Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study.

Background: One of the greatest challenges to conducting multicenter research studies in low and middle-income countries (LMICs) is the heterogeneity in regulatory processes across sites. Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research.

Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in LMICs during the IRB process of an international multicenter observational point prevalence study (Global PARITY).

Evaluation of Vancomycin Dose Needed to Achieve 24-Hour Area Under the Concentration-Time Curve to Minimum Inhibitory Concentration Ratio Greater Than or Equal to 400 Using Pharmacometric Approaches in Pediatric Intensive Care Patients.

Objectives: To investigate which independent factor(s) have an impact on the pharmacokinetics of vancomycin in critically ill children, develop an equation to predict the 24-hour area under the concentration-time curve from a trough concentration, and evaluate dosing regimens likely to achieve a 24-hour area under the concentration-time curve to minimum inhibitory concentration ratio (AUC24/MIC) greater than or equal to 400.

Design: Prospective population pharmacokinetic study of vancomycin.

Setting: Critically ill patients in quaternary care PICUs.

A research definition and framework for acute paediatric critical illness across resource-variable settings: a modified Delphi consensus.

The true global burden of paediatric critical illness remains unknown. Studies on children with life-threatening conditions are hindered by the absence of a common definition for acute paediatric critical illness (DEFCRIT) that outlines components and attributes of critical illness and does not depend on local capacity to provide critical care. We present an evidence-informed consensus definition and framework for acute paediatric critical illness.

Capacity Building in Pediatric Critical Care-Global Health Research and Education: The Blantyre Experience.

Pediatric critical care medicine (PCCM), as it is practiced in high-income countries, is focused on specialized medical care for the most vulnerable pediatric patient populations. However, best practices for provision of that care globally are lacking. Thus, PCCM research and education programming can potentially fill significant knowledge gaps by facilitating the development of evidence-based clinical guidelines that reduce child mortality on a global scale.

The Burden of Critical Illness in Hospitalized Children in Low- and Middle-Income Countries: Protocol for a Systematic Review and Meta-Analysis.

Background: The majority of childhood deaths occur in low- and middle-income countries (LMICs). Many of these deaths are avoidable with basic critical care interventions. Quantifying the burden of pediatric critical illness in LMICs is essential for targeting interventions to reduce childhood mortality.

Global PARITY: Study Design for a Multi-Centered, International Point Prevalence Study to Estimate the Burden of Pediatric Acute Critical Illness in Resource-Limited Settings.

Background: The burden of pediatric critical illness and resource utilization by children with critical illness in resource limited settings (RLS) are largely unknown. Without specific data that captures key aspects of critical illness, disease presentation, and resource utilization for pediatric populations in RLS, development of a contextual framework for appropriate, evidence-based interventions to guide allocation of limited but available resources is challenging. We present this methods paper which describes our efforts to determine the prevalence, etiology, hospital outcomes, and resource utilization associated with pediatric acute, critical illness in RLS globally.

Bedside Rounds in Intensive Care Units during the COVID-19 Pandemic and Beyond.

A survey-based pilot study was performed to examine the feasibility of videoconferencing to facilitate multidisciplinary rounds following the initiation of strict isolation and social distancing policies in a pediatric intensive care unit (PICU). The use of a mobile workstation was implemented as the central hub for rounding at the bedside by the attending physicians, while other members of the multidisciplinary and multispecialty team joined rounds from other locations with maintaining appropriate social distance. Fifty-eight staff members who participated in videoconferencing rounds completed the postimplementation survey.

Multisystem inflammatory syndrome (MIS-C) in Pakistani children: A description of the phenotypes and comparison with historical cohorts of children with Kawasaki disease and myocarditis.

Objectives: To determine clinical, laboratory features and outcomes of Multisystem Inflammatory Syndrome in children (MIS-C) and its comparison with historic Kawasaki Disease (KD) and Viral Myocarditis (VM) cohorts.

Methods: All children (1 month- 18 years) who fulfilled the World Health Organization criteria of MIS-C presenting to two tertiary care centers in Karachi from May 2020 till August 31st were included. KD and VM admitted to one of the study centers in the last five years prior to this pandemic, was compared to MIS-C.

Reduction in paediatric intensive care admissions during COVID-19 lockdown in Maryland, USA.

As a public health measure during the COVID-19 pandemic, governments around the world instituted a variety of interventions to 'flatten the curve'. The government of Maryland instituted similar measures. We observed a striking decline in paediatric intensive care unit (PICU) admissions during that period, mostly due to a decease in respiratory infections.

Comparison of Antithrombin III Products in Pediatric Patients Receiving Extracorporeal Membrane Oxygenation.

The study investigated the safety and efficacy of two antithrombin III (ATIII) products in pediatric patients receiving extracorporeal membrane oxygenation (ECMO) by performing a retrospective analysis of patients who received either recombinant ATIII (rATIII) or human-derived ATIII (hATIII). Twenty-two patients were included in the study from January 2014 to September 2015 and all received unfractionated heparin (UFH) as anticoagulation during ECMO. In total, 86 doses of ATIII were included in the analysis in which 37 doses (43%) were rATIII and 49 doses (57%) were hATIII.

School-Age Test Proficiency and Special Education After Congenital Heart Disease Surgery in Infancy.

Objective: To evaluate test proficiency and the receipt of special education services in school-age children who had undergone surgery for congenital heart disease (CHD) at age <1 year.

Study Design: Data from Arkansas-born children who underwent surgery for CHD at Arkansas Children's Hospital at age <1 year between 1996 and 2004 were linked to state birth certificates and the Arkansas Department of Education longitudinal database containing achievement test scores in literacy and mathematics for grades 3-4 and special education codes. The primary negative outcome was not achieving grade-level proficiency on achievement tests.

Amplitude-integrated EEG in newborns with critical congenital heart disease predicts preoperative brain magnetic resonance imaging findings.

Objective: The study aims are to evaluate cerebral background patterns using amplitude-integrated electroencephalography in newborns with critical congenital heart disease, determine if amplitude-integrated electroencephalography is predictive of preoperative brain injury, and assess the incidence of preoperative seizures. We hypothesize that amplitude-integrated electroencephalography will show abnormal background patterns in the early preoperative period in infants with congenital heart disease that have preoperative brain injury on magnetic resonance imaging.

Methods: Twenty-four newborns with congenital heart disease requiring surgery at younger than 30 days of age were prospectively enrolled within the first 3 days of age at a tertiary care pediatric hospital.

Steroid therapy attenuates acute phase reactant response among children on ventricular assist device support.

Background: Hyperfibrinogenemia, which can create a procoagulant milieu, is frequently observed in patients supported with the Berlin EXCOR (Berlin Heart GmbH, Berlin, Germany) ventricular assist device (VAD). We began initiating corticosteroids in patients with systemic inflammatory response syndrome (SIRS) episodes to mitigate hyperfibrinogenemia. We set forth to describe the impact of corticosteroids on the hyperfibrinogenemic state in our institutional experience.

White matter injury in newborns with congenital heart disease: a diffusion tensor imaging study.

Background: Brain injury is observed on cranial magnetic resonance imaging preoperatively in up to 50% of newborns with congenital heart disease. Newer imaging techniques such as diffusion tensor imaging provide sensitive measures of the white matter integrity. The objective of this study was to evaluate the diffusion tensor imaging analysis technique of tract-based spatial statistics in newborns with congenital heart disease.

Discrepancies between autopsy and clinical findings among patients requiring extracorporeal membrane oxygenator support.

Discrepancy between clinical and autopsy diagnosis in children supported on extracorporeal membrane oxygenation (ECMO) has not been previously described. To assess the utility of autopsy examination in children supported on ECMO and assess discrepancies between premortem and postmortem diagnosis in these patients. Retrospective chart review.

Extracorporeal membrane oxygenation support among children with adenovirus infection: a review of the Extracorporeal Life Support Organization registry.

Overwhelming adenovirus infection requiring extracorporeal membrane oxygenation (ECMO) support carries a high mortality in pediatric patients. The objective of this study was to retrospectively review data from the Extracorporeal Life Support Organization (ELSO) registry for pediatric patients with adenovirus infection and define for this patient cohort: 1) clinical characteristics, 2) survival to hospital discharge, and 3) factors associated with mortality before hospital discharge. In this retrospective registry study, pediatric patients with adenovirus infection requiring ECMO support identified in an international ECMO registry from 1998 to 2009 were compared for clinical characteristics (demographics, pre-ECMO variables, and complications on ECMO) between survivors and nonsurvivors to hospital discharge.

Academic proficiency in children after early congenital heart disease surgery.

Children with early surgery for congenital heart disease (CHD) are known to have impaired neurodevelopment; their performance on school-age achievement tests and their need for special education remains largely unexplored. The study aimed to determine predictors of academic achievement at school age and placement in special education services among early CHD surgery survivors. Children with CHD surgery at <1 year of age from January 1, 1998 to December 31, 2003, at the Arkansas Children's Hospital were identified.

Incremental reduction in the incidence of stroke in children supported with the Berlin EXCOR ventricular assist device.

Background: Cerebrovascular events (CVEs) are common among children supported with the Berlin EXCOR (Berlin Heart GmbH, Berlin, Germany) ventricular assist device (VAD). Given the high incidence of CVEs associated with this device, we sought to describe our institutional experience in incrementally reducing CVEs in children supported with the Berlin EXCOR VAD.

Methods: We collected pertinent data on 39 consecutive patients who underwent Berlin EXCOR VAD implantation at a single center.

Comparative effects of ventricular assist device and extracorporeal membrane oxygenation on renal function in pediatric heart failure.

Background: Effects of mechanical cardiac support on renal function in children with end-stage heart failure are unknown. The objective of this study was to investigate the impact of ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) on renal function in children.

Methods: We performed a single center retrospective observational study in children with end-stage heart failure supported on pediatric mechanical cardiac support.

Multi-tiered analysis of brain injury in neonates with congenital heart disease.

Early brain injury occurs in newborns with congenital heart disease (CHD) placing them at risk for impaired neurodevelopmental outcomes. Predictors for preoperative brain injury have not been well described in CHD newborns. This study aimed to analyze, retrospectively, brain magnetic resonance imaging (MRI) in a heterogeneous group of newborns who had CHD surgery during the first month of life using a detailed qualitative CHD MRI Injury Score, quantitative imaging assessments (regional apparent diffusion coefficient [ADC] values and brain volumes), and clinical characteristics.

Short-term outcome of neonates with congenital heart disease and diaphragmatic hernia treated with extracorporeal membrane oxygenation.

Background: Major congenital heart disease (CHD) is seen in 10% to 15% of patients with congenital diaphragmatic hernia (CDH). Some neonates with CDH and major CHD are treated by surgery and some with extracorporeal membrane oxygenation (ECMO). Because of presumed poor survival, there is significant heterogeneity in management approaches for patients with CDH and associated CHD, and there is no published outcome data of patients who were placed on ECMO support.

High-dose argatroban for heparin-induced thrombocytopenia in a child using a ventricular assist device.

A 10-year-old boy who was receiving support from a ventricular assist device (VAD) experienced heparin-induced thrombocytopenia that was successfully treated with high-dose argatroban infusion to attain therapeutic activated partial thromboplastin time in spite of high serum argatroban levels. This case also highlights bolus argatroban dosing for VAD change in the setting of persistent ventricular fibrillation.