首页 > 最新文献

Pediatrics最新文献

英文 中文
Birth Prevalence of Gastroschisis in the United States: 2016-2022.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-05 DOI: 10.1542/peds.2024-068696
Jennifer M Schuh, Erwin Cabacungan, Amy J Wagner

Objectives: The prevalence of gastroschisis has been increasing for decades globally across all ages and races/ethnicities and is one of few birth defects with rising prevalence in both developing and developed countries. However, there are some indications that rates in the United States may be declining. We aim to investigate national gastroschisis prevalence with 3 independent large-scale databases. We hypothesize that from 2016-2022, the data will congruently reveal a decline in gastroschisis prevalence in the United States.

Methods: This study is a retrospective cross-sectional database review of 3 national datasets: 1 clinical outcomes-based dataset (the American College of Surgeons [ACS] National Surgical Quality Improvement Program-Pediatric [NSQIP-P] dataset), 1 administrative dataset (the Healthcare Cost and Utilization Project-National Inpatient Sample [HCUP-NIS]), and 1 public health-based dataset (the Center for Disease Control and Prevention Wide-ranging ONline Data for Epidemiologic Research [CDC WONDER]). Datasets were analyzed from 2016-2021/2022 for gastroschisis prevalence.

Results: From 2016-2022, the ACS NSQIP-P dataset revealed a decline in gastroschisis frequency from 0.32 to 0.19 per 100 infants. The HCUP-NIS dataset demonstrated a decline from 3.32 to 2.46 per 10 000 births. CDC WONDER data revealed a decline from 2.43 to 1.60 per 10 000 births.

Conclusion: From 2016-2022, 3 large-scale national datasets congruently reveal a decline in gastroschisis prevalence in the United States for the first time in decades. The cause is likely multifactorial and should be further investigated.

{"title":"Birth Prevalence of Gastroschisis in the United States: 2016-2022.","authors":"Jennifer M Schuh, Erwin Cabacungan, Amy J Wagner","doi":"10.1542/peds.2024-068696","DOIUrl":"https://doi.org/10.1542/peds.2024-068696","url":null,"abstract":"<p><strong>Objectives: </strong>The prevalence of gastroschisis has been increasing for decades globally across all ages and races/ethnicities and is one of few birth defects with rising prevalence in both developing and developed countries. However, there are some indications that rates in the United States may be declining. We aim to investigate national gastroschisis prevalence with 3 independent large-scale databases. We hypothesize that from 2016-2022, the data will congruently reveal a decline in gastroschisis prevalence in the United States.</p><p><strong>Methods: </strong>This study is a retrospective cross-sectional database review of 3 national datasets: 1 clinical outcomes-based dataset (the American College of Surgeons [ACS] National Surgical Quality Improvement Program-Pediatric [NSQIP-P] dataset), 1 administrative dataset (the Healthcare Cost and Utilization Project-National Inpatient Sample [HCUP-NIS]), and 1 public health-based dataset (the Center for Disease Control and Prevention Wide-ranging ONline Data for Epidemiologic Research [CDC WONDER]). Datasets were analyzed from 2016-2021/2022 for gastroschisis prevalence.</p><p><strong>Results: </strong>From 2016-2022, the ACS NSQIP-P dataset revealed a decline in gastroschisis frequency from 0.32 to 0.19 per 100 infants. The HCUP-NIS dataset demonstrated a decline from 3.32 to 2.46 per 10 000 births. CDC WONDER data revealed a decline from 2.43 to 1.60 per 10 000 births.</p><p><strong>Conclusion: </strong>From 2016-2022, 3 large-scale national datasets congruently reveal a decline in gastroschisis prevalence in the United States for the first time in decades. The cause is likely multifactorial and should be further investigated.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143557672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving Human Papillomavirus Vaccine Administration Using Medical-Dental Integration.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-05 DOI: 10.1542/peds.2024-066639
Jessica L Jack, Amy B Stein, Laura J Podewils, Kristin Breslin, Scott Hamilton, Joshua T B Williams

Background and objectives: Children aged 9 years and older visit dental providers more frequently than medical providers. Routine dental visits include screenings for human papillomavirus (HPV)-related oropharyngeal cancers and provide opportunities for HPV vaccination. The objective of this project was to implement a medical-dental integration (MDI) program to enhance HPV vaccine administration among children aged 9 to 17 years being seen at dental clinics.

Methods: Between June 1, 2021, and May 31, 2023, we conducted a quality improvement initiative at dental clinics within a large, integrated, safety-net health care system in Denver, Colorado. We implemented an MDI program in which dental professionals recommended the HPV vaccine and integrated medical staff administered the vaccine during the appointment. The primary outcome assessed was the HPV vaccine receipt on the same day as the dental visit. We used interrupted time series and multivariate regression models to assess the intervention's effectiveness.

Results: During the intervention period, this program reached 2781 dental visits, with 77% of children covered by Medicaid and 21% uninsured. Among them, 60% identified as Hispanic, 23% identified as Black, and 40% preferred to speak Spanish. Interrupted time series analysis revealed an immediate 9.8% improvement. The overall vaccination rate at eligible visits increased from 5.3% to 13.9% during the 1-year intervention. The adjusted odds ratio (aOR) of HPV vaccination at a dental visit was 4 times higher during the intervention (aOR, 4.37; 95% CI, 3.22-5.92) compared with preintervention.

Conclusions: MDI was an effective intervention to increase HPV vaccination rates at a safety-net health care system.

{"title":"Improving Human Papillomavirus Vaccine Administration Using Medical-Dental Integration.","authors":"Jessica L Jack, Amy B Stein, Laura J Podewils, Kristin Breslin, Scott Hamilton, Joshua T B Williams","doi":"10.1542/peds.2024-066639","DOIUrl":"https://doi.org/10.1542/peds.2024-066639","url":null,"abstract":"<p><strong>Background and objectives: </strong>Children aged 9 years and older visit dental providers more frequently than medical providers. Routine dental visits include screenings for human papillomavirus (HPV)-related oropharyngeal cancers and provide opportunities for HPV vaccination. The objective of this project was to implement a medical-dental integration (MDI) program to enhance HPV vaccine administration among children aged 9 to 17 years being seen at dental clinics.</p><p><strong>Methods: </strong>Between June 1, 2021, and May 31, 2023, we conducted a quality improvement initiative at dental clinics within a large, integrated, safety-net health care system in Denver, Colorado. We implemented an MDI program in which dental professionals recommended the HPV vaccine and integrated medical staff administered the vaccine during the appointment. The primary outcome assessed was the HPV vaccine receipt on the same day as the dental visit. We used interrupted time series and multivariate regression models to assess the intervention's effectiveness.</p><p><strong>Results: </strong>During the intervention period, this program reached 2781 dental visits, with 77% of children covered by Medicaid and 21% uninsured. Among them, 60% identified as Hispanic, 23% identified as Black, and 40% preferred to speak Spanish. Interrupted time series analysis revealed an immediate 9.8% improvement. The overall vaccination rate at eligible visits increased from 5.3% to 13.9% during the 1-year intervention. The adjusted odds ratio (aOR) of HPV vaccination at a dental visit was 4 times higher during the intervention (aOR, 4.37; 95% CI, 3.22-5.92) compared with preintervention.</p><p><strong>Conclusions: </strong>MDI was an effective intervention to increase HPV vaccination rates at a safety-net health care system.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143557675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Home-Delivered Pediatric Weight Management for Low-Income Families: A Randomized Controlled Trial.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-05 DOI: 10.1542/peds.2024-069282
Bradley M Appelhans, Simone A French, Molly A Martin, Karen J Lui, Lauren E Bradley, Tricia J Johnson, Heng Wang, Imke Janssen, Sumihiro Suzuki

Background and objectives: Children from lower-income households lose less weight in family-based weight management interventions, likely due to barriers to treatment attendance and adherence. The CHECK randomized controlled trial tested whether delivering pediatric weight management interventions in the home improves weight loss outcomes relative to clinic-delivered intervention.

Methods: Enrolled families included 269 children (137 boys) who were aged 6 to 12 years, had overweight/obesity, and lived in lower-income English- or Spanish-speaking households in Chicago, Illinois (2017-2022). All families received a 12-month pediatric weight management intervention with 18 planned in-person sessions and 12 planned telephone contacts. The sole difference between arms was the location (home vs clinic) of in-person intervention sessions. Intention-to-treat analyses compared treatment arms on 12-month change in BMI z-score (zBMI), intervention session attendance and contact time, and secondary clinical outcomes.

Results: Twelve-month zBMI change did not differ (P = .58) between the home-delivered (n = 133; -0.031, SD = 0.26) and clinic-delivered arms (n = 136; -0.002, SD = 0.30). Across both arms, session attendance and total contact time predicted larger decreases in zBMI. Both variables were higher in the home-delivered arm (median = 11 sessions, 500 minutes) than the clinic-delivered arm (median = 6.5 sessions, 315.5 minutes; P values < .001). Post hoc analyses indicated that home-delivered (vs clinic-delivered) intervention led to 0.03 (SE = 0.008, P = .0004) greater zBMI reductions across time points prior to the COVID-19 pandemic, but not after.

Conclusions: Home delivery did not improve overall 12-month weight loss outcomes. Home-delivered intervention did increase session attendance and contact time and may have had beneficial weight loss effects prior to the COVID-19 pandemic.

{"title":"Home-Delivered Pediatric Weight Management for Low-Income Families: A Randomized Controlled Trial.","authors":"Bradley M Appelhans, Simone A French, Molly A Martin, Karen J Lui, Lauren E Bradley, Tricia J Johnson, Heng Wang, Imke Janssen, Sumihiro Suzuki","doi":"10.1542/peds.2024-069282","DOIUrl":"https://doi.org/10.1542/peds.2024-069282","url":null,"abstract":"<p><strong>Background and objectives: </strong>Children from lower-income households lose less weight in family-based weight management interventions, likely due to barriers to treatment attendance and adherence. The CHECK randomized controlled trial tested whether delivering pediatric weight management interventions in the home improves weight loss outcomes relative to clinic-delivered intervention.</p><p><strong>Methods: </strong>Enrolled families included 269 children (137 boys) who were aged 6 to 12 years, had overweight/obesity, and lived in lower-income English- or Spanish-speaking households in Chicago, Illinois (2017-2022). All families received a 12-month pediatric weight management intervention with 18 planned in-person sessions and 12 planned telephone contacts. The sole difference between arms was the location (home vs clinic) of in-person intervention sessions. Intention-to-treat analyses compared treatment arms on 12-month change in BMI z-score (zBMI), intervention session attendance and contact time, and secondary clinical outcomes.</p><p><strong>Results: </strong>Twelve-month zBMI change did not differ (P = .58) between the home-delivered (n = 133; -0.031, SD = 0.26) and clinic-delivered arms (n = 136; -0.002, SD = 0.30). Across both arms, session attendance and total contact time predicted larger decreases in zBMI. Both variables were higher in the home-delivered arm (median = 11 sessions, 500 minutes) than the clinic-delivered arm (median = 6.5 sessions, 315.5 minutes; P values < .001). Post hoc analyses indicated that home-delivered (vs clinic-delivered) intervention led to 0.03 (SE = 0.008, P = .0004) greater zBMI reductions across time points prior to the COVID-19 pandemic, but not after.</p><p><strong>Conclusions: </strong>Home delivery did not improve overall 12-month weight loss outcomes. Home-delivered intervention did increase session attendance and contact time and may have had beneficial weight loss effects prior to the COVID-19 pandemic.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143557674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
GLP-1 Receptor Agonists in Pediatric and Adolescent Obesity.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-04 DOI: 10.1542/peds.2024-068119
Margaret A Stefater-Richards, Grace Jhe, Yanjia Jason Zhang

Obesity remains highly prevalent among children in the United States and is associated with an ever-increasing burden of obesity-related diseases. Effective pediatric obesity prevention and treatment will require both societal interventions and health care system innovation. One recent advancement is the approval of glucagon-like peptide-1 receptor agonists (GLP-1RAs) for use in adolescents. GLP-1RAs are notable for their effectiveness in weight management and in their ability to ameliorate obesity-related diseases. GLP-1RAs can be an important part of a comprehensive treatment plan for pediatric patients seeking obesity care, and we will review the pediatric clinician's considerations for their effective use. We discuss the history of obesity pharmacology and development of GLP-1RAs. We review the indications for use and common adverse reactions. We highlight the importance of mental health care for obesity treatment, with a focus on disordered eating behaviors and their intersection with obesity and pharmacologic treatment of obesity. Nutrition remains an important issue for obesity prevention and management, and we highlight nutritional concerns during GLP-1RA therapy. Finally, we discuss health inequities in obesity, the dangers of perpetuating these inequities if GLP-1RA access remains biased, and the opportunities for improvement.

{"title":"GLP-1 Receptor Agonists in Pediatric and Adolescent Obesity.","authors":"Margaret A Stefater-Richards, Grace Jhe, Yanjia Jason Zhang","doi":"10.1542/peds.2024-068119","DOIUrl":"https://doi.org/10.1542/peds.2024-068119","url":null,"abstract":"<p><p>Obesity remains highly prevalent among children in the United States and is associated with an ever-increasing burden of obesity-related diseases. Effective pediatric obesity prevention and treatment will require both societal interventions and health care system innovation. One recent advancement is the approval of glucagon-like peptide-1 receptor agonists (GLP-1RAs) for use in adolescents. GLP-1RAs are notable for their effectiveness in weight management and in their ability to ameliorate obesity-related diseases. GLP-1RAs can be an important part of a comprehensive treatment plan for pediatric patients seeking obesity care, and we will review the pediatric clinician's considerations for their effective use. We discuss the history of obesity pharmacology and development of GLP-1RAs. We review the indications for use and common adverse reactions. We highlight the importance of mental health care for obesity treatment, with a focus on disordered eating behaviors and their intersection with obesity and pharmacologic treatment of obesity. Nutrition remains an important issue for obesity prevention and management, and we highlight nutritional concerns during GLP-1RA therapy. Finally, we discuss health inequities in obesity, the dangers of perpetuating these inequities if GLP-1RA access remains biased, and the opportunities for improvement.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recommendations for Pneumonia in Hospitalized Children With Neurologic Impairment.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-04 DOI: 10.1542/peds.2024-067216
Joanna E Thomson, Abigail Musial, Rebecca Steuart, Dan Benscoter, Scott Callahan, David B Haslam, Michael Rafferty, Christine M White, Dianna Bosse, Kristen M Timmons, Maria T Britto, Amanda C Schondelmeyer, Samir S Shah

Objectives: Children with neurologic impairment (CNI) are commonly hospitalized with pneumonia but are often excluded from practice guidelines. We sought to develop evidence-based, expert-panel endorsed recommendations for the care of CNI hospitalized with pneumonia.

Methods: We conducted an extensive literature search that formed the basis of drafted candidate recommendations for diagnostic testing, antimicrobial treatment, airway clearance, and discharge criteria. We convened a national panel of individuals with expertise in nursing, pediatric medicine (infectious diseases, pulmonology, hospital medicine, complex care), and family advocacy. Using the RAND/University of California Los Angeles Appropriateness Method, including a moderated panel meeting, panelists rated recommendations for appropriateness in 2 sequential rounds.

Results: The panel assessed 73 drafted recommendations for diagnostic testing, antimicrobial treatment, airway clearance, and discharge criteria for CNI hospitalized with pneumonia. After modifications to 2 of the drafted recommendations, the panel reached agreement on the appropriateness of 72 recommendations. Recommendations include management that minimizes the use of broad-spectrum antibiotics. Recommendations further emphasize collaboration with respiratory therapists for airway clearance and with families, outpatient managing physicians, and homecare providers for discharge. The recommendations for pneumonia diagnosis and management account for heterogeneity in the patient population, including comorbidities and risk factors (eg, aspiration risk), as well as severity of presenting illness.

Conclusion: Recommendations for appropriate diagnostic testing, antimicrobial treatment, airway clearance, and discharge criteria for CNI hospitalized with pneumonia can be used to inform clinical care. The effect of these recommendations on patient- and family-centered outcomes should be studied.

{"title":"Recommendations for Pneumonia in Hospitalized Children With Neurologic Impairment.","authors":"Joanna E Thomson, Abigail Musial, Rebecca Steuart, Dan Benscoter, Scott Callahan, David B Haslam, Michael Rafferty, Christine M White, Dianna Bosse, Kristen M Timmons, Maria T Britto, Amanda C Schondelmeyer, Samir S Shah","doi":"10.1542/peds.2024-067216","DOIUrl":"https://doi.org/10.1542/peds.2024-067216","url":null,"abstract":"<p><p></p><p><strong>Objectives: </strong>Children with neurologic impairment (CNI) are commonly hospitalized with pneumonia but are often excluded from practice guidelines. We sought to develop evidence-based, expert-panel endorsed recommendations for the care of CNI hospitalized with pneumonia.</p><p><strong>Methods: </strong>We conducted an extensive literature search that formed the basis of drafted candidate recommendations for diagnostic testing, antimicrobial treatment, airway clearance, and discharge criteria. We convened a national panel of individuals with expertise in nursing, pediatric medicine (infectious diseases, pulmonology, hospital medicine, complex care), and family advocacy. Using the RAND/University of California Los Angeles Appropriateness Method, including a moderated panel meeting, panelists rated recommendations for appropriateness in 2 sequential rounds.</p><p><strong>Results: </strong>The panel assessed 73 drafted recommendations for diagnostic testing, antimicrobial treatment, airway clearance, and discharge criteria for CNI hospitalized with pneumonia. After modifications to 2 of the drafted recommendations, the panel reached agreement on the appropriateness of 72 recommendations. Recommendations include management that minimizes the use of broad-spectrum antibiotics. Recommendations further emphasize collaboration with respiratory therapists for airway clearance and with families, outpatient managing physicians, and homecare providers for discharge. The recommendations for pneumonia diagnosis and management account for heterogeneity in the patient population, including comorbidities and risk factors (eg, aspiration risk), as well as severity of presenting illness.</p><p><strong>Conclusion: </strong>Recommendations for appropriate diagnostic testing, antimicrobial treatment, airway clearance, and discharge criteria for CNI hospitalized with pneumonia can be used to inform clinical care. The effect of these recommendations on patient- and family-centered outcomes should be studied.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving the Infrastructure for Pediatric Medical Device Trials at Children's Hospitals.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-04 DOI: 10.1542/peds.2024-066974
Juan C Espinoza, Grzegorz Zapotoczny, Kolaleh Eskandanian, Joshua Dienstman, R Brandon Hunter, Robert Levy, Michael Harrison, Hanmin Lee, Chester J Koh

The shortage of novel pediatric devices that accommodate the unique needs of children exists due to several scientific, clinical, regulatory, and financial barriers. This global unmet need is being addressed in the United States by multiple stakeholders including the Food and Drug Administration (FDA) and its Pediatric Device Consortia (PDC) grant program. One critical area of interest is the suboptimal medical device clinical trial infrastructure that currently exists in academic medical centers and compounded at children's hospitals. Although pediatric drug clinical trial infrastructure is often well developed at many children's hospitals, these capabilities do not necessarily translate to pediatric device trials. The chief challenge to address is the recognition of differences in conducting device vs drug trials. We need to shift the paradigm by introducing best practices and a set of tools and job aids to assist the stakeholders of device trials at children's hospitals. Pediatric medical device clinical trial support has unique infrastructure needs and barriers compared to trials carried out of adult medical devices and drugs. Well-coordinated cross-sector collaboration is needed to advance the state of pediatric medical devices. To assess these gaps and challenges, surveys and interviews were conducted with key leaders at each of the children's hospitals primarily associated with the 5 FDA-supported PDCs. Reviews of pediatric device clinical trials were performed at each institution with the goal of identifying the common denominators and specifics of best practices, challenges, and areas of improvement for conducting and supporting pediatric device trials.

{"title":"Improving the Infrastructure for Pediatric Medical Device Trials at Children's Hospitals.","authors":"Juan C Espinoza, Grzegorz Zapotoczny, Kolaleh Eskandanian, Joshua Dienstman, R Brandon Hunter, Robert Levy, Michael Harrison, Hanmin Lee, Chester J Koh","doi":"10.1542/peds.2024-066974","DOIUrl":"https://doi.org/10.1542/peds.2024-066974","url":null,"abstract":"<p><p>The shortage of novel pediatric devices that accommodate the unique needs of children exists due to several scientific, clinical, regulatory, and financial barriers. This global unmet need is being addressed in the United States by multiple stakeholders including the Food and Drug Administration (FDA) and its Pediatric Device Consortia (PDC) grant program. One critical area of interest is the suboptimal medical device clinical trial infrastructure that currently exists in academic medical centers and compounded at children's hospitals. Although pediatric drug clinical trial infrastructure is often well developed at many children's hospitals, these capabilities do not necessarily translate to pediatric device trials. The chief challenge to address is the recognition of differences in conducting device vs drug trials. We need to shift the paradigm by introducing best practices and a set of tools and job aids to assist the stakeholders of device trials at children's hospitals. Pediatric medical device clinical trial support has unique infrastructure needs and barriers compared to trials carried out of adult medical devices and drugs. Well-coordinated cross-sector collaboration is needed to advance the state of pediatric medical devices. To assess these gaps and challenges, surveys and interviews were conducted with key leaders at each of the children's hospitals primarily associated with the 5 FDA-supported PDCs. Reviews of pediatric device clinical trials were performed at each institution with the goal of identifying the common denominators and specifics of best practices, challenges, and areas of improvement for conducting and supporting pediatric device trials.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adapting a Risk Prediction Tool for Neonatal Opioid Withdrawal Syndrome.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-03-03 DOI: 10.1542/peds.2024-068673
Thomas J Reese, Andrew D Wiese, Ashley A Leech, Henry J Domenico, Elizabeth A McNeer, Sharon E Davis, Michael E Matheny, Adam Wright, Stephen W Patrick

Background: The American Academy of Pediatrics recommends up to 7 days of observation for neonatal opioid withdrawal syndrome (NOWS) in infants with chronic opioid exposure. However, many of these infants will not develop NOWS, and infants with seemingly less exposure to opioids may develop severe NOWS that requires in-hospital pharmacotherapy. We adapted and validated a prediction model to help clinicians identify infants at birth who will develop severe NOWS.

Methods: This prognostic study included 33 991 births. Severe NOWS was defined as administration of oral morphine. We applied logistic regression with a least absolute shrinkage selection operator approach to develop a severe NOWS prediction model using 37 predictors. To contrast the model with guideline screening criteria, we conducted a decision curve analysis with chronic opioid exposure defined as the mother receiving a diagnosis for opioid use disorder (OUD) or a prescription for long-acting opioids before delivery.

Results: A total of 108 infants were treated with oral morphine for NOWS, and 1243 infants had chronic opioid exposure. The model was highly discriminative, with an area under the receiver operating curve of 0.959 (95% CI, 0.940-0.976). The strongest predictor was mothers' diagnoses of OUD (adjusted odds ratio, 47.0; 95% CI, 26.7-82.7). The decision curve analysis shows a higher benefit with the model across all levels of risk, compared with using the guideline criteria.

Conclusion: Risk prediction for severe NOWS at birth may better support clinicians in tailoring nonpharmacologic measures and deciding whether to extend birth hospitalization than screening for chronic opioid exposure alone.

背景:美国儿科学会建议对长期暴露于阿片类药物的婴儿进行长达 7 天的新生儿阿片类药物戒断综合征(NOWS)观察。然而,这些婴儿中有许多不会出现 NOWS,而阿片类药物暴露似乎较少的婴儿可能会出现严重的 NOWS,需要进行院内药物治疗。我们改编并验证了一个预测模型,以帮助临床医生在婴儿出生时识别出会出现严重 NOWS 的婴儿:这项预后研究包括 33 991 名新生儿。重度 NOWS 的定义是口服吗啡。我们采用逻辑回归和最小绝对缩减选择算子方法,利用 37 个预测因子建立了严重 NOWS 预测模型。为了将该模型与指南筛选标准进行对比,我们进行了一项决策曲线分析,将长期阿片类药物暴露定义为母亲在分娩前接受阿片类药物使用障碍(OUD)诊断或开具长效阿片类药物处方:共有108名婴儿因NOWS接受了口服吗啡治疗,1243名婴儿有长期阿片类药物暴露。该模型具有很高的区分度,接收器工作曲线下面积为 0.959(95% CI,0.940-0.976)。最强的预测因子是母亲的 OUD 诊断(调整后的几率比为 47.0;95% CI 为 26.7-82.7)。决策曲线分析表明,与使用指南标准相比,该模型在所有风险水平上的收益都更高:结论:与单独筛查慢性阿片类药物暴露相比,出生时严重NOWS的风险预测能更好地帮助临床医生定制非药物治疗措施,并决定是否延长出生时的住院时间。
{"title":"Adapting a Risk Prediction Tool for Neonatal Opioid Withdrawal Syndrome.","authors":"Thomas J Reese, Andrew D Wiese, Ashley A Leech, Henry J Domenico, Elizabeth A McNeer, Sharon E Davis, Michael E Matheny, Adam Wright, Stephen W Patrick","doi":"10.1542/peds.2024-068673","DOIUrl":"https://doi.org/10.1542/peds.2024-068673","url":null,"abstract":"<p><strong>Background: </strong>The American Academy of Pediatrics recommends up to 7 days of observation for neonatal opioid withdrawal syndrome (NOWS) in infants with chronic opioid exposure. However, many of these infants will not develop NOWS, and infants with seemingly less exposure to opioids may develop severe NOWS that requires in-hospital pharmacotherapy. We adapted and validated a prediction model to help clinicians identify infants at birth who will develop severe NOWS.</p><p><strong>Methods: </strong>This prognostic study included 33 991 births. Severe NOWS was defined as administration of oral morphine. We applied logistic regression with a least absolute shrinkage selection operator approach to develop a severe NOWS prediction model using 37 predictors. To contrast the model with guideline screening criteria, we conducted a decision curve analysis with chronic opioid exposure defined as the mother receiving a diagnosis for opioid use disorder (OUD) or a prescription for long-acting opioids before delivery.</p><p><strong>Results: </strong>A total of 108 infants were treated with oral morphine for NOWS, and 1243 infants had chronic opioid exposure. The model was highly discriminative, with an area under the receiver operating curve of 0.959 (95% CI, 0.940-0.976). The strongest predictor was mothers' diagnoses of OUD (adjusted odds ratio, 47.0; 95% CI, 26.7-82.7). The decision curve analysis shows a higher benefit with the model across all levels of risk, compared with using the guideline criteria.</p><p><strong>Conclusion: </strong>Risk prediction for severe NOWS at birth may better support clinicians in tailoring nonpharmacologic measures and deciding whether to extend birth hospitalization than screening for chronic opioid exposure alone.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Respiratory Arrest in a Late Preterm Infant Presenting for a 2-Week Well-Visit.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-02-26 DOI: 10.1542/peds.2024-070223
Daniel Hershey, Michael R Wilson, Richard D Goldstein
{"title":"Respiratory Arrest in a Late Preterm Infant Presenting for a 2-Week Well-Visit.","authors":"Daniel Hershey, Michael R Wilson, Richard D Goldstein","doi":"10.1542/peds.2024-070223","DOIUrl":"https://doi.org/10.1542/peds.2024-070223","url":null,"abstract":"","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Thinking More About Less: A Healthcare System for Lower-Acuity Infants.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-02-21 DOI: 10.1542/peds.2024-069555
Elizabeth G Salazar, Sara C Handley, Scott A Lorch
{"title":"Thinking More About Less: A Healthcare System for Lower-Acuity Infants.","authors":"Elizabeth G Salazar, Sara C Handley, Scott A Lorch","doi":"10.1542/peds.2024-069555","DOIUrl":"https://doi.org/10.1542/peds.2024-069555","url":null,"abstract":"","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pediatric Cholecystectomy Case Volume and Complexity Following the COVID-19 Pandemic.
IF 6.2 2区 医学 Q1 PEDIATRICS Pub Date : 2025-02-21 DOI: 10.1542/peds.2024-068065
Olivia A Keane, Shadassa Ourshalimian, Romeo Ignacio, Shannon Acker, Aaron Jensen, Katrine Lofberg, Claudia Mueller, Benjamin E Padilla, Samir Pandya, David H Rothstein, Katie W Russell, Caitlin Smith, MaKayla O'Guinn, Madeleine Ing, Gretchen Floan Sachs, Alexandra Highet, Stephanie E Iantorno, Lauren R Templeton, Brielle Ochoa, Utsav M Patwardhan, Alyssa Peace, Marisa E Schwab, Tina H Tran, Lorraine I Kelley-Quon

Background and objectives: Historically, cholecystectomy was infrequently performed in children. Lifestyle changes, delays in health care access, and increases in childhood obesity occurred during the COVID-19 pandemic. The impact of these shifts on need for cholecystectomy are poorly understood. We evaluate trends in cholecystectomy case volume among children during the COVID-19 pandemic.

Methods: A multi-institutional retrospective cohort study was conducted for children ages 18 years and younger who underwent cholecystectomy from January 1, 2016, to July 31, 2022, at 10 children's hospitals. Differences in cholecystectomy case mix and volume before and during the pandemic were identified using bivariate comparisons and interrupted time series analysis.

Results: Overall, 4282 children were identified: 2122 before the pandemic and 2160 during the pandemic. Most were female (74.2%) with a median age of 15 years (IQR, 13.0-16.0 years). The proportion of Hispanic (55.0% vs 60.1%; P = .01) patients, body mass index (BMI) (26.0 vs 27.1; P < .001), and obesity (BMI > 30) (30.8% vs 37.4%; P < .001) increased during the pandemic. Predicted monthly case volume increased from 40 to 100 during the pandemic. Patients transferred from an outside hospital increased (21.3% vs 28.5%; P < .001). Significant increases in acute cholecystitis (12.2% vs 17.3%; P < .001), choledocholithiasis (12.8% vs 16.5%; P = .001), gallstone pancreatitis (10.6% vs 12.4%; P = .064), and chronic cholecystitis (1.4% vs 3.2%; P < .001) also occurred. On interrupted time series analysis, change in month-to-month case count significantly increased during the pandemic (Figure 1; P < .001), which persisted after exclusion of transferred patients.

Conclusions: Pediatric cholecystectomy case volume and complexity increased during the COVID-19 pandemic. These findings may be secondary to changes in childhood health, transfer patterns, and shifts in access, highlighting an increased health care burden on children's hospitals.

背景和目的:历史上,儿童很少接受胆囊切除术。在 COVID-19 大流行期间,生活方式发生了改变,医疗保健服务延迟,儿童肥胖症增加。人们对这些变化对胆囊切除术需求的影响知之甚少。我们评估了 COVID-19 流行期间儿童胆囊切除术病例量的变化趋势:我们对 2016 年 1 月 1 日至 2022 年 7 月 31 日期间在 10 家儿童医院接受胆囊切除术的 18 岁及以下儿童进行了一项多机构回顾性队列研究。通过双变量比较和间断时间序列分析,确定了大流行之前和期间胆囊切除术病例组合和数量的差异:结果:共发现 4282 名儿童:大流行前为 2122 例,大流行期间为 2160 例。大部分为女性(74.2%),年龄中位数为 15 岁(IQR,13.0-16.0 岁)。西班牙裔患者的比例(55.0% vs 60.1%;P = .01)、体重指数(BMI)(26.0 vs 27.1;P 30)(30.8% vs 37.4%;P 结论:小儿胆囊切除术病例中,女性患者的比例较高:在 COVID-19 大流行期间,小儿胆囊切除术的病例量和复杂性都有所增加。这些发现可能与儿童健康状况的变化、转院模式和就医途径的转变有关,凸显了儿童医院医疗负担的加重。
{"title":"Pediatric Cholecystectomy Case Volume and Complexity Following the COVID-19 Pandemic.","authors":"Olivia A Keane, Shadassa Ourshalimian, Romeo Ignacio, Shannon Acker, Aaron Jensen, Katrine Lofberg, Claudia Mueller, Benjamin E Padilla, Samir Pandya, David H Rothstein, Katie W Russell, Caitlin Smith, MaKayla O'Guinn, Madeleine Ing, Gretchen Floan Sachs, Alexandra Highet, Stephanie E Iantorno, Lauren R Templeton, Brielle Ochoa, Utsav M Patwardhan, Alyssa Peace, Marisa E Schwab, Tina H Tran, Lorraine I Kelley-Quon","doi":"10.1542/peds.2024-068065","DOIUrl":"https://doi.org/10.1542/peds.2024-068065","url":null,"abstract":"<p><strong>Background and objectives: </strong>Historically, cholecystectomy was infrequently performed in children. Lifestyle changes, delays in health care access, and increases in childhood obesity occurred during the COVID-19 pandemic. The impact of these shifts on need for cholecystectomy are poorly understood. We evaluate trends in cholecystectomy case volume among children during the COVID-19 pandemic.</p><p><strong>Methods: </strong>A multi-institutional retrospective cohort study was conducted for children ages 18 years and younger who underwent cholecystectomy from January 1, 2016, to July 31, 2022, at 10 children's hospitals. Differences in cholecystectomy case mix and volume before and during the pandemic were identified using bivariate comparisons and interrupted time series analysis.</p><p><strong>Results: </strong>Overall, 4282 children were identified: 2122 before the pandemic and 2160 during the pandemic. Most were female (74.2%) with a median age of 15 years (IQR, 13.0-16.0 years). The proportion of Hispanic (55.0% vs 60.1%; P = .01) patients, body mass index (BMI) (26.0 vs 27.1; P < .001), and obesity (BMI > 30) (30.8% vs 37.4%; P < .001) increased during the pandemic. Predicted monthly case volume increased from 40 to 100 during the pandemic. Patients transferred from an outside hospital increased (21.3% vs 28.5%; P < .001). Significant increases in acute cholecystitis (12.2% vs 17.3%; P < .001), choledocholithiasis (12.8% vs 16.5%; P = .001), gallstone pancreatitis (10.6% vs 12.4%; P = .064), and chronic cholecystitis (1.4% vs 3.2%; P < .001) also occurred. On interrupted time series analysis, change in month-to-month case count significantly increased during the pandemic (Figure 1; P < .001), which persisted after exclusion of transferred patients.</p><p><strong>Conclusions: </strong>Pediatric cholecystectomy case volume and complexity increased during the COVID-19 pandemic. These findings may be secondary to changes in childhood health, transfer patterns, and shifts in access, highlighting an increased health care burden on children's hospitals.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Pediatrics
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1