Publications by authors named "Montaldo P"

Objective: To evaluate the accuracy of a device for continuous glucose monitoring (CGM) among infants born preterm admitted to the neonatal intensive care unit.

Study Design: We analyzed paired CGM sensor glucose (SG) and point-of-care blood glucose (BG) measurements collected in infants born at ≤32 weeks of gestation or with a birth weight ≤1500 g. CGM was initiated within 48 hours from birth and maintained for 5 days.

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Article Synopsis
  • The COMET trial aims to determine if whole-body hypothermia can improve cognitive development in neonates with mild hypoxic ischemic encephalopathy, a condition linked to learning difficulties.
  • It is a phase III multicenter randomized controlled trial involving 426 neonates, comparing hypothermia treatment (33.5°C) to normothermia (37.0°C) within the first six hours of birth.
  • The primary goal is to evaluate cognitive outcomes at two years using the Bayley scales, while also ensuring the trial's safety and assessing healthcare resource utilization.
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Background: Although levetiracetam and phenytoin are widely used antiseizure medications (ASM) in neonates, their efficacy on seizure freedom is unclear. We evaluated electroencephalographic (EEG) seizure freedom following sequential levetiracetam and phenytoin in neonatal seizures unresponsive to phenobarbital.

Methods: We recruited neonates born ≥35 weeks and aged <72 h who had continued electrographic seizures despite phenobarbital, from three Indian hospitals, between 20 June 2020 and 31 July 2022.

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Since January 2024, Italy experiences a pertussis outbreak, primarily affecting neonates and unvaccinated infants at high risk of severe complications and mortality; 11 major paediatric centres noted 108 hospitalisations and three deaths by 10 May. The outbreak reflects increased circulation of and non-adherence to immunisation recommendations during pregnancy. Public health interventions, including maternal immunisation, vaccination of infants as early as possible and post-exposure prophylaxis, are critical for reducing the burden of pertussis and preventing further mortality.

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Objective: To examine the feasibility of early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy (HIE).

Design: Double-blind pilot randomised controlled trial.

Setting: Eight neonatal units in South Asia.

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Article Synopsis
  • This study investigates the safety and effectiveness of whole-body hypothermia in neonates who have experienced mild hypoxic-ischemic encephalopathy (HIE), as existing data mainly focuses on cases of more severe illness.* -
  • Conducted as a randomized clinical trial across six neonatal intensive care units in the UK and Italy, 101 eligible neonates were assigned to either normothermia or different durations of hypothermia (48 or 72 hours) based on their age after birth.* -
  • The study primarily measures the concentration of thalamic N-acetyl aspartate through MRI to assess the impact of hypothermia on brain health, revealing specific outcomes in the treatment groups.*
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Acute kidney injury (AKI) refers to a swift decline in kidney function, marked by the reduced excretion of waste products and disturbances in fluid and electrolyte balance [...

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  • Induced hypothermia, a common treatment for hypoxic-ischemic encephalopathy (HIE), is less effective in South Asia despite the region having a high disease burden compared to high-income countries.
  • This study aimed to compare blood genome expression profiles of neonates with HIE from high-income countries (Italy) and low-income countries (India, Sri Lanka, and Bangladesh) to understand differences in outcomes.
  • The findings revealed variations in blood expression profiles at birth linked to adverse outcomes and highlighted differing responses to treatment in the two cohorts of neonates.
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Background: Effect of duration of birth depression on neurodevelopmental outcomes in low- and middle-income countries (LMICs) is not known. We examined the association of birth depression with brain injury, neurodevelopmental outcomes, and hypothermia after hypoxic ischemic encephalopathy (HIE) in south Asia.

Methods: We compared cerebral magnetic resonance (MR) at 2 weeks, and adverse outcomes (death or moderate or severe disability) at 18 months in 408 babies with moderate or severe HIE who had long birth depression (positive pressure ventilation (PPV) >10 min or Apgar score<6 at 10 min or cord pH < 7.

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Objectives: The primary outcomes of this study were to evaluate the diameters of the inferior vena cava (IVC) in a cohort of newborns and the correlation between newborn weight and IVC diameter. The secondary outcome was to evaluate the concordance between the measurements performed by the two investigators.

Methods: Two blind examiners performed an ultrasonographic (US) evaluation of the IVC diameter in neonates with a weight ranging from 2 to 4 kg.

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Importance: Although hypoglycaemia and hyperglycaemia represent the most common metabolic problem in neonates, there is still uncertainty regarding the effects of glucose homoeostasis on the neurological outcomes of infants with neonatal encephalopathy (NE).

Objective: To systematically investigate the association between neonatal hypoglycaemia and hyperglycaemia with adverse outcome in children who suffered from NE.

Study Selection: We searched Pubmed, Embase and Web of Science databases to identify studies which reported prespecified outcomes and compared infants with NE who had been exposed to neonatal hypoglycaemia or hyperglycaemia with infants not exposed.

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Article Synopsis
  • The study investigates the relationship between the place of birth (inborn vs. outborn) and the effectiveness of whole-body hypothermia in protecting against brain injury in neonates suffering from hypoxic-ischemic encephalopathy (HIE) in low- and middle-income countries.
  • Conducted in seven neonatal intensive care units across India, Sri Lanka, and Bangladesh, the research followed 408 neonates born after 36 weeks of gestation who were randomized into hypothermia and control groups, tracking various brain injury indicators over time.
  • Results indicate that inborn neonates were generally smaller and had different delivery methods compared to outborn neonates, raising questions about how birthplace impacts treatment outcomes for HIE in this demographic
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Background: There is increasing concern that infants with mild hypoxic-ischaemic encephalopathy (HIE) may develop seizures and progress to moderate HIE beyond the therapeutic window for cooling.

Objective: The aim of this study was to examine the effect of therapeutic hypothermia on magnetic resonance imaging (MRI) biomarkers and neurological outcomes in infants with mild HIE and seizures within 24 h after birth.

Methods: This study shows an observational cohort study on 366 (near)-term infants with mild HIE and normal amplitude-integrated electroencephalography background.

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Background: The prevalence of certain multidrug-resistant organisms (MDROs), especially Gram-negative bacteria, is dramatically increasing in patient care settings, including pediatric and neonatal units. However, most of the new drugs available for the treatment of MDROs have not yet been studied in children and newborns.

Case Report: We report the clinical case of a preterm neonate, born at 31 weeks gestation + 1 day of age by emergency Cesarean Section (CS), with a bloodstream infection (BSI) due to a Verona integron-borne metallo-β-lactamase (VIM)-producing Klebsiella pneumoniae.

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  • - The ocular microbiome plays a crucial role in maintaining eye health, and its disruption can affect eye functionality.
  • - A study collected conjunctival swabs from newborns before and after antibiotic treatment to analyze changes in microbiota composition through 16S rRNA sequencing.
  • - Results showed that gentamicin antibiotic treatment significantly reduced certain bacterial groups while increasing others, highlighting the need to understand these changes to prevent potential negative effects on eye health.
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Intrauterine growth restriction (IUGR) is associated with a higher incidence of perinatal complications as well as cardiovascular and renal diseases later on. A better insight into the disease mechanisms underlying these sequalae is important in order to identify which IUGR infants are at a higher risk and find strategies to improve their outcome. In this prospective case-control study we examined whether IUGR had any effect on renal and cerebral perfusion and oxygen saturation in term neonates.

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We hypothesized that the heart rate (HR) variation in an acute setting compared with HR in wellbeing status could be a good marker of both dehydration and acute kidney injury (AKI). Since HR in wellbeing status is unknown in most cases, we assumed as reliable surrogate the 50th percentile of HR according to age and gender. We evaluated if the estimated percentage of heart rate variation in acute setting compared with 50th percentile of HR (EHRV) could be marker of dehydration and AKI in children.

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Background: Oxytocin is widely used for induction and augmentation of labour, particularly in low- and middle-income countries (LMICs). In this systematic review and meta-analysis, we examined the effect of intra-partum Oxytocin use on neonatal encephalopathy.

Methods: The protocol for this study was registered with PROSPERO (ID: CRD42020165049).

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N-acetylcysteine (NAC) and vitamin D provide effective neuroprotection in animal models of severe or inflammation-sensitized hypoxic ischemic encephalopathy (HIE). To translate these FDA-approved drugs to HIE neonates, we conducted an early phase, open-label trial of 10 days of NAC (25, 40 mg/kg q12h) + 1,25(OH)D (calcitriol 0.05 mg/kg q12h, 0.

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Background: Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia.

Methods: We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh.

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