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Full-Text Articles in Pediatrics

Impact Of Michigan Public Act 246 On Opioid Prescribing For Pediatric Surgical Patients, Madison Saunders, Pavan Brahmamdam May 2025

Impact Of Michigan Public Act 246 On Opioid Prescribing For Pediatric Surgical Patients, Madison Saunders, Pavan Brahmamdam

Posters

1. Opioid misuse is an epidemic in the U.S. affecting 3.1% of pediatric patients.2,3.

2. Most common way adolescence obtain access to opioids is by their own prescription or a family member. 3,4 3.

3. In December 2017, Michigan enacted Public Act 246 (P246) in an attempt to address rising opioid misuse.

4. P246 states that as of June 1, 2018, a prescriber of a controlled substance must discuss the risks of opioid usage minor and the minor’s parent or guardian and sign a consent form.


The Burden Of Care: Understanding Burnout Among Pediatric Healthcare Workers, Navya Khandavalli May 2025

The Burden Of Care: Understanding Burnout Among Pediatric Healthcare Workers, Navya Khandavalli

Theses/Capstones/Creative Projects

Burnout among pediatric healthcare professionals is a growing concern that impacts both employee well-being and the overall quality of patient care. The aim of this study is to analyze the definition of burnout and how healthcare organizations can implore strategies to help improve the mental and physical well-being of their staff. Analysis was done through a survey administered to healthcare employees recruited from pediatric clinics, the neonatal ICU, pediatric research, and pediatric rehabilitation facilities. Findings from the methods found that burnout is often defined as prolonged occupational stress in an individual and are often characterized by symptoms of emotional exhaustion, …


Bisphosphonate Treatment In Pediatric Patients With Rare Ovarian Malignancy And Hypercalcemia: A Case Series, Seth Lamb, Samhita Bhattarai, Jennifer Boyd May 2025

Bisphosphonate Treatment In Pediatric Patients With Rare Ovarian Malignancy And Hypercalcemia: A Case Series, Seth Lamb, Samhita Bhattarai, Jennifer Boyd

Posters

Objective: To describe the presentation, management, and outcomes of severe hypercalcemia in two adolescent females secondary to ovarian malignancy. Methods: The case series includes two adolescent female patients, aged 11 and 16, diagnosed with rare ovarian malignancies and associated hypercalcemia. The 11-year-old female was diagnosed with small cell carcinoma of ovary while the 16-year-old was diagnosed with dysgerminoma. Both patients presented with abdominal pain, nausea and constipation. The 11-year-old received zoledronic acid while the 16-year-old received pamidronate. Serum calcium level, symptoms and adverse effects were monitored before and after both medications. Results: Both patients presented with severe hypercalcemia. The 11-year …


Physician Use Of Progesterone In Transgender Adolescents: A Survey, Samhita Bhattarai, Michelle Knoll May 2025

Physician Use Of Progesterone In Transgender Adolescents: A Survey, Samhita Bhattarai, Michelle Knoll

Posters

Objectives To evaluate the current perspective and clinical practices of physicians regarding the use of synthetic progestins as an adjunct to estrogen therapy in transfeminine adolescents. The survey focuses on perceived benefits, risks and overall efficacy in gender affirming hormone therapy. Methods A cross sectional survey was conducted among physicians who care for transfeminine patients. The survey included questions regarding their specialty, practice setting, age range of patients. Data was also collected regarding their indication for use, perceived benefits (e.g. breast development) and rationale if not using progestins for this purpose. Results Of 110 physicians who participated in the survey, …


Implementation Of An Opioid Free Pediatric Hernia Repair Protocol, Corey Shafer, Antonela Muca, Randy Hilleary, Kristin Lemarbe, Diane Studzinsk, Kaveh Aslani, Nathan Novotny, Pavan Brahmamdam, Begum Akay May 2025

Implementation Of An Opioid Free Pediatric Hernia Repair Protocol, Corey Shafer, Antonela Muca, Randy Hilleary, Kristin Lemarbe, Diane Studzinsk, Kaveh Aslani, Nathan Novotny, Pavan Brahmamdam, Begum Akay

Posters

Surgery most often provides children with their first exposure to opioids which may lead to misuse and overuse. Protocolizing pain management perioperatively can reduce opioid exposure in children while still providing adequate pain management.


Association Of Delayed Asthma Diagnosis With Asthma Exacerbations In Children, Chung-Il Wi, Euijung Ryu, Katherine S King, Jung Hyun Kwon, Joshua T Bublitz, Miguel Park, Sergio E Chiarella, Jason D Greenwood, Thanai Pongdee, Lynnea Myers, Björn Nordlund, Sunghwan Sohn, Elham Sagheb, Bhavani Singh Agnikula Kshatriya, Dave Watson, Hongfang Liu, Beverley J Sheares, Carla M Davis, Wade Schulz, Young J Juhn May 2025

Association Of Delayed Asthma Diagnosis With Asthma Exacerbations In Children, Chung-Il Wi, Euijung Ryu, Katherine S King, Jung Hyun Kwon, Joshua T Bublitz, Miguel Park, Sergio E Chiarella, Jason D Greenwood, Thanai Pongdee, Lynnea Myers, Björn Nordlund, Sunghwan Sohn, Elham Sagheb, Bhavani Singh Agnikula Kshatriya, Dave Watson, Hongfang Liu, Beverley J Sheares, Carla M Davis, Wade Schulz, Young J Juhn

Faculty, Staff and Student Publications

Background: There is a significant delay between symptom onset and diagnosis of childhood asthma, but the impact of this delay on asthma outcomes has not been well understood.

Objectives: We sought to study the association of delayed diagnosis of asthma with asthma exacerbations (AEs) in children.

Methods: Using the Mayo Clinic birth cohort, we identified children with a diagnosis of asthma from electronic health records. We defined onset date as the date when subjects first met predetermined asthma criteria ascertained by an electronic health records-based natural language processing algorithm. Delay in diagnosis (DD) was defined as first diagnosis >30 days …


Pelvic Inflammatory Disease, Children's Mercy Kansas City May 2025

Pelvic Inflammatory Disease, Children's Mercy Kansas City

Clinical Pathways

No abstract provided.


Increasing Incentive Spirometry Use In Patients With Sickle Cell Disease Admitted To Cmh, Juan Nario Ramirez, Alexandra Prosser-Dombrowski, Thomas R. Cochran, Joel Thompson May 2025

Increasing Incentive Spirometry Use In Patients With Sickle Cell Disease Admitted To Cmh, Juan Nario Ramirez, Alexandra Prosser-Dombrowski, Thomas R. Cochran, Joel Thompson

Posters

Acute chest syndrome is one of the leading causes of morbidity and mortality in patients with sickle cell disease. The National Heart, Lung, and Blood Institute (NHLBI) recommends that patients with sickle cell disease perform ten breaths of incentive spirometry (IS) every two hours while awake to prevent development of acute chest syndrome. By not meeting these guidelines, patients are more likely to develop this potentially life-threatening acute complication. To increase the use of IS in patients with sickle cell disease admitted to the hospital for vaso-occlusive pain. Patients were identified and IS occurrences were measured via review of electronic …


Measles, Children's Mercy Kansas City May 2025

Measles, Children's Mercy Kansas City

Clinical Pathways

No abstract provided.


Impact Of Michigan Public Act 246 On Opioid Prescribing After Pediatric Surgery, Madison Saunders, Nathan Novotny, Anthony Stallion, Begum Akay, Pavan Brahmamdam, Ryan T. Davis May 2025

Impact Of Michigan Public Act 246 On Opioid Prescribing After Pediatric Surgery, Madison Saunders, Nathan Novotny, Anthony Stallion, Begum Akay, Pavan Brahmamdam, Ryan T. Davis

Conference Presentation Abstracts

Abstract: Background: In December 2017, Michigan enacted Public Act 246(P246) to address rising opioid misuse. P246 states that, as of June 1, 2018, a prescriber of a controlled substance must discuss the risks of opioid addiction, overdose, and the dangers of taking opioids with benzodiazepine, alcohol or any other nervous system depressant with the minor and the minor’s parent or guardian. This study aims to evaluate the impact of this legislation by comparing opioid morphine milligram equivalents (MME) prescribed to pediatric patients undergoing common general, urological, and ENT surgeries before and after June 1, 2018. Methods: A single-center, retrospective chart …


The Role Of Responsive Feeding In Childhood Development And Clinical Implications: A Comprehensive Literature Review, Alexander Burbach May 2025

The Role Of Responsive Feeding In Childhood Development And Clinical Implications: A Comprehensive Literature Review, Alexander Burbach

Capstone Experience: Master of Public Health

Responsive feeding refers to caregiver-infant feeding interactions that encourage healthy eating behaviors and support the child’s autonomy by responding to their hunger and satiety cues. Responsive feeding supports healthy early childhood development, influencing self-regulation in eating behaviors and long-term health outcomes, particularly in obesity prevention. A comprehensive literature review was conducted to examine the impact of responsive feeding practices on childhood development in the United States and its clinical implications. The objectives were to explore the role of parental feeding practices in shaping childhood eating behaviors, understand the relationship between responsive feeding and obesity, and determine literature daps. Articles for …


Safety And Utility Of Robotics In Pediatric Surgery: Implementation, Luke J. Man, Kristin Lemarbe, Nathan Novotny, Anthony Stallion, Begum Akay, Pavan Brahmamdam May 2025

Safety And Utility Of Robotics In Pediatric Surgery: Implementation, Luke J. Man, Kristin Lemarbe, Nathan Novotny, Anthony Stallion, Begum Akay, Pavan Brahmamdam

Posters

• Minimally invasive laparoscopic surgery is considered standard of care for adult and pediatric patients .

• Robotic surgery (RS) for adult patients has been widely adopted due to superior ergonomics, visualization, depth perception, and access to deeper anatomical structures2,3.

• Historically, RS is associated with longer operative times, higher cost, and lacks haptic feedback1,2.

• RS has had inconsistent adoption in the pediatric surgery community2.


Improving Treatment For Infant Perianal Abscesses, Artem Dadamyan, Nathan Novotny, Ngan Nguyen May 2025

Improving Treatment For Infant Perianal Abscesses, Artem Dadamyan, Nathan Novotny, Ngan Nguyen

Posters

Perianal abscesses: • Tender masses located at the anal verge, typically in the 3 o’clock and 9 o’clock positions1

• Develop due to infection in abnormally deep crypts of Morgagni 1

• If left untreated, can extend into the ischioanal space or intersphincteric space since these areas are continuous with the perianal space.2

• Some may develop into fistula in ano, which can be difficult to treat3 Treatment:

• The standard has always been incision and drainage (I&D), but non-invasive management of Sitz baths is increasingly being used.


Surgical Site Infection Bundle For Babies: Preliminary Data, Cullen Woodley, John Nida, Alexis Lonjin, Katelyn Ward, Diane Studzinski, Begum Akay May 2025

Surgical Site Infection Bundle For Babies: Preliminary Data, Cullen Woodley, John Nida, Alexis Lonjin, Katelyn Ward, Diane Studzinski, Begum Akay

Posters

Surgical Site Infections (SSIs) are infections that occur in or around the area where a surgery was recently performed. They are estimated to account for 20% of all healthcare associated infection, and lead to an increase in morbidity and mortality. Perioperative care bundles show promise in reducing SSIs in adults but are not often used in neonatal surgery. Infections in babies after surgery are less common than adults but carry significant morbidity in a fragile patient.


Us Infant Formulas Contain Primarily Added Sugars: An Analysis Of Infant Formulas On The Us Market, Audrey R. Rips-Goodwin, Daiil Jun, Adrianne Griebel-Thompson, Kai Ling Kong, Tera L. Fazzino May 2025

Us Infant Formulas Contain Primarily Added Sugars: An Analysis Of Infant Formulas On The Us Market, Audrey R. Rips-Goodwin, Daiil Jun, Adrianne Griebel-Thompson, Kai Ling Kong, Tera L. Fazzino

Manuscripts, Articles, Book Chapters and Other Papers

Added sugar consumption is contraindicated for infants <  2 years old; however added sugars are present in many US infant formulas. We examined whether US formulas contain primarily added sugars, or whether formulas contain primarily naturally occurring lactose (the sugar in human milk). Data were obtained from the Nutrition Data System for Research and included formulas available on the US market in 2022 (N = 73). Formulas were categorized as: standard (n = 31), gentle (n = 27), and lactose-free (n = 15). Differences across formulas were examined using Bayesian modeling. The median percent added sugars were high in standard (M=59.7 %; IQR=22.0), gentle (M=85.0 %; IQR=39.5), and lactose-free formulas (M=90.0 %; IQR=54.3). Gentle formulas had significantly lower proportional lactose (OR=0.22, 95 % HDI=[0.11,0.44], pd=99.3 %) and > 2 fold higher proportional added sugars compared to standard formulas (ORs=2.11–2.57, HDI>0, pd=99.1–99.99 …


Changes In Adequacy Of Splanchnic Oxygen Delivery And Splanchnic Artery Doppler After Bolus Feedings In Infants: A Systematic Review And Meta-Analysis, Rohit S Loomba, Saloni P Sheth, Joshua Wong, Megan Davis, Juan S Farias, Enrique G Villarreal, Saul Flores May 2025

Changes In Adequacy Of Splanchnic Oxygen Delivery And Splanchnic Artery Doppler After Bolus Feedings In Infants: A Systematic Review And Meta-Analysis, Rohit S Loomba, Saloni P Sheth, Joshua Wong, Megan Davis, Juan S Farias, Enrique G Villarreal, Saul Flores

Faculty, Staff and Students Publications

Background: Current practice regarding timing of feed initiation and feed tolerance largely relies on anecdotal practice and protocols. This study aims to provide an objective measure to guide clinical practice by analyzing changes in splanchnic regional oxygen saturation and Doppler patterns with feeds.

Methods: A systematic review was performed. Inclusion criteria were: 1) patients under 1 year of age; 2) splanchnic regional oxygen saturation with near infrared spectroscopy before and after feeds or mesenteric Doppler findings before and after feeds; and 3) clinical parameters must have been presented as either mean and standard deviation or median and range. Endpoints of …


Discharge Practice Variability In Pediatric Chronic Home Invasive Ventilation, Guillermo Beltran-Ale, Ryne Simpson, Terri Magruder, Ajay S Kasi, Amit Agarwal, Jake A Kaslow May 2025

Discharge Practice Variability In Pediatric Chronic Home Invasive Ventilation, Guillermo Beltran-Ale, Ryne Simpson, Terri Magruder, Ajay S Kasi, Amit Agarwal, Jake A Kaslow

Faculty, Staff and Students Publications

Introduction: The Pediatric Mechanical Ventilation Society is a collaboration of pediatric pulmonologists with a focus on pediatric chronic home invasive ventilation (PCHIV). Since the initial discharge on PCHIV is not always directed by pediatric pulmonologists, we sought to understand how this variability between centers impact adherence to American Thoracic Society (ATS) guidelines for PCHIV.

Methods: A survey was distributed to pediatric pulmonologists across multiple platforms inquiring about discharging practices for PCHIV and adherence to six of the nine ATS recommendations for PCHIV. Two subgroups were created based on common practices - discharge by pediatric pulmonologists from a non-ICU unit (pulmonary …


Digital Interventions For Suicide Prevention, Sean K Burr, Miao Yu, Danny Clark, Dana Alonzo, Robin E Gearing May 2025

Digital Interventions For Suicide Prevention, Sean K Burr, Miao Yu, Danny Clark, Dana Alonzo, Robin E Gearing

Faculty, Staff and Students Publications

Background: Digital-based mobile interventions hold significant promise in preventing suicide. Although mixed, some evidence suggests these interventions are effective and capable of overcoming barriers such as cost and stigma. Aim(s): This review aimed to determine the effectiveness of digital interventions designed to address suicidal ideation and behaviors and the impacts of age, gender, and control group type on these outcomes.

Methods: Databases were searched for randomized controlled trials (RCTs) on digital suicide interventions (apps/online programs) published before January 1, 2022. Data were analyzed using a random-effects model in Stata 17.

Results: The search identified 4,317 articles, and 16 were included. …


Feasibility And Acceptability Of The Team Pilot Trial With African American And Latino Families, Ashley M Butler, Marisa E Hilliard, Krystal Christopher, Marissa Baudino, Charles Minard, Lefkothea Karaviti May 2025

Feasibility And Acceptability Of The Team Pilot Trial With African American And Latino Families, Ashley M Butler, Marisa E Hilliard, Krystal Christopher, Marissa Baudino, Charles Minard, Lefkothea Karaviti

Faculty, Staff and Students Publications

Objective: We adapted the empirically supported Family Teamwork intervention protocol to support collaborative parent involvement in type 1 diabetes (T1D) management among African American and Latino parents of children with T1D. This randomized pilot study aimed to evaluate feasibility and acceptability of the Type 1 Diabetes Empowerment and Management (TEAM) intervention.

Methods: African American and Latino parents (n = 59; 65% recruitment rate) of youth (ages 5-10 years, M = 8.9 ± 1.6 years; 59% female, M hemoglobin A1c 9.0% ± 1.9%) with diabetes duration of ≥1 year and who were fluent in English and not planning to leave the …


Digital Twins, Synthetic Patient Data, And In-Silico Trials: Can They Empower Paediatric Clinical Trials?, Mohan Pammi, Prakesh S Shah, Liu K Yang, Joseph Hagan, Nima Aghaeepour, Josef Neu May 2025

Digital Twins, Synthetic Patient Data, And In-Silico Trials: Can They Empower Paediatric Clinical Trials?, Mohan Pammi, Prakesh S Shah, Liu K Yang, Joseph Hagan, Nima Aghaeepour, Josef Neu

Faculty, Staff and Students Publications

Randomised controlled trials are the gold standard to assess the effectiveness and safety of clinical interventions; however, many paediatric trials are discontinued early due to challenges in patient enrolment. Hence, most paediatric clinical trials suffer from lack of adequate power. Additionally, trials are expensive and might expose patients to unproven therapies. Alternatives to overcome these issues using virtual patient data—namely, digital twins, synthetic patient data, and in-silico trials—are now possible due to rapid advances in digital health-care tools and interventions. However, such digital innovations have been rarely used in paediatric trials. In this Viewpoint, we propose using virtual patient data …


Early Prediction Of Mortality And Morbidities In Vlbw Preterm Neonates Using Machine Learning, Chi-Hung Shu, Rema Zebda, Camilo Espinosa, Jonathan Reiss, Anne Debuyserie, Kristina Reber, Nima Aghaeepour, Mohan Pammi May 2025

Early Prediction Of Mortality And Morbidities In Vlbw Preterm Neonates Using Machine Learning, Chi-Hung Shu, Rema Zebda, Camilo Espinosa, Jonathan Reiss, Anne Debuyserie, Kristina Reber, Nima Aghaeepour, Mohan Pammi

Faculty, Staff and Students Publications

Background: Predicting mortality and specific morbidities before they occur may allow for interventions that may improve health trajectories.

Hypothesis: Integrating key maternal and postnatal infant variables in the first 2 weeks of age into machine learning (ML) algorithms will reliably predict survival and specific morbidities in VLBW preterm infants.

Methods: ML algorithms were developed to integrate 47 features for predicting mortality, bronchopulmonary dysplasia (BPD), neonatal sepsis, necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), cystic periventricular leukomalacia (PVL), and retinopathy of prematurity (ROP). A retrospective cohort (n = 3341) was used to train and validate the models with a repeated 10-fold cross-validation …


Reducing Diabetic Ketoacidosis Incidence In Children With Type 1 Diabetes Through Wraparound Services At Texas Children's Hospital: The Reach Program, Selorm Dei-Tutu, Fulfilled Ighalo, Pavandeep Rakhra, Rebecca Butler, Amelia Martinez, Kelly Timmons, Don Buckingham, David D Schwartz, Meghan Craven May 2025

Reducing Diabetic Ketoacidosis Incidence In Children With Type 1 Diabetes Through Wraparound Services At Texas Children's Hospital: The Reach Program, Selorm Dei-Tutu, Fulfilled Ighalo, Pavandeep Rakhra, Rebecca Butler, Amelia Martinez, Kelly Timmons, Don Buckingham, David D Schwartz, Meghan Craven

Faculty, Staff and Students Publications

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of


Treatment Of Rapid Recurrence Of Severe Steatosis With Combined Glucagon-Like Peptide-1 Agonist And Growth Hormone Therapy In A Pediatric Patient Transplanted For Metabolic Dysfunction-Associated Steatohepatitis Cirrhosis In The Setting Of Hypopituitarism, Stephanie R Saaybi, Henry Shiau, Goo Lee, Babak John Orandi, Luz Helena Gutierrez Sanchez May 2025

Treatment Of Rapid Recurrence Of Severe Steatosis With Combined Glucagon-Like Peptide-1 Agonist And Growth Hormone Therapy In A Pediatric Patient Transplanted For Metabolic Dysfunction-Associated Steatohepatitis Cirrhosis In The Setting Of Hypopituitarism, Stephanie R Saaybi, Henry Shiau, Goo Lee, Babak John Orandi, Luz Helena Gutierrez Sanchez

Faculty, Staff and Students Publications

The association between hypopituitarism and metabolic dysfunction-associated steatotic liver disease is increasingly recognized, although data about therapies targeting recurrence posttransplant is limited. An 8-year-old with hypopituitarism-associated metabolic dysfunction-associated steatotic liver disease underwent a liver transplant due to rapid progression of metabolic dysfunction-associated steatohepatitis. Hepatosteatosis recurred within weeks. Her therapeutic plan included a glucagon-like peptide-1 agonist and growth hormone replacement. Her transaminases normalized in 2.5 months, and her macrosteatosis significantly improved on the 1-year surveillance biopsy. This case highlights one of the youngest reported children with hypopituitarism to have undergone transplantation for rapidly progressing metabolic dysfunction-associated steatohepatitis and its recurrence post-operatively. …


Pediatric Predictive Artificial Intelligence Implemented In Clinical Practice From 2010 To 2021: A Systematic Review, Swaminathan Kandaswamy, Lindsey A Knake, Adam C Dziorny, Sean M Hernandez, Allison B Mccoy, Lauren M Hess, Evan Orenstein, Mia S White, Eric S Kirkendall, Matthew J Molloy, Philip A Hagedorn, Naveen Muthu, Avinash Murugan, Jonathan M Beus, Mark Mai, Brooke Luo, Juan D Chaparro May 2025

Pediatric Predictive Artificial Intelligence Implemented In Clinical Practice From 2010 To 2021: A Systematic Review, Swaminathan Kandaswamy, Lindsey A Knake, Adam C Dziorny, Sean M Hernandez, Allison B Mccoy, Lauren M Hess, Evan Orenstein, Mia S White, Eric S Kirkendall, Matthew J Molloy, Philip A Hagedorn, Naveen Muthu, Avinash Murugan, Jonathan M Beus, Mark Mai, Brooke Luo, Juan D Chaparro

Faculty, Staff and Students Publications

To review pediatric artificial intelligence (AI) implementation studies from 2010 to 2021 and analyze reported performance measures.We searched PubMed/Medline, Embase CINHAL, Cochrane Library CENTRAL, IEEE, and Web of Science with controlled vocabulary. Inclusion criteria: AI intervention in a pediatric clinical setting that learns from data (i.e., data-driven, as opposed to rule-based) and takes actions to make patient-specific recommendations; published between 01/2010 and 10/2021; must have agency (AI must provide guidance that affects clinical care, not merely running in the background). We extracted study characteristics, target users, implementation setting, time span, and performance measures.Of 126 articles reviewed as full text, 17 …


Efficacy And Safety Of Epicutaneous Immunotherapy In Peanut-Allergic Toddlers: Open-Label Extension To Epitope, Matthew Greenhawt, Deborah Albright, Sara Anvari, Nicolette Arends, Peter D Arkwright, Philippe Bégin, Katharina Blümchen, Terri Brown-Whitehorn, Heather Cassell, Edmond S Chan, Christina E Ciaccio, Antoine Deschildre, Amandine Divaret-Chauveau, Stacy Dorris, Morna Dorsey, George Du Toit, Thomas Eiwegger, Michel Erlewyn-Lajeunesse, David M Fleischer, Lara S Ford, Maria Garcia-Lloret, Jonathan O'B Hourihane, Nicola Jay, Stacie M Jones, Edwin H Kim, Kirsten Kloepfer, Stephanie Leonard, Guillaume Lezmi, Jay Lieberman, Jeanne Lomas, Melanie Makhija, Michael O'Sullivan, Christopher Parrish, Jane Peake, Kirsten P Perrett, Daniel Petroni, Jacqueline A Pongracic, Patrick Quinn, Rachel G Robison, Georgiana Sanders, Lynda Schneider, Hemant Sharma, Sayantani B Sindher, Juan Trujillo, Paul J Turner, Katherine Tuttle, Julia Upton, Pooja Varshney, Brian P Vickery, Christian Vogelberg, Brynn Wainstein, Julie Wang, Robert Wood, Katharine J Bee, Dianne E Campbell, Todd D Green, Rihab Rouissi, Henry T Bahnson, Timothée Bois, Hugh A Sampson, A Wesley Burks May 2025

Efficacy And Safety Of Epicutaneous Immunotherapy In Peanut-Allergic Toddlers: Open-Label Extension To Epitope, Matthew Greenhawt, Deborah Albright, Sara Anvari, Nicolette Arends, Peter D Arkwright, Philippe Bégin, Katharina Blümchen, Terri Brown-Whitehorn, Heather Cassell, Edmond S Chan, Christina E Ciaccio, Antoine Deschildre, Amandine Divaret-Chauveau, Stacy Dorris, Morna Dorsey, George Du Toit, Thomas Eiwegger, Michel Erlewyn-Lajeunesse, David M Fleischer, Lara S Ford, Maria Garcia-Lloret, Jonathan O'B Hourihane, Nicola Jay, Stacie M Jones, Edwin H Kim, Kirsten Kloepfer, Stephanie Leonard, Guillaume Lezmi, Jay Lieberman, Jeanne Lomas, Melanie Makhija, Michael O'Sullivan, Christopher Parrish, Jane Peake, Kirsten P Perrett, Daniel Petroni, Jacqueline A Pongracic, Patrick Quinn, Rachel G Robison, Georgiana Sanders, Lynda Schneider, Hemant Sharma, Sayantani B Sindher, Juan Trujillo, Paul J Turner, Katherine Tuttle, Julia Upton, Pooja Varshney, Brian P Vickery, Christian Vogelberg, Brynn Wainstein, Julie Wang, Robert Wood, Katharine J Bee, Dianne E Campbell, Todd D Green, Rihab Rouissi, Henry T Bahnson, Timothée Bois, Hugh A Sampson, A Wesley Burks

Faculty, Staff and Students Publications

Background: The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN patch containing 250 μg of peanut protein (VP250), previously reported significant treatment response versus placebo in peanut-allergic toddlers aged 1 through 3 years.

Objective: To assess the interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.

Methods: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results.

Results: A total …


Long-Term Safety Of Epicutaneous Immunotherapy In Peanut-Allergic Children: An Open-Label Active Treatment (Realise Study), Jacqueline A Pongracic, Rémi Gagnon, Gordon Sussman, Dareen Siri, Roxanne C Oriel, Terri F Brown-Whitehorn, Sara Anvari, William E Berger, J Andrew Bird, Edmond S Chan, R Sharon Chinthrajah, Hey J Chong, Stanley M Fineman, David M Fleischer, Erika Gonzalez-Reyes, Edwin H Kim, Bruce J Lanser, Andrew Macginnitie, Hemalini Mehta, Daniel Petroni, Ned Rupp, Lynda C Schneider, Amy M Scurlock, Lawrence D Sher, Wayne G Shreffler, Sayantani B Sindher, Robert Wood, William H Yang, Hugh A Sampson, Timothée Bois, Todd D Green, Dianne E Campbell, Katharine J Bee, Philippe Bégin May 2025

Long-Term Safety Of Epicutaneous Immunotherapy In Peanut-Allergic Children: An Open-Label Active Treatment (Realise Study), Jacqueline A Pongracic, Rémi Gagnon, Gordon Sussman, Dareen Siri, Roxanne C Oriel, Terri F Brown-Whitehorn, Sara Anvari, William E Berger, J Andrew Bird, Edmond S Chan, R Sharon Chinthrajah, Hey J Chong, Stanley M Fineman, David M Fleischer, Erika Gonzalez-Reyes, Edwin H Kim, Bruce J Lanser, Andrew Macginnitie, Hemalini Mehta, Daniel Petroni, Ned Rupp, Lynda C Schneider, Amy M Scurlock, Lawrence D Sher, Wayne G Shreffler, Sayantani B Sindher, Robert Wood, William H Yang, Hugh A Sampson, Timothée Bois, Todd D Green, Dianne E Campbell, Katharine J Bee, Philippe Bégin

Faculty, Staff and Students Publications

Background: Owing to limited treatment options for peanut allergy, patients remain at risk for allergic reactions due to accidental exposure. Epicutaneous immunotherapy (EPIT) is a novel treatment being investigated for peanut allergy.

Objective: This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial.

Methods: REALISE was a phase 3 trial in peanut-allergic children aged 4 through 11 years that included a 6-month, randomized, double-blind, placebo-controlled treatment phase, followed by an open-label, single-arm, active treatment period for up to 36 months.

Results: …


Multicenter Food Protein-Induced Enterocolitis Syndrome (Fpies) Data Collection: Leveraging A Redcap Fpies Registry For Improved Clinical Outcomes, Ankona Banerjee, J Andrew Bird, Amy M Scurlock, Pooja Varshney, Elizabeth Brunner, Ankur Bhagwath, Benjamin Daines, Malika Gupta, Tevon Hood, Maria Lee, Michelle Lee, Emily Seminara, Rachel Smith, Gail Tan, Marion Jose Valladares, Hiral Waghela, Duc T Nguyen, Sara Anvari May 2025

Multicenter Food Protein-Induced Enterocolitis Syndrome (Fpies) Data Collection: Leveraging A Redcap Fpies Registry For Improved Clinical Outcomes, Ankona Banerjee, J Andrew Bird, Amy M Scurlock, Pooja Varshney, Elizabeth Brunner, Ankur Bhagwath, Benjamin Daines, Malika Gupta, Tevon Hood, Maria Lee, Michelle Lee, Emily Seminara, Rachel Smith, Gail Tan, Marion Jose Valladares, Hiral Waghela, Duc T Nguyen, Sara Anvari

Faculty, Staff and Students Publications

Background: Food protein-induced enterocolitis syndrome (FPIES) is a non-IgE-mediated food allergy typically presenting in infancy but has also been recognized in adults. FPIES is an allergic emergency due to severe vomiting occurring 1 to 4 hours after ingesting the causative food protein. Since the 2017 FPIES guidelines, no prospective data exist on the prevalence, incidence, and clinical characteristics of FPIES.

Objective: We established a multicenter FPIES registry to systematically collect clinical data and biospecimens on FPIES patients.

Methods: The FPIES registry is a US multicenter REDCap database collecting epidemiologic data to support the evolving FPIES landscape in relation to age …


Evaluating The Test-Negative Design For Covid-19 Vaccine Effectiveness Using Randomized Trial Data: A Secondary Cross-Protocol Analysis Of 5 Randomized Clinical Trials, Leah I B Andrews, M Elizabeth Halloran, Kathleen M Neuzil, Lars Van Der Laan, Yunda Huang, Jessica Andriesen, Mayur Patel, Leigh H Fisher, Holly Janes, Nadine Rouphael, Stephen R Walsh, Deborah A Theodore, Hong-Van Tieu, Magdalena Sobieszczyk, Hana M El Sahly, Lindsey R Baden, Ann R Falsey, Thomas B Campbell, Colleen F Kelley, Catherine Mary Healy, Lilly Immergluck, Benjamin Luft, Ian Hirsch, Guy De Bruyn, Carla Truyers, Frances Priddy, Kelsey M Sumner, Brendan Flannery, Dean Follmann, Peter B Gilbert, Covid-19 Prevention Network (Covpn) May 2025

Evaluating The Test-Negative Design For Covid-19 Vaccine Effectiveness Using Randomized Trial Data: A Secondary Cross-Protocol Analysis Of 5 Randomized Clinical Trials, Leah I B Andrews, M Elizabeth Halloran, Kathleen M Neuzil, Lars Van Der Laan, Yunda Huang, Jessica Andriesen, Mayur Patel, Leigh H Fisher, Holly Janes, Nadine Rouphael, Stephen R Walsh, Deborah A Theodore, Hong-Van Tieu, Magdalena Sobieszczyk, Hana M El Sahly, Lindsey R Baden, Ann R Falsey, Thomas B Campbell, Colleen F Kelley, Catherine Mary Healy, Lilly Immergluck, Benjamin Luft, Ian Hirsch, Guy De Bruyn, Carla Truyers, Frances Priddy, Kelsey M Sumner, Brendan Flannery, Dean Follmann, Peter B Gilbert, Covid-19 Prevention Network (Covpn)

Faculty, Staff and Students Publications

Importance: The test-negative design (TND) has been widely used to assess postmarketing COVID-19 vaccine effectiveness but requires further evaluation for this application.

Objective: To determine whether the TND reliably evaluates vaccine effectiveness against symptomatic COVID-19 using placebo-controlled vaccine efficacy randomized clinical trials (RCTs).

Design, setting, and participants: This secondary cross-protocol analysis constructed TND study datasets from study sites in 16 countries across 5 continents using the blinded phase cohorts of 5 harmonized phase 3 COVID-19 Prevention Network RCTs: COVE (Coronavirus Vaccine Efficacy and Safety), AZD1222, ENSEMBLE, PREVENT-19 (Prefusion Protein Subunit Vaccine Efficacy Novavax Trial COVID-19), and VAT00008. Participants included adults …


The Central Role Of Cytochrome P450 Reductase (Cpr) In Hyperoxic Lung Injury, Deven Narke, Bhagavatula Moorthy May 2025

The Central Role Of Cytochrome P450 Reductase (Cpr) In Hyperoxic Lung Injury, Deven Narke, Bhagavatula Moorthy

Faculty, Staff and Students Publications

Introduction: Hyperoxic lung injury results from excessive supplemental oxygen therapy in conditions such as bronchopulmonary dysplasia (BPD) in preterm infants and acute respiratory distress syndrome (ARDS) in adults. This review explores the role of cytochrome P450 reductase (CPR) in hyperoxic lung injury.

Areas covered: Hyperoxia induces the production of reactive oxygen species in excessive amounts, overwhelming the body's antioxidant defenses and exacerbating lung injury in ARDS/BPD. This review examines the differential roles of CPR-dependent enzymes in the context of hyperoxic lung injury. Additionally, we highlight the potential of targeting CPR to study mechanisms of lung injury and leverage gene-editing technologies …


Editorial: The Journal Of Pediatric Psychology Remains Committed To Advancing Pediatric Psychology Science, Avani C Modi, Kurt A Freeman, Cecelia Valrie, Marisa E Hilliard, Eleanor R Mackey, Katie A Devine, Susan Wood May 2025

Editorial: The Journal Of Pediatric Psychology Remains Committed To Advancing Pediatric Psychology Science, Avani C Modi, Kurt A Freeman, Cecelia Valrie, Marisa E Hilliard, Eleanor R Mackey, Katie A Devine, Susan Wood

Faculty, Staff and Students Publications

No abstract provided.