021

Infantile Liver Failure Syndrome 1 associated with a novel variant of the LARS1 gene: Clinical, genetic, and functional characterization.

Clin Genet 2021 04 13;99(4):601-603. Epub 2020 Dec 13.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento Universitario Scienze della Vita e Sanità Pubblica, Sezione di Medicina Genomica, Università Cattolica del Sacro Cuore, Rome, Italy.

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http://dx.doi.org/10.1111/cge.13893DOI Listing
April 2021

Thresholds for Neonatal Hypoglycemia in Clinical Settings.

JAMA Pediatr 2021 Mar;175(3):322-323

Department of Woman and Child Health and Public Health, Child Health Area, Università Cattolica del Sacro Cuore, Roma, Italia.

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http://dx.doi.org/10.1001/jamapediatrics.2020.5083DOI Listing
March 2021

Expanding the spectrum of congenital myopathies: prenatal onset with extreme hyperextension of the neck.

Neurol Sci 2021 Apr 26;42(4):1549-1553. Epub 2020 Nov 26.

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

We describe the case of a male newborn presenting with a prenatal diagnosis of persistent hyperextension of the fetal neck and severe hypotonia and respiratory insufficiency at birth. Facial weakness, increased serum creatine kinase levels, and abnormal feeding, together with other signs, such as severe contractures, also classically associated with congenital myopathies prompted to perform a muscle biopsy showing internal rods suggestive of a possible nemaline myopathy. These findings suggest that a careful neurological examination should be performed in infants with persistent hyperextension of the fetal neck to exclude weakness and a possible underlying muscle disorder.
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http://dx.doi.org/10.1007/s10072-020-04937-xDOI Listing
April 2021

Neurodevelopmental outcomes in very preterm infants: The role of severity of Bronchopulmonary Dysplasia.

Early Hum Dev 2021 01 16;152:105275. Epub 2020 Nov 16.

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.

Objective: Bronchopulmonary dysplasia is a chronic respiratory disease that still affects preterm neonates; its association with neurodevelopmental (ND) impairment is already known. Different studies investigated neurodevelopmental outcomes in infants with BPD, often using the old dichotomous definition (BPD vs Non-BPD). This retrospective study aims to evaluate the role of different BPD severity grades on ND outcomes at 24 months of corrected age (CA).

Methods: All preterm infants born between 2011 and 2015 in the study hospital with a gestational age (GA) ≤ 30 weeks and discharged from our NICU were included and were divided in infants with and without BPD. Infants with BPD were divided into three severity groups as defined by NICHD/NHLBI Workshop in 2001, and were compared to their Non-BPD peers, matching them according to the same GA and year of birth. At 24 months postmenstrual age, we assessed general outcomes (growth and hospital readmissions) and neurodevelopmental outcomes (motor, developmental and sensory outcomes) with a standardized assessment.

Results: We enrolled 89 patients affected by BPD of different grades of severity and a control group of 89 preterm infants without BPD. Infants with Moderate and Severe BPD showed a significantly higher corrected odds ratio (OR) for cognitive impairment compared to controls. Within the group of infants without severe disability (regarding Griffiths' scales), infants with Moderate and Severe BPD as well as infants with Mild BPD showed a significantly higher risk of a lower total Developmental Quotient (DQ) score, even after correction for confounding factors.

Conclusions: Our study evidenced that not only Severe BPD infants, but also Moderate ones showed a higher risk of overall cognitive impairment at 24 months CA. Within the group of infants without severe disability, also those with Mild BPD had lower Griffiths DQ scores than those without. This would suggest that infants with BPD, regardless of severity, warrant neurodevelopmental follow-up.
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http://dx.doi.org/10.1016/j.earlhumdev.2020.105275DOI Listing
January 2021

Growth of Head Circumference and Body Length in Preterm Infants Receiving a Multicomponent vs a Soybean-Based Lipid Emulsion: A Randomized Controlled Trial.

JPEN J Parenter Enteral Nutr 2021 01 10;45(1):94-101. Epub 2020 Aug 10.

Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.

Background: The growth of very low-birth-weight (VLBW) infants relies, to a large extent, on parenteral nutrition (PN) during the early weeks of life. Despite the parenteral nutrients supply, extrauterine growth restriction remains the main concern for these infants. A parenteral multicomponent lipid emulsion (MLE) might improve growth and neurological outcomes, delivering fats for brain growth that the traditional soybean-based lipid emulsion (SLE) fails to provide. We hypothesize that the use of an MLE in PN may reduce the loss of head circumference (HC) z-score from birth to 36 weeks' postmenstrual age (PMA) or at discharge compared with the use of an SLE in VLBW infants.

Methods: Infants with BW ≤1250 g, without malformations or chromosomal abnormalities, were randomly assigned to receive an MLE or an SLE. The primary outcome was the change in HC z-score (HC Δ z-score) from birth to 36 weeks' PMA or at discharge. Secondary outcomes included the change in weight and length z-score (W Δ z-score and L Δ z-score) as well as incidence of late-onset sepsis and PN-associated cholestasis (PNAC).

Results: Of the 128 infants randomized, 51 infants in the MLE group and 50 infants in the SLE group were analyzed. The MLE was significantly associated with a decreased loss in HC and length z-scores from birth to 36 weeks' PMA or at discharge.

Conclusions: This is the first randomized controlled trial providing the evidence that an MLE is associated with improved HC growth in comparison with a pure SLE.
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http://dx.doi.org/10.1002/jpen.1968DOI Listing
January 2021

Response to therapy among neonates with gastro-esophageal reflux is associated with esophageal clearance.

Early Hum Dev 2021 01 10;152:105248. Epub 2020 Nov 10.

Neonatal Unit, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Largo A. Gemelli 8, 00168 Rome, Italy.

Background: Few studies evaluated the efficacy of pharmacological therapy for gastro-esophageal reflux disease (GERD) in newborns, whose safety has been questioned. Esophageal basal impedance (BI) is a marker of mucosal integrity, and treatment with proton pump inhibitors significantly increases BI in infants; however, no correlation with clinical improvement was reported.

Aims: To evaluate the relationship between BI and other esophageal pH-impedance parameters and clinical response to therapy in newborns with GERD.

Study Design: Multicenter retrospective study.

Subjects: Infants who received omeprazole or ranitidine for GERD.

Outcome Measures: Complete response to therapy was defined as symptom decrease by ≥50% compared to baseline, partial response as symptom decrease <50%, no response as no symptom decrease based on chart analysis. Response to therapy was assessed 2 and 4 weeks after the onset of therapy. Univariate and multivariate statistics were performed to assess associations between response to therapy and clinical/pH-impedance parameters.

Results: We studied 60 infants (51 born preterm): 47 received omeprazole, 13 ranitidine. Response to therapy was associated with decreasing esophageal clearance time: odds ratio 0.308, 95%CI 0.126-0.753, p = 0.010 at 2 weeks, odds ratio 0.461, 95%CI 0.223-0.955, p = 0.037 at 4 weeks.

Conclusions: Clinical response to therapy among infants with GERD was associated with esophageal clearance but not with esophageal BI level.
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http://dx.doi.org/10.1016/j.earlhumdev.2020.105248DOI Listing
January 2021

HPLC-ESI-MS top-down analysis of salivary peptides of preterm newborns evidenced high activity of some exopeptidases and convertases during late fetal development.

Talanta 2021 Jan 25;222:121429. Epub 2020 Aug 25.

Laboratorio di Proteomica, Centro Europeo di Ricerca Sul Cervello, IRCCS Fondazione Santa Lucia, Roma, Italy. Electronic address:

To have information on the proteolytic activity of convertases and exo-peptidases on human salivary proteins, this study investigated the relative amounts of the truncated proteoforms in the saliva of preterm newborns and compared them with the relative amounts measured in saliva of at-term newborns, of babies (0-10 years old) and of adults. Results indicated that convertase(s), acting on acidic proline-rich proteins and histatin 3, and carboxypeptidase(s) acting on acidic proline-rich proteins, P-C peptide, histatin 6 and statherin were many folds more active in preterm newborns than in the other groups. Conversely, the aminopeptidase responsible for the removal of the N-terminal Asp residue of statherin was not active in preterm newborns, becoming active only several months after the normal term of delivery. The high activity of convertases determined in preterm newborns suggests that it is required for the molecular events connected to the fetus development, and encourages further studies devoted to the characterization of their specific substrates.
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http://dx.doi.org/10.1016/j.talanta.2020.121429DOI Listing
January 2021

Nusinersen in type 0 spinal muscular atrophy: should we treat?

Ann Clin Transl Neurol 2020 12 4;7(12):2481-2483. Epub 2020 Nov 4.

Pediatric Neurology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.

A male infant affected by type 0 SMA with one copy of SMN2 received early treatment with Nusinersen at the age of 13 days. He showed mild motor improvement 2 months after treatment started but despite also showing some minimal respiratory improvement, required tracheostomy at the age of 4 months and had increasing cardiac and autonomic dysfunction leading to exitus at 5 months. Our findings, expanding the results available on Nusinersen, confirm its relative efficacy in the most severely affected infants and provide clinical evidence to be used at the time requests for treating severe infants are discussed.
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http://dx.doi.org/10.1002/acn3.51126DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732235PMC
December 2020

Effect of Different Milk Diet on the Level of Fecal Calprotectin in Very Preterm Infants.

Front Pediatr 2020 16;8:552. Epub 2020 Sep 16.

Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

To evaluate the course of fecal calprotectin (FC) in very preterm infants over the first 15 days of life in relation to the type of milk diet. This study was part of a randomized controlled trial comparing two different ways of integrating the own mother's milk (OMM) for the evaluation of feeding tolerance in very preterm infants. In infants with gestational age of ≤ 32 weeks randomized to receive preterm formula (PF group) or pasteurized donor human milk (PDHM group) as a supplement to the OMM insufficient or unavailable, FC level was planned to be measured at the first meconium passage and at days 8 and 15 of life (T0, T1, and T2, respectively). FC data were available for all the 70 infants randomized, 35 in the PF group, and 35 in the PDHM group. The mean FC levels were similar in the two study groups at T0 and T1, whereas they were significantly higher in the PF group than the PDHM group at T2. FC values decreased over the first week of life in both groups and significantly increased over the second week of life only in the PF group. Our study demonstrates a significant increase in FC levels when PF is used as a supplement to the OMM compared to the use of PDHM. Further studies are needed to establish if the higher FC levels in infants receiving PF are the expression of a normal immunological maturation rather than an initial inflammatory process.
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http://dx.doi.org/10.3389/fped.2020.00552DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524876PMC
September 2020

Infectious complications in neonatal transfusion: Narrative review and personal contribution.

Transfus Apher Sci 2020 Oct 16;59(5):102951. Epub 2020 Sep 16.

Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; Sezione di Ematologia, Dipartimento di Scienze Radiologiche ed Ematologiche, Università Cattolica del Sacro Cuore, Roma, Italy. Electronic address:

Neonates and prematures are among the most transfused categories of patients. Adverse reactions due to transfusions, such as transfusion-transmitted infections, can affect the rest of their lives. In this systematic review, we revised the literature concerning transfusion-transmitted infection in neonates. We reported case-reports and case-series previously published and we integrated these data with our experience at local neonatal intensive care unit. Moreover, we illustrated strategies for mitigating transfusion-transmitted infections, including donor selection and testing, pathogen inactivation technologies and combined approaches, as for Cytomegalovirus infection, integrating leukoreduction and identification of seronegative donors.
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http://dx.doi.org/10.1016/j.transci.2020.102951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492833PMC
October 2020
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