The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD): Psychometric validation and meaningful change threshold in patients with idiopathic or diabetic gastroparesis.

Introduction: The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) is a patient-reported outcome (PRO) instrument for gastroparesis. This study evaluated the psychometric properties of the ANMS GCSI-DD and determined a meaningful change threshold using the data from a phase 2b trial in adults with moderate-to-severe idiopathic or diabetic gastroparesis (DG).

Methods: The psychometric properties of ANMS GCSI-DD were analyzed using other clinician- and patient-reported outcomes from 242 patients during the 12-week trial.

Survey of nutrition screening practices in pediatric hospitals across the United States.

Background: Nutrition screening on admission is critically important to systematically identify patients with undernutrition given the known relationship with deleterious clinical outcomes. Limited data exist regarding optimal processes and criteria for pediatric nutrition screening. Therefore, we sought to characterize nutrition screening practices in pediatric hospitals.

Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.

Background: Linaclotide, a guanylate cyclase C agonist, has been approved in the USA for the treatment of chronic idiopathic constipation and irritable bowel syndrome with predominant constipation in adults. We aimed to assess the efficacy and safety of linaclotide in paediatric patients aged 6-17 years with functional constipation.

Methods: This randomised, double-blind, placebo-controlled, multicentre, phase 3 study was done at 64 clinic or hospital sites in seven countries (USA, Canada, Israel, Italy, the Netherlands, Ukraine, and Estonia).

Improving anthropometric measurements in hospitalized children: A quality-improvement project.

Background: The objective of this quality-improvement project was to increase documentation rates of anthropometrics (measured weight, length/height, and body mass index [BMI], which are critical to identify patients at malnutrition (undernutrition) risk) from <50% to 80% within 24 hours of hospital admission for pediatric patients.

Methods: Multidisciplinary champion teams on surgical, cardiac, and intensive care (ICU) pilot units were established to identify and iteratively test interventions addressing barriers to documentation from May 2016 to June 2018. Percentage of patients with documented anthropometrics <24 h of admission was assessed monthly by statistical process control methodology.

Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK-906) for idiopathic or diabetic gastroparesis.

Background: Previous clinical studies of trazpiroben, a dopamine D /D receptor antagonist for long-term treatment of moderate-to-severe idiopathic and diabetic gastroparesis, have shown improved symptoms of fullness. This study assessed trazpiroben efficacy, safety, and tolerability in adults with idiopathic and diabetic gastroparesis versus placebo.

Methods: This global, multicenter, double-blind, parallel-group, phase 2b study (NCT03544229) enrolled eligible adults aged 18-85 years with symptomatic idiopathic or diabetic gastroparesis.

Clinical Presentations of Drug-Induced Hyperprolactinaemia: A Literature Review.

Screening for drug-induced hyperprolactinaemia, a condition characterised by higher-than-normal levels of serum prolactin induced by drug treatments, requires a comprehensive understanding of the clinical presentations and long-term complications of the condition. Using two databases, Embase and MEDLINE, we summarised the available evidence on the clinical presentations and long-term complications of drug-induced hyperprolactinaemia. Clinical and observational studies reporting on drug treatments known or suspected to induce hyperprolactinaemia were included.

Risk of Adverse Events Associated with Domperidone and Metoclopramide in Gastroparesis: Systematic Review and Meta-analysis.

Background: Dopamine antagonists are the main pharmacological options to treat gastroparesis. The aim of this study was to conduct a systematic literature review (SLR) to evaluate the profile of adverse events (AEs) of dopamine antagonists used in the treatment of children and adults with gastroparesis.

Methods: We searched EMBASE and MEDLINE up to March 25, 2021, for relevant clinical trials and observational studies.

Clinical characteristics and MRI-based phenotypes of perianal abscess formation in children with fistulizing Crohn's Disease.

Purpose: The aim of this study was to explore potential correlation of the MR imaging features and clinical characteristics with formation of perianal abscess in children with Crohn's perianal fistulas (CPF).

Methods: From 2010 to 2020, pediatric patients with CPF diagnosis on their first pelvic MRI were identified retrospectively. All patients were divided into two groups based on the presence or absence of perianal abscess.

The pharmacokinetics of oral trazpiroben (TAK-906) after organic anion transporting polypeptide 1B1/1B3 inhibition: A phase I, randomized study.

Trazpiroben is a dopamine D /D receptor antagonist under development for the treatment of gastroparesis. This phase I, open-label, randomized, two-way crossover study (NCT04121078) evaluated the effect of single-dose intravenous rifampin, a potent inhibitor of the organic anion transporting polypeptides (OATPs) 1B1 and 1B3, on the pharmacokinetics and safety of trazpiroben in healthy adults. The utility of coproporphyrin (CP) I and CPIII as biomarkers of OATP inhibition was also assessed.

Health-care resource use and costs associated with diabetic and idiopathic gastroparesis: A claims analysis of the first 3 years following the diagnosis of gastroparesis.

Background: Due to limited treatment options, many patients with diabetic gastroparesis (DG) or idiopathic gastroparesis (IG) experience inadequate symptom control resulting in increased health-care resource utilization (HRU) and associated costs. We compared all-cause HRU and health-care costs over the 3 years after patients' first gastroparesis diagnosis with that of matched controls without gastroparesis.

Methods: Newly diagnosed adults with DG or IG were identified in Optum's de-identified Clinformatics Data Mart Database (Q1-2007 to Q1-2019).

Epidemiology, Etiology, and Treatment of Gastroparesis: Real-World Evidence From a Large US National Claims Database.

Background & Aims: Although gastroparesis carries a considerable health care and patient burden, associated epidemiological data are limited. To provide new real-world evidence for gastroparesis, we estimated disease prevalence, and investigated patient demographics and disease etiology in a large US claims database.

Methods: This retrospective, cross-sectional analysis used de-identified, longitudinal patient-level enrollment and billing data for adults from the Optum Clinformatics Data Mart database, a large US national administrative health insurance claims database.

Delivery by caesarean section and offspring adiposity and cardio-metabolic health at ages 6.5, 11.5 and 16 years: results from the PROBIT cohort in Belarus.

Background: Caesarean delivery has been associated with later adiposity, perhaps via early programming or perhaps because of residual confounding by maternal or birth characteristics.

Objectives: Examine associations of caesarean delivery with adiposity and cardio-metabolic biomarkers.

Methods: Observational analysis of 15 069 children in the PROBIT cohort in Belarus.

Maternal Place of Birth, Socioeconomic Characteristics, and Child Health in US-Born Latinx Children in Boston.

Objective: Among US-born children of Latina US (USB) and Latina foreign-born mothers (FBM), to determine whether 1) household and child characteristics differ; 2) child health outcomes differ; 3) these differences diminish for children of FBM with longer duration of residence in the United States; and 4) these differences can be explained by food insecurity (FI) or by Supplemental Nutrition Assistance Program (SNAP) participation.

Methods: Cross-sectional survey of 2145 Latina mothers of publicly insured US-born children 0 to 48 months old in a Boston emergency department (ED) 2004 to 2013. Predictors were FBM versus USBM and duration of residence in the United States.

Macronutrient Analysis of Modified-Fat Breast Milk Produced by 3 Methods of Fat Removal.

Background: Infants with chylothorax after congenital heart disease surgery are commonly treated using modified-fat breast milk. The effect of fat removal on breast milk macronutrients remains unclear. We compared macronutrient content of breast milk with breast milk skimmed using 3 methods, including a novel device, a cream separator.

Pediatric Feeding Disorder: Consensus Definition and Conceptual Framework.

Pediatric feeding disorders (PFDs) lack a universally accepted definition. Feeding disorders require comprehensive assessment and treatment of 4 closely related, complementary domains (medical, psychosocial, and feeding skill-based systems and associated nutritional complications). Previous diagnostic paradigms have, however, typically defined feeding disorders using the lens of a single professional discipline and fail to characterize associated functional limitations that are critical to plan appropriate interventions and improve quality of life.

Impact of a Standardized Clinical Assessment and Management Plan (SCAMP®) on growth in infants with CHD.

Background: Growth failure is prevalent among infants with CHD. A Standardized Clinical Assessment and Management Plan was introduced at Boston Children's Hospital's cardiac medical ward to identify patients with growth failure, evaluate relevant contributing conditions, and recommend a management plan including collaboration with nutrition physicians.

Objective: The objective of this study was to determine whether enrolled patients had improved growth compared with historical controls.

Reducing time to initiation and advancement of enteral feeding in an all-referral neonatal intensive care unit.

Objective: Decrease time to enteral feeding initiation and advancement.

Study Design: In our all-referral neonatal intensive care unit, we developed an evidence-based guideline addressing feeding initiation and advancement. During 6 months before and 7 months after guideline implementation, we measured time to initiate feeding, time to 100 ml/kg/day of feeding, gastric residual measurement frequency, and incidence of necrotizing enterocolitis (balancing measure).

Risk Factors for Fractures in Children Hospitalized in Intensive and Intermediate Care Units.

Background And Objectives: Fragility fractures are increasingly recognized in hospitalized children. Our study aim was to identify risk factors for fracture in children hospitalized in intensive and intermediate care units.

Methods: We conducted a retrospective, case-control study comparing the clinical characteristics of children with fractures (cases) to children without fractures (controls) matched for age, sex, hospital unit, admission quarter and year, ICU length of stay, severity of illness, and resource utilization.

Unpasteurized Shared Human Milk Use in Pediatric Inpatients: Health and Ethical Implications.

Growing evidence supporting the health benefits of human milk, particularly in the preterm population, has led to rising demand for donor human milk in NICUs and pediatric hospitals. There are no previous reports describing the use of unpasteurized shared human milk (USHM) in the hospital setting, but the use of USHM solicited from community donors through social networks appears to be common. Many pediatric hospitals permit inpatients to receive breast milk that has been screened and pasteurized by a human milk banking organization and will provide pasteurized donor human milk (PDHM) only to infants who are preterm or have specific medical conditions.

Clinical Trial of the Protein Farnesylation Inhibitors Lonafarnib, Pravastatin, and Zoledronic Acid in Children With Hutchinson-Gilford Progeria Syndrome.

Background: Hutchinson-Gilford progeria syndrome is an extremely rare, fatal, segmental premature aging syndrome caused by a mutation in LMNA yielding the farnesylated aberrant protein progerin. Without progerin-specific treatment, death occurs at an average age of 14.6 years from an accelerated atherosclerosis.

Fractures Among Inpatients in a Pediatric Hospital.

Objective: Fractures occurring in hospitalized children may be an underrecognized preventable harm with implications for current and future bone health, but few data exist regarding the clinical characteristics of these pediatric patients. We describe the clinical characteristics of patients who sustained fractures during hospitalization over a 4.5-year period at a single tertiary care center.

Cohort profile: project viva.

We established Project Viva to examine prenatal diet and other factors in relation to maternal and child health. We recruited pregnant women at their initial prenatal visit in eastern Massachusetts between 1999 and 2002. Exclusion criteria included multiple gestation, inability to answer questions in English, gestational age ≥22 weeks at recruitment and plans to move away before delivery.

Vitamin D status and hypertensive disorders in pregnancy.

Purpose: Several studies have reported increased risk of preeclampsia when 25-hyrdoxyvitamin D (25[OH]D) levels are low. The extent to which 25(OH)D may lower risk for hypertensive disorder during pregnancy remains unclear.

Methods: Among women enrolled in the Project Viva prenatal cohort in Massachusetts, we examined associations of 25(OH)D levels obtained at 16.