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BACKGROUND: Human parechovirus (HPeV) infection can result in severe disease in infants, including sepsis, seizures, brain injury, and death. In 2022, a resurgence of HPeV was noted in young infants. Spectrum of illness and outcomes remain to be fully described. METHODS: A multi-state retrospective cohort study was conducted to evaluate hospitalizations and outcomes of infants aged ≤6 months admitted in 2022 with laboratory-confirmed HPeV infection. Infants with severe disease were defined as having clinical seizures, or abnormalities on MRI or EEG during admission. Infants with severe vs non-severe disease were compared using descriptive statistics. RESULTS: 124 U.S. infants were identified with HPeV in 11 states. Cases of HPeV peaked in May and presented at a median of 25.8 days of life (0-194 d) with fever, fussiness, and poor feeding. Bacterial and other viral co-infections were rare. 33 (27%) of infants had severe neurologic disease, were more likely to present at an earlier age (13.9 vs 30 days of life, p<0.01), have preterm gestation (12% vs. 1%, p = 0.02), and present with respiratory symptoms (26% vs. 8%, p = 0.01) or apnea (41% vs. 1%, p <0.001). Subcortical white matter cytoxic cerebral edema was common in severe cases. Two infants with HPeV died during admission with severe neurologic HPeV disease; no infant with mild HPeV disease died. CONCLUSIONS: This is the largest, geographically-diverse U.S. study to describe the 2022 HPeV outbreak among infants. Longitudinal follow up of infants is needed to define predictors and outcomes of severe HPeV disease.
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The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The ACIP met June 26-28, 2024. This update summarizes the proceedings of this meeting, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include COVID-19 and influenza vaccine recommendations for the 2024-2025 season, meningococcal vaccination considerations, information regarding preferred Haemophilus influenzae type B containing vaccines for American Indian and Alaskan Native infants, and updates regarding implementation and effectiveness of RSV immunization in pregnant people and infants.
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BACKGROUND AND OBJECTIVES: Safe drinking water and closed sanitation are fundamental to health and are assumed in the United States, however, gaps remain, disproportionately affecting marginalized communities. We sought to describe household sanitation access for children in rural Alabama and local health provider knowledge of sanitation related health concerns. METHODS: Data were collected from self-administered surveys obtained from children enrolled in a larger cross-sectional study to determine soil transmitted helminthiasis prevalence in Alabama, from a survey of health providers from local federally qualified health centers and from a baseline knowledge check of Alabama health providers enrolled in an online sanitation health course. RESULTS: Surveys completed on 771 children (approximately 10% of county pediatric population) revealed less than half lived in homes connected to centralized sewers; 12% reported "straight-pipes," a method of discharging untreated sewage to the ground outside the home, and 8% reported sewage contamination of their home property in the past year. Additionally, 15% of respondents were likely to use well water. The local health providers surveyed did not include routine screening for water and sanitation failures or associated infections. Regional healthcare providers have limited knowledge of soil transmitted helminthiasis. CONCLUSIONS: A significant number of children from rural counties of Alabama with high rates of poverty reside in homes with water and sanitation challenges that predominantly affect African American families. This is an under-recognized health risk by local health providers, and its contribution to well-documented health disparities in this region is poorly understood.
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Saneamiento , Abastecimiento de Agua , Humanos , Alabama/epidemiología , Estudios Transversales , Niño , Femenino , Masculino , Preescolar , Población Rural , Adolescente , Helmintiasis/epidemiología , Helmintiasis/transmisión , Helmintiasis/prevención & control , LactanteRESUMEN
The Advisory Committee on Immunization Practices, a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The Advisory Committee on Immunization Practices met February 28 to 29, 2024, to discuss coronavirus disease 2019 vaccines, chikungunya vaccines, diphtheria-tetanus vaccine, influenza vaccines, polio vaccines, respiratory syncytial virus vaccines, meningococcal vaccines, pneumococcal vaccines, and Vaxelis (Diphtheria, Tetanus, Pertussis, Inactivated Poliovirus, Haemophilus influenzae b Conjugate, and Hepatitis B Vaccine). This update summarizes the proceedings of these meetings, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include information about changes on influenza vaccine composition, meningococcal vaccination considerations, updated guidance for children with a contraindication to pertussis-containing vaccines, and recommendations of the world's first chikungunya vaccine for certain populations.
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Comités Consultivos , Vacunas contra la COVID-19 , Vacunas Meningococicas , Humanos , Niño , Estados Unidos/epidemiología , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/uso terapéutico , Centers for Disease Control and Prevention, U.S. , COVID-19/prevención & controlRESUMEN
BACKGROUND: With more than 103 million cases and 1.1 million deaths, the COVID-19 pandemic has had devastating consequences for the health system and the well-being of the entire US population. The Rare Diseases Clinical Research Network funded by the National Institutes of Health was strategically positioned to study the impact of the pandemic on the large, vulnerable population of people living with rare diseases (RDs). OBJECTIVE: This study was designed to describe the characteristics of COVID-19 in the RD population, determine whether patient subgroups experienced increased occurrence or severity of infection and whether the pandemic changed RD symptoms and treatment, and understand the broader impact on respondents and their families. METHODS: US residents who had an RD and were <90 years old completed a web-based survey investigating self-reported COVID-19 infection, pandemic-related changes in RD symptoms and medications, access to care, and psychological impact on self and family. We estimated the incidence of self-reported COVID-19 and compared it with that in the US population; evaluated the frequency of COVID-19 symptoms according to self-reported infection; assessed infection duration, complications and need for hospitalization; assessed the influence of the COVID-19 pandemic on RD symptoms and treatment, and whether the pandemic influenced access to care, special food and nutrition, or demand for professional psychological assistance. RESULTS: Between May 2, 2020, and December 15, 2020, in total, 3413 individuals completed the survey. Most were female (2212/3413, 64.81%), White (3038/3413, 89.01%), and aged ≥25 years (2646/3413, 77.53%). Overall, 80.6% (2751/3413) did not acquire COVID-19, 2.08% (71/3413) acquired it, and 16.58% (566/3413) did not know. Self-reported cases represented an annual incidence rate of 2.2% (95% CI 1.7%-2.8%). COVID-19 cases were more than twice the expected (71 vs 30.3; P<.001). COVID-19 was associated with specific symptoms (loss of taste: odds ratio [OR] 38.9, 95% CI 22.4-67.6, loss of smell: OR 30.6, 95% CI 17.7-53.1) and multiple symptoms (>9 symptoms vs none: OR 82.5, 95% CI 29-234 and 5-9: OR 44.8, 95% CI 18.7-107). Median symptom duration was 16 (IQR 9-30) days. Hospitalization (7/71, 10%) and ventilator support (4/71, 6%) were uncommon. Respondents who acquired COVID-19 reported increased occurrence and severity of RD symptoms and use or dosage of select medications; those who did not acquire COVID-19 reported decreased occurrence and severity of RD symptoms and use of medications; those who did not know had an intermediate pattern. The pandemic made it difficult to access care, receive treatment, get hospitalized, and caused mood changes for respondents and their families. CONCLUSIONS: Self-reported COVID-19 was more frequent than expected and was associated with increased prevalence and severity of RD symptoms and greater use of medications. The pandemic negatively affected access to care and caused mood changes in the respondents and family members. Continued surveillance is necessary.
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COVID-19 , Estados Unidos/epidemiología , Humanos , Femenino , Anciano de 80 o más Años , Masculino , COVID-19/epidemiología , Pandemias , Enfermedades Raras/epidemiología , Autoinforme , HospitalizaciónRESUMEN
OBJECTIVES: Remdesivir decreases the risk of SARS-CoV-2 infection progressing to severe disease in adults. This study evaluated remdesivir safety and pharmacokinetics in infants and children. METHODS: This was a phase 2/3, open-label trial in children aged 28 days to 17 years hospitalized for polymerase chain reaction-confirmed SARS-CoV-2 infection. Participants received for ≤10 days once-daily intravenous remdesivir doses defined using physiologically based pharmacokinetic modeling (for ≥40 kg, 200 mg day 1, then 100 mg/day; for age ≥28 days and ≥3 to <40 kg, 5 mg/kg day 1, then 2.5 mg/kg/day). Sparse pharmacokinetic samples were analyzed using population-pharmacokinetic approaches for remdesivir and metabolites GS-704277 and GS-441524. RESULTS: Among 53 participants, at enrollment the median (Q1, Q3) number of days of COVID-19 symptoms was 5 (3, 7) and hospitalization was 1 (1, 3). Underlying conditions included obesity in 19 (37%), asthma in 11 (21%), and cardiac disorders in 11 (21%). Median duration of remdesivir treatment was 5 days (range, 1-10). Remdesivir treatment had no new apparent safety trends. Two participants discontinued treatment because of adverse events including elevated transaminases; both had elevated transaminases at baseline. Three deaths occurred during treatment (and 1 after). When compared with phase 3 adult data, estimated mean pediatric parameters (area under the concentration-time curve over 1 dosing interval, AUCτ, Cmax, and Cτ) were largely overlapping but modestly increased (remdesivir, 33%-129%; GS-704277, 37%-124%; GS-441524, 0%-60%). Recovery occurred for 62% of participants on day 10 and 83% at last assessment. CONCLUSIONS: In infants and children with COVID-19, the doses of remdesivir evaluated provided drug exposure similar to adult dosing. In this study with a small sample size, no new safety concerns were observed.
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Adenosina Monofosfato/análogos & derivados , Alanina/análogos & derivados , COVID-19 , Niño Hospitalizado , Adulto , Lactante , Humanos , Niño , Tratamiento Farmacológico de COVID-19 , SARS-CoV-2 , Pirroles , TransaminasasRESUMEN
OBJECTIVE: The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus-associated sensorineural hearing loss. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine. RESULTS: Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome. CONCLUSIONS: In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus-associated sensorineural hearing loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01649869.
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Antivirales , Infecciones por Citomegalovirus , Ganciclovir , Pérdida Auditiva Sensorineural , Valganciclovir , Humanos , Infecciones por Citomegalovirus/tratamiento farmacológico , Infecciones por Citomegalovirus/congénito , Infecciones por Citomegalovirus/complicaciones , Valganciclovir/uso terapéutico , Valganciclovir/administración & dosificación , Pérdida Auditiva Sensorineural/tratamiento farmacológico , Pérdida Auditiva Sensorineural/virología , Pérdida Auditiva Sensorineural/etiología , Antivirales/uso terapéutico , Antivirales/administración & dosificación , Masculino , Femenino , Método Doble Ciego , Lactante , Administración Oral , Ganciclovir/análogos & derivados , Ganciclovir/uso terapéutico , Ganciclovir/administración & dosificación , Preescolar , Resultado del Tratamiento , Carga Viral , Recién NacidoRESUMEN
The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The ACIP met October 25 to 26, 2023, to discuss meningococcal vaccines, mpox vaccines, respiratory syncytial virus (RSV) vaccines, influenza vaccines, coronavirus disease 2019 (COVID-19) vaccines, and the combined pediatric and adult immunization schedules for 2024. The ACIP also held special meetings on September 12 and September 22 to discuss COVID-19 2023-2024 vaccine recommendations and RSV immunization in pregnant women. This update summarizes the proceedings of these meetings that are most relevant to the pediatric population. Major updates for pediatric clinicians include recommendations for XBB monovalent COVID-19 immunization for the 2023-2024 respiratory season, the recently licensed pentavalent meningococcal conjugate vaccine and mpox vaccination in high-risk young adults, and discussion regarding the parallel strategies of protection against RSV disease in infants via maternal immunization during pregnancy or direct prophylaxis of infants with nirsevimab.
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COVID-19 , Gripe Humana , Vacunas Meningococicas , Neisseria meningitidis , Lactante , Adulto Joven , Niño , Humanos , Femenino , Embarazo , Vacunas Meningococicas/uso terapéutico , Gripe Humana/prevención & control , Comités Consultivos , Virus Sincitiales Respiratorios , COVID-19/prevención & control , InmunizaciónRESUMEN
The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The ACIP met June 21-23, 2023, to discuss respiratory syncytial virus (RSV) vaccines, influenza vaccines, pneumococcal vaccines, meningococcal vaccines, and COVID-19 vaccines. The ACIP also held a special meeting on August 3, 2023, to discuss RSV prophylaxis in infants. This update summarizes the proceedings of these meetings that are most relevant to the pediatric population. Major updates for pediatric clinicians include a new recommendation for the monoclonal antibody nirsevimab for prevention of RSV disease in all infants, recommendations regarding use of 20-valent pneumococcal conjugate vaccine, and discussion of potential forthcoming changes to meningococcal and COVID-19 vaccination recommendations.
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Vacunas contra la Influenza , Vacunas Meningococicas , Lactante , Estados Unidos , Niño , Humanos , Vacunas contra la COVID-19 , Comités Consultivos , Virus Sincitiales Respiratorios , Inmunización , Vacunación , Vacunas contra la Influenza/uso terapéutico , Vacunas Meningococicas/uso terapéutico , Esquemas de InmunizaciónRESUMEN
The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts who provides expert advice to the Centers for Disease Control and Prevention, normally meets three times per year to develop U.S. vaccine recommendations. The ACIP met on February 22-24, 2023, to discuss mpox vaccine, influenza vaccines, pneumococcus vaccines, meningococci vaccines, polio vaccines, respiratory syncytial virus (RSV) vaccine, chikungunya vaccines, dengue vaccines, and COVID-19 vaccines.
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COVID-19 , Vacunas contra la Influenza , Vacunas contra Virus Sincitial Respiratorio , Estados Unidos , Humanos , Lactante , Comités Consultivos , Vacunas contra la COVID-19 , Esquemas de Inmunización , InmunizaciónRESUMEN
Though primarily used to improve neurodevelopmental outcomes, suppressive oral acyclovir therapy following neonatal herpes simplex virus disease also decreases cutaneous recurrences. Skin recurrences can still occur, however, and understanding their frequency is helpful in managing patients with this rare disease.
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Antivirales , Herpes Simple , Recién Nacido , Humanos , Antivirales/uso terapéutico , Herpes Simple/tratamiento farmacológico , Aciclovir/uso terapéutico , Recurrencia , SimplexvirusRESUMEN
Congenital cytomegalovirus (cCMV) infection is the leading non-genetic cause of long-term neurological and sensory sequelae, the most common being sensorineural hearing loss (SNHL). Standard therapy for infants with symptomatic cCMV is valganciclovir for six months. However, little is known about the effects of antiviral therapy on CMV diversity while patients are on treatment. In this study, CMV variation was analyzed from urine specimens isolated from two patients with cCMV shortly after birth and at seven months. One was treated with valganciclovir for six weeks and the other for six months. In order to track these variants a novel bioinformatic approach was employed to analyze changes in low frequency variants over time. In the infant receiving antivirals for only six weeks, there was a fourfold increase in variation in UL97 from the seven month specimen. Furthermore, an eightfold increase in variation was seen in UL83 (pp65) with seven potential escape mutations occurring, and a twofold increase in UL73 (gN). In contrast variation did not increase or was reduced in these coding regions in the infant receiving valganciclovir for six months. However, there were increases in other CMV regions in samples isolated from both patients indicating further longitudinal studies are warranted to better understand the interplay between CMV diversity, antiviral therapy and patient outcome.
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Infecciones por Citomegalovirus , Pérdida Auditiva Sensorineural , Antivirales/farmacología , Antivirales/uso terapéutico , Citomegalovirus , Pérdida Auditiva Sensorineural/congénito , Humanos , Lactante , Recién Nacido , Valganciclovir/farmacología , Valganciclovir/uso terapéuticoAsunto(s)
Herpes Simple , Complicaciones Infecciosas del Embarazo , Femenino , Humanos , Recién Nacido , EmbarazoRESUMEN
BACKGROUND AND OBJECTIVES: Clinicians evaluating for herpes simplex virus (HSV) in febrile infants must balance detection with overtesting, and there is no universally accepted approach to risk stratification. We aimed to describe variation in diagnostic evaluation and empirical acyclovir treatment of infants aged 0 to 60 days presenting with fever and determine the association between testing and length of stay (LOS). METHODS: In this retrospective 44-hospital observational study, we used the Pediatric Health Information System database to identify infants aged ≤60 days evaluated for fever in emergency departments from January 2016 through December 2017. We described hospital-level variation in laboratory testing, including HSV, imaging and other diagnostic evaluations, acyclovir use, and LOS. We assessed the relationship between HSV testing and LOS using generalized linear mixed effects models adjusted for age and illness severity. RESULTS: In 24 535 encounters for fever, the median HSV testing frequency across hospitals was 35.6% (interquartile range [IQR]: 28.5%-53.5%) for infants aged 0 to 21 days and 12% (IQR: 8.6%-15.7%) for infants aged 22 to 60 days. Among HSV-tested patients, median acyclovir use across hospitals was 79.2% (IQR: 68.1%-89.7%) for those aged 0 to 21 days and 63.6% (IQR: 44.1%-73%) for those aged 22 to 60 days. The prevalence of additional testing varied substantially by hospital and age group. Risk-adjusted LOS for HSV-tested infants was significantly longer than risk-adjusted LOS for those not tested (2.6 vs 1.9 days, P < .001). CONCLUSIONS: Substantial variation exists in diagnostic evaluation and acyclovir use, and infants who received HSV testing had a longer LOS than infants who did not. This variability supports the need for further studies to help clinicians better risk-stratify febrile infants and to guide HSV testing and treatment decisions.
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Aciclovir , Herpes Simple , Aciclovir/uso terapéutico , Niño , Pruebas Diagnósticas de Rutina , Herpes Simple/diagnóstico , Herpes Simple/tratamiento farmacológico , Herpes Simple/epidemiología , Humanos , Lactante , Estudios Retrospectivos , SimplexvirusRESUMEN
This article defines neonatal herpes simplex virus (HSV) disease and describes the progress over the past 40 years that has revolutionized the management of HSV disease in neonates to improve their outcomes. These advancements include the introduction of acyclovir in the 1980s, polymerase chain reaction (PCR) for the detection of HSV DNA in the 1990s, and recommendations on managing infants born to mothers with active genital lesions. Despite these advancements, however, there remain high morbidity and mortality in affected neonates, with need for continued improvement. Areas of high interest include vaccine development and rapid PCR detection at time of delivery.
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Herpes Genital , Herpes Simple , Complicaciones Infecciosas del Embarazo , Aciclovir/uso terapéutico , Antivirales/uso terapéutico , Femenino , Herpes Genital/diagnóstico , Herpes Genital/tratamiento farmacológico , Herpes Genital/epidemiología , Herpes Simple/diagnóstico , Herpes Simple/tratamiento farmacológico , Herpes Simple/epidemiología , Humanos , Lactante , Recién Nacido , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Complicaciones Infecciosas del Embarazo/epidemiología , SimplexvirusAsunto(s)
Lesiones Encefálicas , COVID-19 , Sustancia Blanca , Humanos , Lactante , Recién Nacido , SARS-CoV-2 , ConvulsionesRESUMEN
BACKGROUND: In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products. METHODS: A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion. RESULTS: The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis. CONCLUSIONS: Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.