Apnea After 2-Month Vaccinations in Hospitalized Preterm Infants: A Randomized Clinical Trial.

Importance: Preterm infants are recommended to receive most vaccinations at the same postnatal age as term infants. Studies have inconsistently observed an increased risk for postvaccination apnea in preterm infants.

Objective: To compare the proportions of hospitalized preterm infants with apnea and other adverse events in the 48 hours after 2-month vaccinations vs after no vaccinations.

Use and utility of C-reactive protein (CRP) in neonatal early-onset sepsis: a secondary analysis of a prospective surveillance study.

Objective: Characterize C-reactive protein (CRP) within 72 postnatal hours in early-onset sepsis (EOS).

Study Design: Secondary analysis of a prospective surveillance study of neonates with EOS 2015-2017. We examined CRP use by center and neonatal characteristics, and CRP levels by time, neonatal characteristics, clinical signs, and pathogen.

Longitudinal Molecular and Serological Evidence of SARS-CoV-2 Infections and Vaccination Status: Community-Based Surveillance Study (CONTACT).

Introduction: This prospective, longitudinal, community-based study, EpidemiologiCal POpulatioN STudy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Lake CounTy, Illinois (CONTACT), investigated coronavirus disease 2019 (COVID-19) immunity, occupational risks related to SARS-CoV-2 exposure, and long-term immunoglobulin G (IgG) seroconversion kinetics.

Methods: At baseline and follow up (3, 6, and 9 months), non-hospitalized adult participants provided nasal and blood serum specimens for molecular [reverse transcription polymerase chain reaction (RT-PCR)] and serological (IgG) testing (4 November 2020-30 October 2021).

Results: At baseline, 6.

Prescribing practices of inhaled corticosteroids for premature infants in the neonatal intensive care unit.

Objective: Despite limited safety and efficacy data, inhaled corticosteroids (ICS) are prescribed to premature infants in the neonatal intensive care unit (NICU). We examined contemporary use and risk factors for ICS use in the NICU.

Study Design: Infants <33 weeks gestational age and <1500 gm birth weight discharged from Pediatrix Medical Group NICUs between 2010 and 2020 were included.

Morbidity and mortality of twins and triplets compared to singleton infants delivered between 26-34 weeks gestation in the United States.

Objective: To describe in-hospital morbidities and mortality among twins and triplets delivered at ≥26 to ≤34 weeks gestational age (GA) while controlling for prematurity and growth restriction.

Study Design: Retrospective analysis of inborn infants discharged from a neonatal intensive care unit (NICU) managed by the Pediatrix Medical Group between 2010 and 2018.

Result: Among 247 437 infants included, 27.

Use of Dexmedetomidine and Opioids in Hospitalized Preterm Infants.

Importance: Dexmedetomidine, an α2-adrenergic agonist, is not approved by the Food and Drug Administration for use in premature infants. However, the off-label use of dexmedetomidine in premature infants has increased 50-fold in the past decade. Currently, there are no large studies characterizing dexmedetomidine use in US neonatal intensive care units (NICUs) or comparing the use of dexmedetomidine vs opioids in infants.

Risk factors and epidemiology of spontaneous intestinal perforation among infants born at 22-24 weeks' gestational age.

Objective: To describe the epidemiology, risk factors, and timing of spontaneous intestinal perforation (SIP) among infants born at 22-24 weeks' gestational age (GA).

Study Design: Observational cohort study among infants born at 22-24 weeks' GA in 446 neonatal intensive care units.

Results: We identified 9712 infants, of whom 379 (3.

Urinary Tract Infection Epidemiology in NICUs in the United States.

Objective: Our objective was to characterize the incidence, associated clinical factors, timing of infection, microbiology, and incidence of concordant blood culture of urinary tract infections (UTIs) in very low birth weight (VLBW <1,500g) infants.

Study Design: Multicenter observational cohort study of VLBW infants with gestational age (GA) ≤32 weeks, still hospitalized on postnatal day 7, and discharged 2010 to 2018 from Pediatrix Medical Group neonatal intensive care units. Demographic and clinical characteristics of infants with and without UTI were compared.

Impact of Season and Other Factors on Initiation, Discontinuation, and Switching of Systemic Drug Therapy in Patients with Psoriasis: A Retrospective Study.

This study investigated whether systemic drug prescribing for psoriasis varies by season and other exacerbating factors. Eligible patients with psoriasis were assessed for each season for initiation, discontinuation, and switching of systemic drugs. A total of 360,787 patients were at risk of initiating any systemic drugs in 2016‒2019; 39,572 patients and 35,388 patients were at risk of drug discontinuation or switching to a biologic and a nonbiologic systemic drug, respectively.

Risk of seizures in a population of women with BRCA-positive metastatic breast cancer from an electronic health record database in the United States.

Background: Incidence and risk factors for seizures among women with advanced breast cancer (BC) and brain metastases are not well characterized across treatment-related or clinical subtypes. This study leveraged a large real-world dataset to describe incidence and risk factors for seizures in BRCA-associated metastatic breast cancer.

Methods: The Optum® de-identified electronic health records database was used.

EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study.

Introduction: EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT) is an observational, epidemiological study with a 9-month longitudinal follow-up of nonhospitalized persons aged 18 years or older currently living or employed in Lake County, IL. We describe the study design and report baseline characteristics of the study participants, including the proportion of participants with acute or previous SARS-CoV-2 infection at enrollment.

Methods: At enrollment and subsequent timepoints, participants recruited through digital and paper-based advertising campaigns reported their occupational and school-based exposure, risk factors, and behaviors, and provided nasal and serum specimens.

Developing Medical Technologies for Low-Resource Settings: Lessons From a Wireless Wearable Vital Signs Monitor-neoGuard.

The neoGuard™ technology is a wireless wearable vital signs monitor attached to a patient's forehead to continuously measure oxygen saturation, pulse rate, respiratory rate and temperature. Developed with feedback from more than 400 health workers, primarily in East Africa, the product has been designed to meet the unique constraints of low-resource settings. This perspective piece by the innovators of neoGuard™ and some of their key partners examines the complicated journey of taking a medical technology from concept through clinical validation and finally to market.

Neonatal invasive candidiasis: updates on clinical management and prevention.

Neonatal invasive candidiasis is an important cause of morbidity and mortality in preterm infants. The incidence of invasive candidiasis in this population has been declining in high-income settings, largely due to preventive measures, although there are still considerable variations in incidence between health-care centres. Surveillance data and large, multicentre studies in lower-income settings are not available, although preventive measures in these settings have been shown to decrease the incidence of neonatal invasive candidiasis.

Incidence and Risk Factors of Pneumonitis in Patients with Non-Small Cell Lung Cancer: An Observational Analysis of Real-World Data.

Introduction: The incidence of pneumonitis, a treatment-related adverse event (AE) in non-small cell lung cancer (NSCLC) patients, has been studied in the United States mostly through clinical trials and retrospective chart reviews. Few analyses of real-world data have been published. This study of a large nationally representative health records database estimated the incidence and predictors of pneumonitis among treated NSCLC patients between 2008 and 2018.

Validation of claims-based algorithms to identify patients with psoriasis.

Purpose: Accurately identifying patients with psoriasis (PsO) is crucial for generating real-world evidence on PsO disease course and treatment utilization.

Methods: We developed nine claims-based algorithms for PsO using a combination of the International Classification of Diseases (ICD)-9 codes, specialist visit, and medication dispensing using Medicare linked to electronic health records data (2013-2014) in two healthcare provider networks in Boston, Massachusetts. We calculated positive predictive value (PPV) and 95% confidence interval (CI) for each algorithm using the treating physician's diagnosis of PsO via chart review as the gold standard.

Chronic opioid use and complication risks in women with endometriosis: A cohort study in US administrative claims.

Background: Women with endometriosis are prescribed opioids for pain relief but may be vulnerable to chronic opioid use given their comorbidity profile.

Methods: A cohort study was conducted in the Clinformatics™ DataMart database between 2006 and 2017 comparing women aged 18-50 years with endometriosis (N = 36 373) to those without (N = 2 172 936) in terms of risk of chronic opioid use, opioid dependence diagnosis, and opioid overdose. Chronic opioid use was defined as ≥120 days' supply dispensed or ≥10 fills of an opioid during any 365-day interval.

Estimating the Effect of Elagolix Treatment for Endometriosis on Postmenopausal Bone Outcomes: A Model Bridging Phase III Trials to an Older Real-World Population.

Elagolix, a gonadotrophin-releasing hormone antagonist, is used in premenopausal women with endometriosis. There is a risk of bone loss with elagolix, but the long-term effects of BMD loss later in life cannot be directly assessed and has not been quantified. To address this gap in knowledge, this study indirectly estimated the impact of elagolix on postmenopausal fracture risk.

Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance.

Background: Completeness of adverse event (AE) reports is an important component of quality for good pharmacovigilance practices. We aimed to evaluate the impact of incorporating a measure of completeness of AE reports on quantitative signal detection.

Methods: An internal safety database from a global pharmaceutical company was used in the analysis.

Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance.

Objectives: Marketing authorization holder (MAH)-sponsored patient support programs (PSPs) are a major source of adverse event (AE) reports. The impact of reports from PSPs on the ability to detect AE signals is unclear. We compared signal detection performance using data from PSPs vs.