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. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

Articles

Those with inpatient food insecurity had an increased length of stay, as well as increased odds of readmission. 

Exploring associations of inpatient food insecurity and pediatric hospitalizations

In this analysis, the differences in adverse events resulting from JAKi among adults and children were evaluated. 

Comparing safety of JAK inhibitors between adolescent, adult patient

Infigratinib has also received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA. 

FDA grants Breakthrough Therapy to oral infigratinib for children with achondroplasia

Investigators found the association for higher BMI, increased obesity risk, and increased severe obesity risk. 

Low-food access in early life associated with higher subsequent child BMI, obesity risk

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One physician’s personal agenda is to help parents understand how their own history of dealing with stress affects how they bond with their child.

Attachment is the key to parent-child relationships

Recommendations and Outlook for Central Precocious Puberty

Video content above is prompted by the following:

Can you provide any recommendations on supporting patients navigating stigmas and social hardships associated with CPP?

Please provide any closing thoughts regarding your clinical experience with the management of CPP and your outlook of the future.

Experts offer recommendations for supporting central precocious puberty patients in managing the social stigma and challenges associated with their condition.

Video Series

Dupilumab treatment of children aged 6–11 years who have uncontrolled 

 led to diminished rates of exacerbation and lung function improvements for up to 2 years, according to recent findings.1

These conclusions were the result of new research conducted to assess the effectiveness and the safety of add-on dupilumab at an every 2 week dose of 200 mg. This was the largest dose cohort within both the VOYAGE and EXCURSION studies for children.

This study was led by Wanda Phipatanakul, MD, from the division of immunology at Boston Children's Hospital in Massachusetts. Phipatanakul and colleagues noted that there is prior evidence of dupilumab reducing childrens’ rates of severe exacerbations and improved lung function at 100 and 200 mg dupilumab doses, but not up to 2 years.2

“Given that dupilumab 200 mg is the only dose that can be prescribed to children (aged 6–11 years) in some countries, this post hoc analysis assesses dupilumab efficacy and safety in the cohort of children who received dupilumab 200 mg q2w up to 2 years throughout VOYAGE and EXCURSION,” Phipatanakul and colleagues wrote.1

The investigators enrolled 408 children in the 6-11 year age range in the VOYAGE study, designed as a phase 3, randomized, double-blind trial lasting 52 weeks and including those with clinician-diagnosed uncontrolled moderate-to-severe asthma. They were divided by weight to be treated either with placebo or with dupilumab 100 mg or 200 mg every 2 weeks (for subjects ≤30 kg and for those >30 kg, respectively).

Following the VOYAGE study’s conclusion, the children involved could join the open-label, single-arm extension study known as EXCURSION. Subjects participating in EXCURSION would be given dupilumab 100/200 mg therapy every 2 weeks or 300 mg every 4 weeks for an additional 52 weeks, the division of which the investigators based on subjects’ body weight at baseline.

The children who had been treated with dupilumab 200 mg on the every-2-week dosing regimen formed the largest cohort in both of the evaluated studies. The research team would consequently be able to assess the medication’s long-term safety and effectiveness. 

The team’s analysis covered the annualized rate of reported severe asthma exacerbations, in addition to changes in their prebronchodilator percent predicted forced expiratory volume in a single second (ppFEV1). They also looked at treatment-emergent adverse events (AEs) in both cohorts. 

In the study’s overall population, the research team concluded that dupilumab therapy had led to significantly reduced annualized exacerbation rates as well as improvement ppFEV1 among the 158 children who had been treated with the drug continuously for up to 2 years.

The team reported that there were comparable reductions in severe asthma exacerbations and ppFEV1 improvements that had been observed in the study among the 85 children initially given a placebo and then shifted to 200 mg of dupilumab every 2 weeks within the EXCURSION study.

Such positive results had also been shown by investigators to be consistent among children that were known to have type 2 asthma at the point of baseline. The investigators noted the consistency of dupilumab’s safety profile with its previously-established record of AEs.

“In summary, treatment with dupilumab 200 mg q2w led to improvements that were durable and significantly relevant in the clinical context of asthma control in children (aged 6–11 years) with uncontrolled moderate-to-severe type 2 asthma through reductions in severe exacerbations, improvements in lung function, and decline in levels of type 2 inflammatory biomarkers,” they wrote.

This article was initally published by our 

Phipatanakul W, Vogelberg C, Bacharier LB, et al. Dupilumab 200 mg was efficacious in children (6–11 years) with moderate-to-severe asthma for up to 2 years: EXCURSION open-label extension study. Pediatr Pulmonol. 2024; 1-8. doi:10.1002/ppul.27167.

Bacharier LB, Maspero JF, Katelaris CH, et al. Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open-label extension study. Lancet Respir Med. 2023; 12(1): 45-54.

These data highlighted new findings on the experiences of children aged 6 to 11 with uncontrolled type 2 asthma treated with dupilumab.

News

Dupilumab reduces exacerbations among children with severe asthma up to 2 years

 aimed to summarize the impact that various digital interventions for children and adolescents affected by obesity, as rapid development of socioeconomic growth and modernization over the last 2 decades have dramatically contributed to obesity rates.

Since 1975, the World Health Organization (WHO) estimated that the obesity percentage has nearly tripled, with childhood obesity being defined as a global epidemic that can lead to several comorbidities in adult life like diabetes, hyperlipidaemia, hypertension or hepatic steatosis, with authors noting "that the situation is destined to get worse."

The COVID-19 pandemic has further contributed to the rise in obesity rates, necessitating innovative strategies for prevention and treatment. The study focused on mobile health (mhealth) tools, telemedicine, and other technological innovations that can aid in the treatment and prevention of obesity in children and adolescents.

on how digital therapeutics can impact mental health in children, Jason Kahn, PhD, researcher at Boston Children’s Hospital, instructor of psychiatry at Harvard Medical School, and chief scientific officer and founder of the Mightier digital therapeutic, said  awareness of some of these technologies can make a difference too.

"Where digital therapies can step into the void if they can provide tools so kids can build skills, competencies, and strengths that can help them succeed and thrive while they are potentially on a waiting list for more specialized providers, these skills can then transfer into their lives," Kahn said. "With these tools, we see kids having more success and getting help earlier when available.”

Study authors each identified and reviewed the most appropriate published studies in order to collect a broad perspective on the use of new technological innovations to prevent and treat childhood obesity and associated characteristics and strengths. A comprehensive literature search was conducted using PubMed, Scopus, EMBASE, and Web of Science databases, focusing on studies published from 2013 to September 2023. Keywords related to childhood obesity, digital health, and technological interventions were used to identify relevant articles. The selected studies were reviewed and analyzed to assess the effectiveness and limitations of digital tools in childhood obesity management.

Telemedicine and text messages has been explored in managing children and adolescents with obesity, providing innovative access to health care. According to the investigators, data taken from randomized control trials (RCTs) and systematic reviews "have shown that telemedicine has been introduced into the management of obese [pediatric] patients through various technology-enhanced measures: telephone contact for obese children or other types of interventions, such as remote service delivery, video conferencing, short message service (SMS), and text messaging."

Review found that use of text messaging programs have been associated with changes in health behaviors such as fruit and vegetable consumption, low total caloric intake, physical activity, and screen time. Regarding telemedicine, good feasibility and fidelity characterize these interventions, with most studies having demonstrated high retention rates (e.g., 80%–100% among telemedicine groups) and high attendance at telemedicine appointments are the most commonly cited strengths of these tools.

The analysis revealed that digital health interventions, including mhealth applications, telemedicine, and digital therapeutics, show promise in supporting weight management and promoting healthy behaviors among children and adolescents. Telemedicine, in particular, has demonstrated high feasibility and patient satisfaction, although its long-term impact on BMI reduction remains unclear.

Authors concluded that digital technologies offer valuable tools for addressing childhood obesity, providing accessible and personalized interventions. However, the effectiveness of these tools is influenced by factors such as socioeconomic status, ethnicity, and the integration of in-person support. Future research should focus on optimizing these interventions to ensure they are effective across diverse populations and sustainable in the long term.

"Sustaining long-term engagement with mhealth technologies designed for health purposes remains a challenge. Strategies to maintain user's interest and motivation over extended periods of time are crucial for ensuring continued participation and benefit," the study authors noted.

Porri D, Morabito LA, Cavallaro P, et al. Time to act on childhood obesity: the use of technology. 

. 2024;12:1359484. doi:10.3389/fped.2024.1359484

Fitch, J. Digital therapeutics and what they can do for mental health. 

. August 8, 2024. Accessed August 8, 2024. https://www.contemporarypediatrics.com/view/digital-therapeutics-and-what-they-can-do-for-mental-health

Digital tools like health apps, texts, and telemedicine show promise in managing childhood obesity, but require sustained engagement for long-term impact. 

Digital health programs and childhood obesity 

The FDA recently alerted parents and caregivers of 

safety concerns linked to Crecelac Infant Powdered Goat Milk Infant Formula.

According to the alert, the federal agency conducted an abbreviated nutrient analysis of the formula and found both elevated levels of potassium and chloride, and low levels of vitamin A. The potassium and chloride levels were "significantly above the levels permitted in infant formula in the [United States] and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time," the FDA said in the alert. The agency also noted that low vitamin A intake could lead to loss of vision from deficiency, if the infant formula is used for an "extended period of time."

The products in the alert include (images at right)

CRECELAC INFANT Powdered Goat-Milk Infant Formula with Iron 0 to 12 months - Net Wt. 12.4 oz (352g) 

Farmalac BABY Powdered Infant Formula with Iron 0 to 12 months Net Wt. 12.4 oz (352g) 

Farmalac BABY Powdered Infant Formula with Iron Low Lactose 0 to 12 months Net Wt. 12.4 oz (352g) 

The products are being sold at some retail locations in Texas, and possibly at additional locations in the United States, according to the FDA. Dairy Manufacturers Inc issued a voluntary recall of the products on May 24, 2024. However, "because they were not in compliance with all of the FDA’s infant formula regulations, the FDA is now issuing this safety alert due to new findings of 

 contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula," the federal agency stated.

infection, a bacterium that can cause bloodstream and central nervous system infections, could lead to complications in infants such as brain abscess, developmental delays, motor impairments, and death.

The FDA is also alerting caregivers and parents to a recall initiated by the company of the Farmalac products because of their failure to meet infant formula regulations in the United States. The FDA noted that sampling of the Farmalac products did not result in 

detection, though the firm has not submitted the required premarket notification to the FDA demonstrating the safety and nutritional adequacy of the formula. The federal agency continues to work with the firm and relative distributors to ensure the recall is executed.

Poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements are possible symptoms of 

infection in infants. As of July 31, 2024, the FDA was not aware of any illnesses associated with the aforementioned products, nor does the FDA anticipate any impact on the supply of infant formula based on these recalls.

The FDA is advising caregivers and parents not to feed the affected infant formula products to infants under their care and to seek immediate care if the infant is experiencing 

FDA alerts parents and caregivers to cronobacter safety concerns with Crecelac Goat Milk Infant Formula imported and distributed by Dairy Manufactureres Inc. FDA. Press release. July 31, 2024. Accessed August 5, 2024. https://www.fda.gov/food/alerts-advisories-safety-information/fda-alerts-parents-and-caregivers-cronobacter-safety-concerns-crecelac-goat-milk-infant-formula?utm_medium=email&utm_source=govdelivery

Dairy Manufacturers Inc. issues voluntary recall of products due to non-compliance with requirements under the 21 CFR 106.110 new infant formula registration. FDA. Press release. May 25, 2024. Accessed August 5, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21

The formula company issued a recall of the products on May 24, 2024, though they were not in compliance with all of the FDA’s infant formula regulations.

FDA alerting parents, caregivers of Cronobacter safety concerns in certain infant formula

Three of 5 youth suicide decedents did not have a documented preceding mental health diagnosis, according to a study published in 

The study aimed to examine the association of documented mental health diagnosis with sociodemographic and clinical characteristics, precipitating circumstances, and mechanism among youth suicide decedents.

Suicide was among the top 9 leading causes of death for people aged 10 to 64 years, and was the second leading cause of death for individuals aged 10 to 14 years and 25 to 34 years in 2022, respectively, according to data from the Centers for Disease Control and Prevention (CDC).

Investigators of the study, led by Sofia Chaudhary, MD, Department of Pediatrics and Emergency Medicine, Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, Georgia, noted that knowledge about potential sociodemographic differences in documented health diagnoses could guide prevention efforts. The investigative team noted that as suicide rates have increased, so have disparities.

"American Indian and Alaska Native youths have the highest rate of suicide overall (41.9 per 100 000 youths in 2020) while the rate of suicide has risen the fastest among Black youths (6.9 per 100 000 youths in 2010 and 12.9 per 100 000 youths in 2020, an 87% increase)," stated Chaudhary and authors.

"These disparities persisted and widened after the onset of the COVID-19 pandemic, which brought social isolation and stressors at home, decreased access to timely [mental health] services, and increased access to firearms," the authors added.

In a retrospective and cross-sectional approach, the study used data from the CDC National Violent Death Reporting System from 2010 to 2021 for youth suicide decedents aged 10 to 24 years. Previously documented presence of a mental health diagnosis was the primary outcome of the study, with associations evaluated by multivariable logistic regression.

In all, there were 40,618 youth suicide decedents aged 10 to 24 years (79.2% male), with 58.1% aged 20 to 24 years. Demographic data included:

Asian, Native Hawaiian, or Other Pacific Islander - 4.2%

There were 16,426 individuals (40.4%) who had a documented mental health diagnosis, while 19,027 (46.8%) died by firearms. Compared to White youths, the adjusted odds of having a mental health diagnosis were lower among youths who were:

American Indian or Alaska Native - adjusted odds ratio (aOR), 0.45; 95% CI, 0.39-0.51

Asian, Native Hawaiian, or Other Pacific Islander - aOR, 0.58; 95% CI, 0.52-0.64

aOR of having a mental health diagnosis were also, "lower among Hispanic youths (aOR, 0.76; 95% CI, 0.72-0.82) compared with non-Hispanic youths; lower among youths aged 10 to 14 years (aOR, 0.70; 95% CI, 0.65-0.76) compared with youths aged 20 to 24 years; and higher for females (aOR, 1.64; 95% CI, 1.56-1.73) than males," the investigators found.

For those who died by firearms (19,027), a mental health diagnosis was documented for 6308 (33.2%) youth. Documentation was available for 1691 of 2743 youths who died by poisonings (61.6%), 7017 of 15,331 youths who died by hanging, strangulation, or suffocation (45.8%), and 1407 of 3181 youths who died by other mechanisms (44.2%).

According to study results, where 3 of 5 youth suicide decedents did not have a documented preceding mental health diagnosis, the odds of having this diagnosis were lower for racially and ethnically minoritized youths compared to White youths, as were odds for youth who died of suicides by firearm compared to other mechanisms.

"These findings underscore the critical need to increase equitable access to mental health screening, diagnosis, and treatment for all youths," the authors wrote.

"Given the low rates of [mental health] diagnoses among youth suicide decedents, prevention efforts must also address family and life stressors in tandem with [mental health] risk factors. Both increased identification of unmet [mental health] needs and universal, community-based approaches are needed to prevent youth suicide," concluded the investigative team.

Chaudhary S, Hoffmann JA, Pulcini CD, et al. Youth suicide and preceding mental health diagnosis. 

 2024;7(7):e2423996. doi:10.1001/jamanetworkopen.2024.23996

Facts about suicide. Centers for Disease Control and Prevention. Updated April 25, 2024. Accessed August 6, 2024. https://www.cdc.gov/suicide/facts/index.html 

Suicide was among the top 9 leading causes of death for people aged 10 to 64 years, and was the second leading cause of death for individuals aged 10 to 14 years and 25 to 34 years in 2022.

Youth suicide decedents and documented preceding mental health diagnosis

Fostering healthy microbiota in the gut has been an emerging and significant subject of study within the gastrointestinal specialty. One area that is being studied if taking probiotics would cultivate healthier microbiota.

For the uninitiated, probiotics can include supplements and food products and often include the lactic acid bacteria.

 Gram-positive microbes that have been used for centuries in food production processes and include items such as yogurt, cheese, and pickles.

A secondary analysis of a randomized trial points to limited benefits on the microbiota.

Joseph Grant Cramer, MD, FAAP

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